Effects of a 0.03% CHX Mouth Rinse in Peri-implant Mucositis

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

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-04

Study Completion Date

2017-04-07

Brief Summary

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Aim: To evaluate the efficacy of a 0.03% chlorhexidine (CHX) and 0.05% cetyl pyridinium chloride (CPC) mouth rinse, as an adjunct to professionally and patient-administered mechanical plaque removal, in the treatment of peri-implant mucositis.

Material and Methods: Patients displaying peri-implant mucositis in, at least, one implant were included in this randomized, double-blinded, clinical trial. Subjects received a conventional professional prophylaxis (at baseline and 6-month visits) and were instructed to regular oral hygiene practices and to rinse, twice daily, during one year, with a 0.03% CHX and 0.05% CPC mouth rinse, or a placebo. Clinical, radiographic and microbiological data were recorded at baseline, 6 and 12 months. Disease resolution was defined as the absence of bleeding on probing (BOP). Repeated measures ANOVA, Student-t and chi square tests were used.

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Detailed Description

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Conditions

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Peri-implant Mucositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Chlorhexidine

Mechanical treatment + 0.03% chlorhexidine + 0.05% CPC mouthrinse

Group Type EXPERIMENTAL

Chlorhexidine

Intervention Type OTHER

0.03% Chlorhexidine + 0.05% CPC mouth rinse

Placebo

Mechanical treatment + Placebo mouth rinse

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo mouth rinse

Interventions

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Chlorhexidine

0.03% Chlorhexidine + 0.05% CPC mouth rinse

Intervention Type OTHER

Placebo

Placebo mouth rinse

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* the presence of, at least, one dental implant with clinical signs of peri-implant mucositis, defined as gently bleeding on probing (BOP) and/or suppuration without progressive radiographic bone loss (after at least 1 year of functional loading)

Exclusion Criteria

* untreated or recurrent periodontitis \[presence of nine or more sites with PD 5 mm and with full mouth bleeding score (FMBS) \> 25%\];
* implants affected by peri-implantitis, (BOP and/or suppuration and progressive radiographic bone loss);
* removable implant-retained prosthesis;
* history of intake of systemic antibiotics within the previous month or other chronic systemic medications that could interfere with the study outcomes;
* and women being pregnant or breast-feeding.

Eligible Sex

ALL

Accepts Healthy Volunteers

No