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

NCT03533166 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2018-05-23

No results posted yet for this study

Summary

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.

Conditions

  • Peri-implant Mucositis

Interventions

OTHER

Chlorhexidine

0.03% Chlorhexidine + 0.05% CPC mouth rinse

OTHER

Placebo

Placebo mouth rinse

Sponsors & Collaborators

  • Dentaid SL

    collaborator INDUSTRY

  • Universidad Complutense de Madrid

    lead OTHER

Principal Investigators

  • Mariano Sanz, Doctor · University Complutense Madrid (UCM)

  • David Herrera, Doctor · University Complutense Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-04
Primary Completion
2017-03-25
Completion
2017-04-07

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03533166 on ClinicalTrials.gov