Incidence of Peri-implant Mucositis in Patients With Treated Periodontitis

Peri-implant Mucositis Clinical Trial

— PiM_Inc  

Official title:

Incidence of Peri-implant Mucositis in Patients With Treated Periodontitis: a Prospective Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05356806
• Other study ID #: 52-240521
• Status: Recruiting
• Start date: January 10, 2022
• Est. completion date: June 2026

Study information

• Verified date: July 2023
• Source: Universidad Complutense de Madrid
• Contact: Elena F Figuero, Prof.
• Phone: 0034913942186
• Email: elfiguer[@]ucm.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

the objective of this study is to determine the incidence of peri-implant mucositis in patients with treated periodontitis and enrolled in periodontal maintenance and to evaluate the associated risk indicators. An analytical prospective observational study will be carried out, with an initial follow-up of 12 months.

Description:

Introduction: Peri-implant mucositis (PM) is an inflammatory disease induced by the accumulation of bacteria (biofilm) around dental implants, which can be modulated by individual characteristics of the patient, as well as by numerous factors related to a greater accumulation of biofilm in peri-implant tissues. Without correct regular maintenance, this entity can progress to peri-implantitis, a disease in which there is loss of bone supporting the implant. However, the strength of the association of the factors with the appearance of PM remains weak and incidence studies are limited due to their design and methodological inconsistencies. Therefore, the objective of this study is to determine the incidence of PM in patients with treated periodontitis and enrolled in periodontal maintenance and to evaluate the associated risk indicators.

Material and method: An analytical prospective observational study will be carried out, with an initial follow-up of 12 months. Patients with treated periodontitis and enrolled in periodontal maintenance will be selected, consecutively. They need to have implants placed in the Periodontics Specialist Clinic and are going to be rehabilitated at the UCM School of Dentistry. Peri-implant and periodontal clinical records, radiographic records, demographic variables, patient-based variables, and submucosal microbiological samples will be taken on the day of crown placement and after 6 and 12 months. The calculation of the sample size estimates the need to recruit 227 patients. The results will be analyzed using regression models.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 277
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years of age, able to comply with the protocol and comply with the established visits.

• Patients with treated periodontitis and enrolled in periodontal maintenance (last maintenance therapy received between 4 and 6 months maximum before inclusion in the study) (Chapple et al., 2018, Sanz et al., 2020).

• Patients with osseointegrated dental implants waiting for their prosthodontic rehabilitation (fixed prosthesis [individual, partial or complete], hybrid or overdenture).

• Physical or mental conditions that make it possible to perform appropiate oral hygiene

Exclusion Criteria:

• Patients with untreated periodontitis.

• Totally edentulous patients.

• Patients with peri-implant diseases.

• Pregnant or in lactating-period patients.

• Patients undergoing treatment with medication that affects the periodontal/peri-implant status or the immune system (phenytoin, calcium antagonists, corticosteroids or anti-inflammatories).

• Patients who have taken antibiotics in the last month.

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis
• Periodontitis

Intervention

Other:
• Supportive periodontal and periimplant care
Periodontal and peri-implant maintenance therapy will be carried out at baseline, 3 and 6-month visit. This session will include the removal of biofilm and calculus on teeth and implants (except those that have just been restored) with an ultrasonic device using a plastic tip ( for implants. and a conventional metal tip ( for teeth. At the end, polishing will be done with a rubber cup Subsequently, patients will be explained that they must continue with their usual oral hygiene technique on their teeth, using the same type of brush (which can be electric or manual), interproximal devices, toothpaste or mouthwash used to date. Finally, they will receive specific instructions for the supragingival biofilm control in the area of the new restoration and will be given interdental brushes that suit to the space

