Clinical trial NCT03533166: Effects of a 0.03% CHX Mouth Rinse in Peri-implant Mucositis
Official title: Clinical and Microbiological Effects of a 0.03% Chlorhexidine Mouth Rinse in the Prevention of Peri-implant Diseases: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implant Mucositis
Keywords: Peri-implant mucositis
Chlorhexidine
CPC
Treatment
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Dentaid SL
First posted: 2018-05-23
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change on bleeding on probing on implants
timeFrame: Change baseline-12 months
Secondary outcomes:
measure: Bleeding on probing (BOP) on implants
timeFrame: Baseline
measure: Bleeding on probing (BOP) on implants
timeFrame: 3 months
measure: Bleeding on probing (BOP) on implants
timeFrame: 6 months
measure: Bleeding on probing (BOP) on implants
timeFrame: 9 months
measure: Bleeding on probing (BOP) on implants
timeFrame: 12 months
measure: Bleeding on probing (BOP) on teeth
timeFrame: Baseline
measure: Bleeding on probing (BOP) on teeth
timeFrame: 6 months
measure: Bleeding on probing (BOP) on teeth
timeFrame: 12 months
measure: Plaque on implants
timeFrame: Baseline
measure: Plaque on implants
timeFrame: 6 months
measure: Plaque on implants
timeFrame: 12 months
measure: Plaque on teeth
timeFrame: Baseline
measure: Plaque on teeth
timeFrame: 6 months
measure: Plaque on teeth
timeFrame: 12 months
measure: Probing depth on implants
timeFrame: Baseline
measure: Probing depth on implants
timeFrame: 6 months
measure: Probing depth on implants
timeFrame: 12 months
measure: Probing depth on teeth
timeFrame: Baseline
measure: Probing depth on teeth
timeFrame: 6 months
measure: Probing depth on teeth
timeFrame: 12 months
measure: Crown-length implant
timeFrame: Baseline
measure: Crown-length implant
timeFrame: 6 months
measure: Crown-length implant
timeFrame: 12 months
measure: Recession on teeth
timeFrame: Baseline
measure: Recession on teeth
timeFrame: 6 months
measure: Recession on teeth
timeFrame: 12 months
measure: Microbiological outcomes_total counts
timeFrame: Baseline
measure: Microbiological outcomes_total counts
timeFrame: 6 months
measure: Microbiological outcomes_total counts
timeFrame: 12 months
measure: Microbiological outcomes_frequency of detection
timeFrame: Baseline
measure: Microbiological outcomes_frequency of detection
timeFrame: 6 months
measure: Microbiological outcomes_frequency of detection
timeFrame: 12 months
measure: Microbiological outcomes_proportions
timeFrame: Baseline
measure: Microbiological outcomes_proportions
timeFrame: 6 months
measure: Microbiological outcomes_proportions
timeFrame: 12 months
measure: Radiographic bone loss on implants
timeFrame: Baseline
measure: Radiographic bone loss on implants
timeFrame: 3 months
measure: Radiographic bone loss on implants
timeFrame: 12 months
measure: Staining
timeFrame: Baseline
measure: Staining
timeFrame: 6 months
measure: Staining
timeFrame: 12 months
measure: Adverse effect
timeFrame: Baseline
measure: Adverse effect
timeFrame: 6 months
measure: Adverse effect
timeFrame: 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Faculty of Dentistry, Univesity Complutense, Madrid
Study officials:
affiliation: University Complutense Madrid (UCM)
name: Mariano Sanz, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Complutense Madrid
name: David Herrera, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bollain J, Pulcini A, Sanz-Sanchez I, Figuero E, Alonso B, Sanz M, Herrera D. Efficacy of a 0.03% chlorhexidine and 0.05% cetylpyridinium chloride mouth rinse in reducing inflammation around the teeth and implants: a randomized clinical trial. Clin Oral Investig. 2021 Apr;25(4):1729-1741. doi: 10.1007/s00784-020-03474-3. Epub 2020 Jul 31.
citation: Pulcini A, Bollain J, Sanz-Sanchez I, Figuero E, Alonso B, Sanz M, Herrera D. Clinical effects of the adjunctive use of a 0.03% chlorhexidine and 0.05% cetylpyridinium chloride mouth rinse in the management of peri-implant diseases: A randomized clinical trial. J Clin Periodontol. 2019 Mar;46(3):342-353. doi: 10.1111/jcpe.13088.