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

U

Universidad Complutense de Madrid

Status

Completed

Conditions

Peri-implant Mucositis

Treatments

Other: Chlorhexidine
Other: Placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

54 participants in 2 patient groups, including a placebo group

Chlorhexidine
Experimental group
Description:
Mechanical treatment + 0.03% chlorhexidine + 0.05% CPC mouthrinse
Treatment:
Other: Chlorhexidine
Placebo
Placebo Comparator group
Description:
Mechanical treatment + Placebo mouth rinse
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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