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NCT03501537 Clinical Trial

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

Peri-Implantitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03501537
Other study ID # 18002909C
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2018
Est. completion date May 1, 2019

Study information
Verified date April 2020
Source Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date May 1, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Spain Centro de Implantologia Cirugia Oral y Maxilofacial Badajoz

Sponsors (1)
Lead Sponsor Collaborator
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Association of keratinised mucosa/gingiva with periodontal and peri-implant conditions keratinised mucosa (mm) and keratinised gingiva (mm) 12 months after implant loading
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