Non-surgical Treatment of Periimplantitis - Conventional Hand Instrumentation Versus Air-polishing

Periimplantitis Clinical Trial

Official title:

Non-surgical Treatment of Periimplantitis - Conventional Hand Instrumentation Versus Air-polishing and Systemic Metronidazole With a 12 Months Follow-up, a Parallel Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05811390
• Other study ID #: Periimplantitis treatment
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2023
• Source: Universidade do Porto
• Contact: Ana Nogal Dias
• Phone: + 351 220 408 640
• Email: abdias[@]reit.up.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical efficacy of ultrasonic instrumentation versus the use of an erythritol jet in the treatment of peri-implantitis.

Description:

To carry out this study, the investigators considered a treatment protocol for periimplantitis consisting of 2 phases. The first phase corresponds to the non-surgical treatment of periimplantitis, which can be performed using various techniques. In the present study, it will be carried out using manual instrumentation (with ultrasound and curettes) or with an erythritol jet. In both cases, systemic antibiotic therapy with metronidazole will be performed. The results obtained during the follow-ups will allow the evaluation of the effectiveness of the treatment carried out. If this does not prove to be successful, through an evaluation of clinical and radiographic criteria, patients will be advised to undergo a second phase of treatment, in this case a surgical treatment of peri-implantitis, but which will no longer be part of the interventions carried out and documented in this study. Patients for whom the unsatisfactory treatment was considered effective will be allocated to a periimplant support treatment program, which means that they will be advised to carry out maintenance consultations at the FMDUP clinic with a specific and individualized periodicity in order to maintain the health of the periimplant tissues and the remaining oral cavity. The study will be carried out by the students of the Specialization in Periodontology and Oral Implantology 2021-2024 of the Faculty of Dental Medicine of the University of Porto (FMDUP).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 1 osseointegrated implant diagnosed with peri-implantitis (according to the new Classification of Periodontal and Peri-implant Diseases and Conditions) and rehabilitated with screw-retained crown

• Patients of legal age (=18 years old)

Exclusion Criteria:

• Uncontrolled systemic pathologies, namely diabetes mellitus (HbA1c > 7% or >53 mmol/mol)

• Pregnant or lactating patients

• Severe smoking (>20 cigarettes/day)

• Systemic pathologies, medication or treatments that cause alterations in bone metabolism (for example: osteoporosis, bisphosphonates, radiotherapy of the head and neck)

• Patients who missed study control visits

• Patients who have received systemic antibiotic therapy in the last 2 months

• Patients with allergies to any of the components used in the study, namely to erythritol

• Implants that have previously undergone surgical treatment for peri-implantitis

• Implants with bone loss greater than 2/3 of their length and/or mobility

Related Conditions & MeSH terms

• Peri-Implantitis
• Periimplantitis

Intervention

Device:
• erythritol jet
Use of an erythritol jet in the non-surgical treatment of periimplantitis together with systemic metronidazole
• Manual instrumentation
Use of manual instrumentation in the non-surgical treatment of periimplantitis together with systemic metronidazole

Locations

Country	Name	City	State
Portugal	Faculty of Dentistry at the University of OPorto	OPorto

Sponsors (2)

Lead Sponsor	Collaborator
Universidade do Porto	EMS

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in probing pocket depth	The distance measured from the base of the sulcus or pocket to the free gingival margin at six points per implant (measured in millimetres).	0, 3, 6, 12 months
Secondary	PROMS	Patient reported outcomes reported on a visual analog scale from 0 (no pain) to 10 (maximum pain).	0 months
Secondary	Change in alveolar bone level	Radiographically measured alveolar bone level from the alveolar crest to the implant's neck, mesially and distally (measured in millimetres).	0,12 months
Secondary	Change in gingival recession	Gingival recession measured at six points per implant with a periodontal probe, from the cementum-enamel junction to the bottom of the probable pocket (measured in millimetres).	0, 3, 6, 12 months
Secondary	Bleeding on probing	Bleeding on probing (in percentage) assessed 30 seconds after probing, through a dichotomous scoring system used at six sites per implant using one (1) and zero (0) for presence or absence, respectively.	0, 3, 6, 12 months
Secondary	Implant survival rate	Percentage of implants that survived after 1 year follow-up (implants that remain in the patient's mouth after 1 year).	0, 12 months