Locations

Country	Name	City	State
Spain	Faculty of Dentistry, University Complutense of Madrid (UCM)	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Dentaid SL, Sociedad Española de Periodoncia (SEPA)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of peri-implant mucositis	The risk of developing PM (patient with at least one implant who has bleeding on probing, with or without suppuration and without progressive radiographic bone loss) during a follow-up period of 12 months.	12 months
Secondary	Affiliation data	Age, Sex	Baseline
Secondary	previous medical history	systemic diseases, medication, allergies	Baseline
Secondary	smoking habit	ex-smoker/smoker/non-smoker	Baseline
Secondary	Other general data	sports habit, educational level, alcohol and coffee consumption, type of diet.	Baseline
Secondary	Previous dental history	history of periodontitis, periodontal treatment received (date of maintenance therapy, basic or surgical treatment), as well as the presence of previous peri-implant diseases will be recorded. Toothbrushing device used by the patient (manual or electric toothbrush) will also be recorded.	Baseline
Secondary	Characteristics of the teeth that have been replaced by implants	Options:single tooth in the anterior region, single tooth in the posterior region, tooth with distal extension, interdental space, edentulous upper jaw, edentulous lower jaw	Baseline
Secondary	Surgical procedure	bone regeneration procedures (prior, simultaneous, immediate implant), alveolar preservation, use of platelet derivatives, use of bone graft (autologous, xenogenic, mixed), use of membranes, sinus lift or soft tissue augmentation.	Baseline
Secondary	Implant characteristics	location (maxillary, mandibular, both), implant system (brand, implant position relative to bone and soft tissue, platform change, configuration, implant material), surface topography (roughness index), diameter and length (measured in millimeters),	Baseline
Secondary	Characteristics of the restorations	existence or not of an intermediate abutment and its characteristics, retention of the crown (cemented, screw-retained, cement-retained or other), type of prosthetic restoration (fixed prosthesis [individual, partial or complete], hybrid or overdenture ), crown material (metal-porcelain, ceramic, zirconium or resin), crown design method (CAD-CAM/casting) and impression-taking method (intraoral scanner, registration with silicone measurements) and if there are clinical signs of bruxism	Baseline
Secondary	Mucosal thickness (GM)	it will be measured with a K45 file (Stainless Steal K-File, Dentsply Maillefer, Ballaigues, Switzerland) and PCP15 periodontal probe calibrated in millimeters (HuFriedy® , Chicago, IL, USA), 1 mm from mucosal margin and at the buccal and lingual center of each implant.	Baseline
Secondary	Mucosal height	(once the abutment/healing screw has been removed, before placing the restoration): distance from the margin of the peri-implant mucosa to the implant head. It will be measured with a PCP15 periodontal probe calibrated in millimeters (HuFriedy®, Chicago, IL, USA), in 6 locations for each implant.	Baseline
Secondary	Modified plaque index (mPI)	Score 0: no plaque detected; score 1: plaque is only recognized by passing a probe over the smooth marginal surface of the implant; score 2: the plaque is visible; score 3: abundance of soft plaque.	Baseline
Secondary	Modified plaque index (mPI)	Score 0: no plaque detected; score 1: plaque is only recognized by passing a probe over the smooth marginal surface of the implant; score 2: the plaque is visible; score 3: abundance of soft plaque.	6 months
Secondary	Modified plaque index (mPI)	Score 0: no plaque detected; score 1: plaque is only recognized by passing a probe over the smooth marginal surface of the implant; score 2: the plaque is visible; score 3: abundance of soft plaque.	12 months
Secondary	Modified sulcus bleeding Index (mBI)	Score 0: no bleeding when passing a periodontal probe along the mucosal margin adjacent to the implant; score 1: visible isolated bleeding point; score 2: the bleed forms a confluent red line in the margin; score 3: profuse bleeding.	Baseline
Secondary	Modified sulcus bleeding Index (mBI)	Score 0: no bleeding when passing a periodontal probe along the mucosal margin adjacent to the implant; score 1: visible isolated bleeding point; score 2: the bleed forms a confluent red line in the margin; score 3: profuse bleeding.	6 months
