NCT02605382

Brief Summary

The purpose of this study is to analyze the efficacy of 0.12% chlorhexidine gluconate as a chemical adjuvant for the treatment of peri-implant mucositis, in a non-surgical treatment protocol with a six-month follow-up.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 16, 2015

Completed
Last Updated

November 16, 2015

Status Verified

November 1, 2015

Enrollment Period

1.2 years

First QC Date

October 7, 2015

Last Update Submit

November 12, 2015

Conditions

Mucositis

Keywords

Dental ImplantationChlorhexidine gluconate

Outcome Measures

Primary Outcomes (3)

  • Bleeding on probing

    baseline

  • Bleeding on probing

    three months

  • Bleeding on probing

    six months

Secondary Outcomes (1)

  • Probing depth

    baseline and at three and six months

Study Arms (2)

chlorhexidine gluconate

EXPERIMENTAL

15 ml of solution every 12 hours, twice a day, 30 minutes after brushing, for 14 days

Drug: Chlorhexidine gluconate

placebo

PLACEBO COMPARATOR

15 ml of solution every 12 hours, twice a day, 30 minutes after brushing, for 14 days

Drug: placebo

Interventions

Chlorhexidine gluconateDRUG
Also known as: Chlorhexidine
chlorhexidine gluconate
placeboDRUG

Solution chemical manufactured to mimic 0.12% chlorhexidine mouthwash

Also known as: placebo solution
placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Systemically-healthy partially edentulous patients rehabilitated with functional dental implants and prostheses for at least 1 year;
  • Patients had been diagnosed with peri-implant mucositis, probing depth up to 5 mm, bleeding on probing and no radiographic evidence of bone loss beyond the first two threads of the implant.

You may not qualify if:

  • Non-smokers and not in maintenance therapy;
  • Periodontal treatment during the last six months;
  • Have not used antimicrobial (systemic or topical), anti-inflammatory or immunosuppressive drugs during the six months preceding the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mucositis

Interventions

chlorhexidine gluconateChlorhexidine

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Bruno CV Gurgel, Doctor

    Universidade Federal do Rio Grande do Norte

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 7, 2015

First Posted

November 16, 2015

Study Start

October 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

November 16, 2015

Record last verified: 2015-11