Association of Keratinised Mucosa Around Implants and Teeth With Peri-implant/Periodontal Disease and Soft Tissue Conditioning
Soft Tissue Conditioning to for the Treatment of Peri-implantitis in the Lack of Keratinised Mucosa
1 other identifier
interventional
37
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2018
1 active site
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
February 1, 2018
CompletedFirst Submitted
Initial submission to the registry
April 4, 2018
CompletedFirst Posted
Study publicly available on registry
April 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedApril 28, 2020
April 1, 2020
1.2 years
April 4, 2018
April 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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)
12 months after implant loading
Secondary Outcomes (1)
Association of keratinised mucosa/gingiva with periodontal and peri-implant conditions
12 months after implant loading
Study Arms (1)
Surgical treatment with free gingival graft
EXPERIMENTALFree gingival graft harvested from the palate will be placed around the diseased implant
Interventions
granulation tissue debridement and grafting of a free gingival strip obtained from the palate
Eligibility Criteria
You may qualify if:
- Partial edentulous patients with adjacent teeth
- Lack of keratinised mucosa
- Healthy patient
You may not qualify if:
- Pregnancy
- Complete edentulous patients
- Patients taking any medication
- Smokers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro de Implantologia Cirugia Oral y Maxilofacial
Badajoz, 06011, Spain
Related Publications (2)
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.
PMID: 24611985RESULTMonje 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.
PMID: 30461016DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2018
First Posted
April 18, 2018
Study Start
February 1, 2018
Primary Completion
May 1, 2019
Study Completion
May 1, 2019
Last Updated
April 28, 2020
Record last verified: 2020-04