Secondary	Modified sulcus bleeding Index (mBI)	Score 0: no bleeding when passing a periodontal probe along the mucosal margin adjacent to the implant; score 1: visible isolated bleeding point; score 2: the bleed forms a confluent red line in the margin; score 3: profuse bleeding.	12 months
Secondary	Bleeding on probing (BOP)	assessed dichotomously within 15 seconds of probing. Bleeding must be clear (a spot bleed will not be considered positive).	Baseline
Secondary	Bleeding on probing (BOP)	assessed dichotomously within 15 seconds of probing. Bleeding must be clear (a spot bleed will not be considered positive).	6 months
Secondary	Bleeding on probing (BOP)	assessed dichotomously within 15 seconds of probing. Bleeding must be clear (a spot bleed will not be considered positive).	12 months
Secondary	Suppuration on probing (Sup):	evaluated dichotomously after probing.	Baseline
Secondary	Suppuration on probing (Sup):	evaluated dichotomously after probing.	6 months
Secondary	Suppuration on probing (Sup):	evaluated dichotomously after probing.	12 months
Secondary	Probing depth (PS)	defined as the distance in mm between the depth of the pocket and the margin of the peri-implant tissue.	Baseline
Secondary	Probing depth (PS)	defined as the distance in mm between the depth of the pocket and the margin of the peri-implant tissue.	6 months
Secondary	Probing depth (PS)	defined as the distance in mm between the depth of the pocket and the margin of the peri-implant tissue.	12 months
Secondary	Crown length (CL):	defined as the distance, in mm, between the incisal/occlusal part of the crown and the margin of the peri-implant tissue.	Baseline
Secondary	Crown length (CL):	defined as the distance, in mm, between the incisal/occlusal part of the crown and the margin of the peri-implant tissue.	6 months
Secondary	Crown length (CL):	defined as the distance, in mm, between the incisal/occlusal part of the crown and the margin of the peri-implant tissue.	12 months
Secondary	Width of the mucosa:	distance from the mucosal margin to the mucogingival line at the buccal and lingual center. It will be measured with a PCP15 periodontal probe calibrated in millimeters (HuFriedy®, Chicago, IL, USA).	Baseline
Secondary	Width of the mucosa:	distance from the mucosal margin to the mucogingival line at the buccal and lingual center. It will be measured with a PCP15 periodontal probe calibrated in millimeters (HuFriedy®, Chicago, IL, USA).	6 months
Secondary	Width of the mucosa:	distance from the mucosal margin to the mucogingival line at the buccal and lingual center. It will be measured with a PCP15 periodontal probe calibrated in millimeters (HuFriedy®, Chicago, IL, USA).	12 months
Secondary	full-mouth periodontal clinical parameters	will be recorded at 6 locations per tooth and implant with a PCP15 periodontal probe (HuFriedy®, Chicago, IL, USA). These include PS, recession (REC), BOP, clinical attachment level (CAL), plaque index (PI), Sup.	Baseline
Secondary	full-mouth periodontal clinical parameters	will be recorded at 6 locations per tooth and implant with a PCP15 periodontal probe (HuFriedy®, Chicago, IL, USA). These include PS, recession (REC), BOP, clinical attachment level (CAL), plaque index (PI), Sup.	6 months
Secondary	full-mouth periodontal clinical parameters	will be recorded at 6 locations per tooth and implant with a PCP15 periodontal probe (HuFriedy®, Chicago, IL, USA). These include PS, recession (REC), BOP, clinical attachment level (CAL), plaque index (PI), Sup.	12 months
Secondary	Radiographic bone level	defined as the distance between the implant shoulder and the first visible contact between the implant surface and the most apical position of the bone in mesial and distal. For transmucosal implants, the length of the intermediate abutment will not be taken into account. Implant distances (length and diameter) will be used for fit and distortion. In visit 1, a perpendicular line to the major axis of the implant will be drawn, coinciding with the position of the bone level, this reference will be the guide to assess possible discrepancies in the following visits.	Baseline
