Association of Keratinised Mucosa Around Implants and Teeth With Peri-implant/Periodontal Disease and Soft Tissue Conditioning

April 27, 2020 updated by: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Soft Tissue Conditioning to for the Treatment of Peri-implantitis in the Lack of Keratinised Mucosa

Lack of keratinised mucosa around dental implants and teeth is associated with plaque accumulation and worse tissue conditions. However, there is lack of data on the influence of the presence/lack of keratinised mucosa on the periodontal condition. Hence, soft tissue conditioning by grafting with a gingival graft is aimed at improving the quality of the peri-implant conditions

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badajoz, Spain, 06011
        • Centro de Implantologia Cirugia Oral y Maxilofacial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Partial edentulous patients with adjacent teeth
  • Lack of keratinised mucosa
  • Healthy patient

Exclusion Criteria:

  • Pregnancy
  • Complete edentulous patients
  • Patients taking any medication
  • Smokers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgical treatment with free gingival graft
Free gingival graft harvested from the palate will be placed around the diseased implant
Procedure: Free gingival graft obtained from the palate and debridement of the peri-implant lesion
granulation tissue debridement and grafting of a free gingival strip obtained from the palate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri-implant conditions
Time Frame: 12 months after implant loading
Probing pocket depth measured in mm, bleeding on probing recorded as yes/no (I/0), suppuration as recorded as yes/no (I/0)
12 months after implant loading

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association of keratinised mucosa/gingiva with periodontal and peri-implant conditions
Time Frame: 12 months after implant loading
keratinised mucosa (mm) and keratinised gingiva (mm)
12 months after implant loading

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

April 4, 2018

First Submitted That Met QC Criteria

April 16, 2018

First Posted (Actual)

April 18, 2018

Study Record Updates

Last Update Posted (Actual)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 27, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18002909C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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