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

NCT ID: NCT06302322

Last Updated: 2024-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-07

Study Completion Date

2022-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Edentulous Alveolar Ridge

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Natural Thin Gums

Group Type EXPERIMENTAL

Thin Tissues

Intervention Type PROCEDURE

Patients with thin tissues received implants 10 years ago and are now followed up after 10 years.

Natural Thick Gums

Group Type EXPERIMENTAL

Thick Tissues

Intervention Type PROCEDURE

Patients with thick tissues received implants 10 years ago and are now followed up after 10 years.

Surgically augmented Thin Gums

Group Type EXPERIMENTAL

Surgically augmented thin tissues

Intervention Type PROCEDURE

Patients with thin tissues received soft tissue augmentation and implants 10 years ago and are now followed up after 10 years.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Thin Tissues

Patients with thin tissues received implants 10 years ago and are now followed up after 10 years.

Intervention Type PROCEDURE

Thick Tissues

Patients with thick tissues received implants 10 years ago and are now followed up after 10 years.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.

Exclusion Criteria

The exclusion criteria included poor oral hygiene, history of uncontrolled periodontitis, smoking, diabetes, alcoholism, and medication influencing healing.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

German O. Gallucci

Associate Professor and Chair Department of Restorative Dentistry and Biomaterials Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

VIC Clinic

Vilnius, , Lithuania

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Lithuania

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24313250 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

158200-07-512-149

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.