Secondary	Radiographic bone level	defined as the distance between the implant shoulder and the first visible contact between the implant surface and the most apical position of the bone in mesial and distal. For transmucosal implants, the length of the intermediate abutment will not be taken into account. Implant distances (length and diameter) will be used for fit and distortion. In visit 1, a perpendicular line to the major axis of the implant will be drawn, coinciding with the position of the bone level, this reference will be the guide to assess possible discrepancies in the following visits.	6 months
Secondary	Radiographic bone level	defined as the distance between the implant shoulder and the first visible contact between the implant surface and the most apical position of the bone in mesial and distal. For transmucosal implants, the length of the intermediate abutment will not be taken into account. Implant distances (length and diameter) will be used for fit and distortion. In visit 1, a perpendicular line to the major axis of the implant will be drawn, coinciding with the position of the bone level, this reference will be the guide to assess possible discrepancies in the following visits.	12 months
Secondary	Implant-Abutment Gap	Presence of space between implant and abutment and excess cement (surrounding excess cement will be explored).	Baseline
Secondary	Implant-Abutment Gap	Presence of space between implant and abutment and excess cement (surrounding excess cement will be explored).	6 months
Secondary	Implant-Abutment Gap	Presence of space between implant and abutment and excess cement (surrounding excess cement will be explored).	12 months
Secondary	Emergence angle and profile (concave/straight or convex) of restorations	The angle of the restoration will be measured mesial and distal according to the criteria established by Yotnuengnit et al. (Yotnuengnit et al., 2008). The emergence of the angle will be calculated between the length of the major axis of the implant and the tangent line to the restoration, then a tangential line is made from the restoration to the platform, the intersection angle is measured as an emergency angle. These measurements will be repeated twice for each mesial and distal surface. Each emergence profile will be categorized as concave, straight, or convex. For implants placed at bone level, the transmucosal abutment will be considered as a part of the restoration. According to this criterion, restorations with at least a 30º angle will be considered "over-contoured" (Kohal et al., 2003). Concave, convex and straight profile categories will awarded according to this emergency.	Baseline
Secondary	Emergence angle and profile (concave/straight or convex) of restorations	The angle of the restoration will be measured mesial and distal according to the criteria established by Yotnuengnit et al. (Yotnuengnit et al., 2008). The emergence of the angle will be calculated between the length of the major axis of the implant and the tangent line to the restoration, then a tangential line is made from the restoration to the platform, the intersection angle is measured as an emergency angle. These measurements will be repeated twice for each mesial and distal surface. Each emergence profile will be categorized as concave, straight, or convex. For implants placed at bone level, the transmucosal abutment will be considered as a part of the restoration. According to this criterion, restorations with at least a 30º angle will be considered "over-contoured" (Kohal et al., 2003). Concave, convex and straight profile categories will awarded according to this emergency.	6 months
Secondary	Emergence angle and profile (concave/straight or convex) of restorations	The angle of the restoration will be measured mesial and distal according to the criteria established by Yotnuengnit et al. (Yotnuengnit et al., 2008). The emergence of the angle will be calculated between the length of the major axis of the implant and the tangent line to the restoration, then a tangential line is made from the restoration to the platform, the intersection angle is measured as an emergency angle. These measurements will be repeated twice for each mesial and distal surface. Each emergence profile will be categorized as concave, straight, or convex. For implants placed at bone level, the transmucosal abutment will be considered as a part of the restoration. According to this criterion, restorations with at least a 30º angle will be considered "over-contoured" (Kohal et al., 2003). Concave, convex and straight profile categories will awarded according to this emergency.	12 months
