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

Influence of Mucosal Tissue Height on Implant Crestal Bone Stability: A Longitudinal 10-year Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Edentulous Alveolar Ridge
• Intervention / Treatment: Procedure: Thin Tissues; Procedure: Thick Tissues; Procedure: Surgically augmented thin tissues

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 Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania, 01362
    • VIC Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

The inclusion criteria for the study were individuals aged 18 years or older, generally healthy with no medical contraindications for implant surgery, missing teeth in the lower jaw posterior area, at least 6 mm bone width, healthy soft tissue, at least 2 mm keratinized gingiva buccally and lingually, no bone augmentation procedures before or during implant placement, and a signed informed consent form. The exclusion criteria included poor oral hygiene, history of uncontrolled periodontitis, smoking, diabetes, alcoholism, and medication influencing healing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Natural Thin Gums	Procedure: Thin Tissues; Patients with thin tissues received implants 10 years ago and are now followed up after 10 years.
Experimental: Natural Thick Gums	Procedure: Thick Tissues; Patients with thick tissues received implants 10 years ago and are now followed up after 10 years.
Experimental: Surgically augmented Thin Gums	Procedure: Surgically augmented thin tissues; Patients with thin tissues received soft tissue augmentation and implants 10 years ago and are now followed up after 10 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crestal Bone Levels	Assessment of changes in crestal bone level (CBL)	10 year follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PPD	Pocket probing depth	10 year follow up
BOP	Bleeding on Probing	10 year follow up
PI	Plaque Index	10 year follow up

Collaborators and Investigators

• Sponsor: Harvard Medical School (HMS and HSDM)

Publications and helpful links

General Publications

• Puisys A, Linkevicius T. The influence of mucosal tissue thickening on crestal bone stability around bone-level implants. A prospective controlled clinical trial. Clin Oral Implants Res. 2015 Feb;26(2):123-9. doi: 10.1111/clr.12301. Epub 2013 Dec 9.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2021
• Primary Completion (Actual): August 15, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: dental implant; phenotype; bone resorption; bone formation; bone remodeling; mucosal tissues; mucosal tissue augmentation; vertical soft tissue height
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: 158200-07-512-149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to make de-identified individual participant data (IPD) from our study on dental implant techniques available to other researchers upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No