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

NCT ID: NCT03501537

Last Updated: 2020-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2019-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peri-Implantitis Soft Tissue Bone Gain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-prospective one-arm study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Surgical treatment with free gingival graft

Free gingival graft harvested from the palate will be placed around the diseased implant

Group Type EXPERIMENTAL

Free gingival graft obtained from the palate and debridement of the peri-implant lesion

Intervention Type PROCEDURE

granulation tissue debridement and grafting of a free gingival strip obtained from the palate

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centro de Implantologia Cirugia Oral y Maxilofacial

Badajoz, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

Parpaiola A, Cecchinato D, Toia M, Bressan E, Speroni S, Lindhe J. Dimensions of the healthy gingiva and peri-implant mucosa. Clin Oral Implants Res. 2015 Jun;26(6):657-62. doi: 10.1111/clr.12359. Epub 2014 Feb 26.

Reference Type RESULT
PMID: 24611985 (View on PubMed)

Monje A, Blasi G. Significance of keratinized mucosa/gingiva on peri-implant and adjacent periodontal conditions in erratic maintenance compliers. J Periodontol. 2019 May;90(5):445-453. doi: 10.1002/JPER.18-0471. Epub 2018 Dec 7.

Reference Type DERIVED
PMID: 30461016 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18002909C

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.