Secondary	Patient reported outcomes	It will be recorded if the patient reports the appearance of pain in peri-implant tissues (no pain/slight pain/moderate pain/severe pain), need of analgesia (yes/no), inflammation (no inflammation/inflammation not visually perceived/evident inflammation) , bleeding (no bleeding/incipient bleeding when brushing/profuse bleeding when brushing), discomfort during brushing (no pain/slight pain/moderate pain/severe pain), collaboration (number of tooth brushings per day), oral hygiene habits (use of interproximal devices in the implants under study).; In addition, type of toothbrush (manual/electric/sonic) and its frequency, use of dental floss (yes/no), use of interproximal brushes (yes/no) and use of mouthrinse (yes/no; frequency, type of mouthwash).	Baseline
Secondary	Patient reported outcomes	It will be recorded if the patient reports the appearance of pain in peri-implant tissues (no pain/slight pain/moderate pain/severe pain), need of analgesia (yes/no), inflammation (no inflammation/inflammation not visually perceived/evident inflammation) , bleeding (no bleeding/incipient bleeding when brushing/profuse bleeding when brushing), discomfort during brushing (no pain/slight pain/moderate pain/severe pain), collaboration (number of tooth brushings per day), oral hygiene habits (use of interproximal devices in the implants under study).; In addition, type of toothbrush (manual/electric/sonic) and its frequency, use of dental floss (yes/no), use of interproximal brushes (yes/no) and use of mouthrinse (yes/no; frequency, type of mouthwash).	6 months
Secondary	Patient reported outcomes	It will be recorded if the patient reports the appearance of pain in peri-implant tissues (no pain/slight pain/moderate pain/severe pain), need of analgesia (yes/no), inflammation (no inflammation/inflammation not visually perceived/evident inflammation) , bleeding (no bleeding/incipient bleeding when brushing/profuse bleeding when brushing), discomfort during brushing (no pain/slight pain/moderate pain/severe pain), collaboration (number of tooth brushings per day), oral hygiene habits (use of interproximal devices in the implants under study).; In addition, type of toothbrush (manual/electric/sonic) and its frequency, use of dental floss (yes/no), use of interproximal brushes (yes/no) and use of mouthrinse (yes/no; frequency, type of mouthwash).	12 months
Secondary	Microbiological samples	2 most accessible and/or inflamed locations will be selected. After careful removal of supramucosal biofilm deposits, if any, the areas of interest will be isolated using cotton rolls and air drying. Two sterile paper points (#30, Maillefer, Ballaigues, Switzerland) will be consecutively inserted into the peri-implant sulcus for 30 seconds. Paper points taken from each implant will be placed in a sterile and empty vial and will be sent within a maximum period of 24 hours to the research laboratory of the UCM School of Dentistry for subsequent freezing and processing (Pulcini et al., 2019 ). Analysis of the microbiome using massive sequencing techniques	Baseline
Secondary	Microbiological samples	2 most accessible and/or inflamed locations will be selected. After careful removal of supramucosal biofilm deposits, if any, the areas of interest will be isolated using cotton rolls and air drying. Two sterile paper points (#30, Maillefer, Ballaigues, Switzerland) will be consecutively inserted into the peri-implant sulcus for 30 seconds. Paper points taken from each implant will be placed in a sterile and empty vial and will be sent within a maximum period of 24 hours to the research laboratory of the UCM School of Dentistry for subsequent freezing and processing (Pulcini et al., 2019 ). Analysis of the microbiome using massive sequencing techniques	6 months
Secondary	Microbiological samples	2 most accessible and/or inflamed locations will be selected. After careful removal of supramucosal biofilm deposits, if any, the areas of interest will be isolated using cotton rolls and air drying. Two sterile paper points (#30, Maillefer, Ballaigues, Switzerland) will be consecutively inserted into the peri-implant sulcus for 30 seconds. Paper points taken from each implant will be placed in a sterile and empty vial and will be sent within a maximum period of 24 hours to the research laboratory of the UCM School of Dentistry for subsequent freezing and processing (Pulcini et al., 2019 ). Analysis of the microbiome using massive sequencing techniques	12 months