Long-term Follow up of Mucosal Tissue Height Influence on Peri-implant Bone Levels.

Not Applicable

Completed

• Conditions: Edentulous Alveolar Ridge
• Interventions: Procedure: Thick Tissues; Procedure: Thin Tissues; Procedure: Surgically augmented thin tissues

• Registration Number: NCT06302322
• Lead Sponsor: Harvard Medical School (HMS and HSDM)

Brief Summary

Our study looks into how the thickness of the gum tissue affects the health of the bone around dental implants over ten years. We include 59 people and divide them into three groups based on their gum tissue thickness. Some have naturally thin gums, some have thin gums that were made thicker with a special procedure, and some already had thick gums. We try to find out if having thicker gums, whether naturally or through enhancement, can help keep the bone around dental implants healthy in the long run.

Detailed Description

The protocol of our study focuses on understanding the impact of gum tissue thickness on the stability of the bone surrounding dental implants over a period of ten years. We enroll 59 participants and categorize them based on their initial gum thickness. The study groups included participants with naturally thin gums, participants whose thin gums were surgically enhanced with an allogenic tissue matrix to increase thickness, and participants with naturally thick gums. We monitore the bone levels around the implants using X-rays at baseline and annually, assessing any changes in bone health and stability. Our objective is to determine if and how the thickness of gum tissue influences long-term bone preservation around dental implants, aiming to provide insights into better implant care and outcomes.

Study Timeline

• Study Start: 2021-01-07
• Primary Completion: 2022-08-15
• Study Completion: 2022-10-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-04
• Last Update Submitted: 2024-03-04
• Study First Posted: 2024-03-08
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Natural Thick Gums	Thick Tissues	-
Natural Thin Gums	Thin Tissues	-
Surgically augmented Thin Gums	Surgically augmented thin tissues	-

Primary Outcome Measures

Name	Time	Method
Crestal Bone Levels	10 year follow up	Assessment of changes in crestal bone level (CBL)

Secondary Outcome Measures

Name	Time	Method
PPD	10 year follow up	Pocket probing depth
BOP	10 year follow up	Bleeding on Probing
PI	10 year follow up	Plaque Index

Trial Locations

Locations (1)

VIC Clinic; 🇱🇹 Vilnius, Lithuania