Preventive Maintenance Therapy on Peri-implant Diseases

Periodontal Disease Clinical Trial

— PIMT  

Official title:

Influence of Maintenance Therapy on Peri-implant Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02789306
• Other study ID #: 18002909
• Status: Completed
• Phase: N/A
• First received: May 23, 2016
• Last updated: April 24, 2017
• Start date: May 2016
• Est. completion date: March 1, 2017

Study information

• Verified date: April 2017
• Source: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In the field of periodontics, periodontal support therapy has proven to be essential in preventing the incidence or recurrence of periodontal diseases. The protocol is designed according to the risk profile of a patient. For example, in the presence of the history of periodontal therapy, subgingival microbiota containing large numbers of spirochetes and mobile rods can recolonize pockets 4-8 weeks after scaling. Similarly, routine maintenance of dental implants has been recommended to prudently avoid peri-implant inflammation, Indeed, the understanding of the nature of the tissue around the implant and its pattern of disease would be important to consider, even surpassing importance. Recently, a systematic review by our group has identified the importance of maintenance therapy around implants because it can help prevent about 3 times patient-level frequency peri-implantitis.

Henceforth, our primary goal was to study the influence in a cross-sectional study of the frequency of peri-implantitis patients according to their post-implant placement and corresponding prosthesis visits supportive peri-implant maintenance. As such, it will be shown:

1. What are the local and systemic factors affecting the appearance of peri-implantitis

2. The ideal frequency of supportive peri-implant maintenance in patients who do not develop peri-implant disease

3. What is the population of patients who come to supportive peri-implant maintenance after placement of dental implants

Description:

Cross-sectional analysis that will include consecutive patients with dental implants (> 250) with at least 36 months depending upon placement of the prosthesis. a cross-sectional study calling patients to whom implants have placed them in two private practices (CICOM, Badajoz and Nart Clinica Dental, Barcelona, Spain) in the last 36 month to conduct clinical and radiographic study was performed. This procedure is justified because of the high frequency of peri-implant disease (30%) and since there is no predictable and effective treatment, only prevention can improve the success rate and functionality.

• Clinical examination

A previously examiner (AN) calibrated perform all clinical measurements. The following clinical parameters were measured at six sites per implant (mesiobuccal, buccal, distobuccal, distolingual, lingual and mesiolingual):

1. Presence of plaque is recorded as 0 (no) or 1 (presence)

2. Degree of gingival redness recorded as 0 (no) or 1 (presence)

3. Depth bag measured from the gingival margin to the base of the bag in mm;

4. clinical attachment level (CAL) by the number of exposed threads measured

5. Bleeding on probing (BOP) recorded as 0 (no) or 1 (presence)

6. Discharge is recorded as 0 (no) or 1 (presence)

7. keratinized gingiva (mm)

• Radiographic parameters A previously calibrated examiner perform radiographic measurement from the neck of the implant in the mesial and distal aspect of the implants using a digitized periapical. The software used for measurements will be ImageJ (approved by the American National Institute for Research - 'NIH')

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: March 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Eligibility criteria:

• Inclusion criteria

1. Patients between 18 and 80 years old

2. Consecutive patients that received dental implants in the last 36 months

3. Patients with partial edentulism

4. No antibiotic in the last 2 months

5. Non-smoking or smoking <10 cigarettes a day

• Exclusion Criteria

1. Uncontrolled systemic diseases

2. Implants because prosthetic characteristics can not be registered probing depth or attachment level appropriately

3. Smoking> 10 cigarettes a day

4. Pregnant patients

5. Implants not placed in our center

Related Conditions & MeSH terms

• Gingival Diseases
• Peri-Implantitis
• Periimplantitis
• Periodontal Disease
• Periodontal Diseases

Intervention

Procedure:
• Epidemiological study on the incidence of peri-implantitis
Clinical and radiographic examination in the routine based protocol

Locations

Country	Name	City	State
Spain	Florencio Monje Gil	Badajoz

Sponsors (2)

Lead Sponsor	Collaborator
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain	Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Monje A, Aranda L, Diaz KT, Alarcón MA, Bagramian RA, Wang HL, Catena A. Impact of Maintenance Therapy for the Prevention of Peri-implant Diseases: A Systematic Review and Meta-analysis. J Dent Res. 2016 Apr;95(4):372-9. doi: 10.1177/0022034515622432. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of peri-implantitis	'Peri-implant health' - Absence of bleeding or inflammation; 'Peri-implant mucositis' - Presence of bleeding (inflammation) but without bone loss; 'Peri-implantitis' - Lost of radiographic bone from the implant neck; Early:> 4 mm probing depth; <25% radiographic bone loss; Moderate:> 6mm probing depth; <50% radiographic bone loss; Severe:> 8 mm probing depth; > 50% radiographic bone loss	12 months
Secondary	Compliance of patients	Every three months - 'compliers'; Every 6 months - 'compliers'; Between 6-12 months - 'erratic'; Sporadically - 'erratic'; Never after placement of restoration - 'non compliers'	12 months
Secondary	Local and systemic factors on peri-implantitis	Sex (M / H); Age (years); Presence of periodontal disease in remaining teeth (determined by attachment level, probing depth, radiographic bone loss and presence of bleeding and / or discharge). By severity it will be stratified into 3 groups according to the 2015 American Academy of Periodontology (AAP): Mild: Probing depth 3-5mm; bone loss <15%; Moderate: Probing depth: 5-7mm; 15-30% bone loss; Severe: Probing depth:> 7 mm; bone loss> 30%; By location it will be stratified into two groups: Generalized:> 30%; Localized: <30%; 5. Diabetes (Yes / No - blood glucose level mg / dl) 6. History of periodontal disease (Yes / No) 7. Time from implant placement (always> 6months after restoration) 8. Location of the implant; Posterior maxilla (MP); Anterior maxilla (MA); Mandibular posterior (mp); Mandibular anterior (ma)	12 months