NCT03312582

Brief Summary

This study evaluates the efficacy of 1% local metformin gel in deep periimplant pockets of type 2 diabetes mellitus patients. Half of the participants will receive 1% metformin gel with manual debridement while the other half will receive a placebo with manual debridement.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2015

Typical duration for phase_4

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2017

Completed
Last Updated

October 17, 2017

Status Verified

October 1, 2017

Enrollment Period

1.4 years

First QC Date

October 12, 2017

Last Update Submit

October 12, 2017

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (2)

  • Marginal bone loss

    Marginal bone loss will be assessed on digital radiographs on calibrated computer screen.

    6 months

  • Peri-implant prpbing depth

    Will be measured with UNC-15 periodontal probe from crest of the gingival margin to the base of the peri-implant probing depth.

    6 months

Study Arms (2)

Manual debridement and 1% metformin gel

EXPERIMENTAL
Drug: 1% local metformin gel

Manual debridement and placebo

PLACEBO COMPARATOR
Procedure: Placebo

Interventions

1% local metformin gelDRUG

After providing manual debridement in deep peri-implant probing depths, 1% metformin gel will be applied.

Manual debridement and 1% metformin gel
PlaceboPROCEDURE
Also known as: After providing manual debridement in deep peri-implant probing depths, placebo gel will be applied.
Manual debridement and placebo

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus patients.
  • Patients with peri-implantitis

You may not qualify if:

  • History of any other systemic diseases
  • Cigarette smokers
  • Smokeless tobacco users
  • Patients who underwent scaling in the last 1 year
  • Patients who took antibiotics in tje past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Clinical Research

Study Record Dates

First Submitted

October 12, 2017

First Posted

October 17, 2017

Study Start

March 15, 2015

Primary Completion

August 14, 2016

Study Completion

July 24, 2017

Last Updated

October 17, 2017

Record last verified: 2017-10