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

Primary Purpose

Peri-Implantitis, Soft Tissue, Bone Gain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Free gingival graft obtained from the palate and debridement of the peri-implant lesion
Sponsored by
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-Implantitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centro de Implantologia Cirugia Oral y Maxilofacial

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surgical treatment with free gingival graft

Arm Description

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

Outcomes

Primary Outcome Measures

Peri-implant conditions
Probing pocket depth measured in mm, bleeding on probing recorded as yes/no (I/0), suppuration as recorded as yes/no (I/0)

Secondary Outcome Measures

Association of keratinised mucosa/gingiva with periodontal and peri-implant conditions
keratinised mucosa (mm) and keratinised gingiva (mm)

Full Information

First Posted
April 4, 2018
Last Updated
April 27, 2020
Sponsor
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT03501537
Brief Title
Association of Keratinised Mucosa Around Implants and Teeth With Peri-implant/Periodontal Disease and Soft Tissue Conditioning
Official Title
Soft Tissue Conditioning to for the Treatment of Peri-implantitis in the Lack of Keratinised Mucosa
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis, Soft Tissue, Bone Gain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-prospective one-arm study
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical treatment with free gingival graft
Arm Type
Experimental
Arm Description
Free gingival graft harvested from the palate will be placed around the diseased implant
Intervention Type
Procedure
Intervention Name(s)
Free gingival graft obtained from the palate and debridement of the peri-implant lesion
Intervention Description
granulation tissue debridement and grafting of a free gingival strip obtained from the palate
Primary Outcome Measure Information:
Title
Peri-implant conditions
Description
Probing pocket depth measured in mm, bleeding on probing recorded as yes/no (I/0), suppuration as recorded as yes/no (I/0)
Time Frame
12 months after implant loading
Secondary Outcome Measure Information:
Title
Association of keratinised mucosa/gingiva with periodontal and peri-implant conditions
Description
keratinised mucosa (mm) and keratinised gingiva (mm)
Time Frame
12 months after implant loading

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Centro de Implantologia Cirugia Oral y Maxilofacial
City
Badajoz
ZIP/Postal Code
06011
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24611985
Citation
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.
Results Reference
result
PubMed Identifier
30461016
Citation
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.
Results Reference
derived

Learn more about this trial

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

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