Non-Surgical Treatment of Peri-Implantitis With Ultrasonic Carbon Tip

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-12-01

Brief Summary

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As the frequency of dental implants increases, the incidence of complications and peri-implant diseases also increases. Early diagnosis and treatment of the disease is important to prevent consequences up to implant loss. Non-surgical treatment is the recommended treatment in the first stage due to its shorter duration and low morbidity rate. Non-surgical treatment of peri-implantitis provides clinical improvements such as reduced bleeding on probing (20-50%) and, in some cases, reduced pocket depth (≤ 1 mm). This study aims to clinically and radiographically compare two different mechanical treatments in patients with mild and moderate peri-implantitis.

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Detailed Description

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60 patients with at least one implant with mild to moderate peri-implantitis, defined as 2-4 mm radiographic reduced bone level, bleeding index (BI) ≥ 2, and probing pocket depth (PPD) ≥ 4 mm will be randomly allocated to test and control groups, receiving titanium curettes or ultrasonic Carbon tips debridement, respectively. Treatment was performed at baseline. Plaque index (PI), gingival index (GI), Periodontal pocket depth (PD), Bleeding on probing (BOP) gingival recession (GR) and Clinical attachment level (CAL) will be measured at four sites per implant and recorded by examiner at baseline, one, three, six and twelve months. Pus will be recorded as present/not present. The radiographic marginal bone level changes will be calculated at baseline, third months, sixth months and 12 months.

Conditions

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Peri-Implantitis Alveolar Bone Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group I: Using Ultrasonic Carbon Tip for Non-surgical Peri-implantitis Treatment Group II: Using Titanium Curettes for for Non-surgical Peri-implantitis Treatment

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

For Outcomes Assessor Masking, Groups were not defined and anonymized and assessor will be blind.

Study Groups

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Ultrasonic Carbon

Using Ultrasonic Carbon Tip for Non-surgical Peri-implantitis Treatment

Group Type EXPERIMENTAL

Ultrasonic Carbon Tip

Intervention Type PROCEDURE

Using Ultrasonic Carbon Tip for Non-surgical Peri-implantitis Treatment

Titanium

Using Titanium Curettes for for Non-surgical Peri-implantitis Treatment

Group Type ACTIVE_COMPARATOR

Titanium Curette

Intervention Type PROCEDURE

Using Titanium Curettes for for Non-surgical Peri-implantitis Treatment

Interventions

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Ultrasonic Carbon Tip

Using Ultrasonic Carbon Tip for Non-surgical Peri-implantitis Treatment

Intervention Type PROCEDURE

Titanium Curette

Using Titanium Curettes for for Non-surgical Peri-implantitis Treatment

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Adult patients (≥18 years old)
2. Systemically healthy (ASA class 1 and ASA class 2)
3. Full-mouth plaque scores ≤20%
4. Implant had been in function for more than 6 months
5. Absence of plaque around the implant
6. Consent to complete all follow-up visits

Exclusion Criteria

1. Mobile implant
2. Overhanging restorations that prevent access to the implant for clinical measurements
3. Unresolvable technical complications that can cause peri-implantitis
4. Presence of active periodontal disease
5. Implants with a history of peri-implantitis treated using graft materials
6. Use of drugs that cause gingival hyperplasia
7. Systemic antibiotic use in the last 3 months
8. Acute and chronic medical conditions that prevent the patient from participating in the study
9. Presence of uncontrolled severe peri-implantitis from neighbouring implants
10. History of radiotherapy in the head and neck region
11. Receiving acute chemotherapy
12. Current corticosteroid therapy

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes