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OpenTrials
Completed

NCT Number: NCT06302322

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VIC Clinic

Vilnius, 01362, Lithuania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thin Tissues

Procedure

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

Thick Tissues

Procedure

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

Surgically augmented thin tissues

Procedure

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

Primary outcomes

  1. Crestal Bone Levels

    Time frame: 10 year follow up

    Assessment of changes in crestal bone level (CBL)

Secondary outcomes

  1. PPD

    Time frame: 10 year follow up

    Pocket probing depth

  2. BOP

    Time frame: 10 year follow up

    Bleeding on Probing

  3. PI

    Time frame: 10 year follow up

    Plaque Index

Sponsors and collaborators

Lead sponsor

Harvard Medical School (HMS and HSDM)

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 8, 2024
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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