NCT06302322

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

1.6 years

First QC Date

March 4, 2024

Last Update Submit

March 4, 2024

Conditions

Keywords

dental implantphenotypemucosal tissuesmucosal tissue augmentationvertical soft tissue heightbone resorptionbone remodelingbone formation

Outcome Measures

Primary Outcomes (1)

  • Crestal Bone Levels

    Assessment of changes in crestal bone level (CBL)

    10 year follow up

Secondary Outcomes (3)

  • PPD

    10 year follow up

  • BOP

    10 year follow up

  • PI

    10 year follow up

Study Arms (3)

Natural Thin Gums

EXPERIMENTAL
Procedure: Thin Tissues

Natural Thick Gums

EXPERIMENTAL
Procedure: Thick Tissues

Surgically augmented Thin Gums

EXPERIMENTAL
Procedure: Surgically augmented thin tissues

Interventions

Thin TissuesPROCEDURE

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

Natural Thin Gums
Thick TissuesPROCEDURE

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

Natural Thick Gums

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

Surgically augmented Thin Gums

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VIC Clinic

Vilnius, 01362, Lithuania

Location

Related Publications (1)

  • 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.

    PMID: 24313250BACKGROUND

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Chair Department of Restorative Dentistry and Biomaterials Sciences

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 8, 2024

Study Start

January 7, 2021

Primary Completion

August 15, 2022

Study Completion

October 1, 2022

Last Updated

March 8, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

We plan to make de-identified individual participant data (IPD) from our study on dental implant techniques available to other researchers upon request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations