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

Edentulous Alveolar Ridge Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06302322
• Other study ID #: 158200-07-512-149
• Status: Completed
• Phase: N/A
• Start date: January 7, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: March 2024
• Source: Harvard Medical School (HMS and HSDM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: October 1, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Edentulous Alveolar Ridge
• Mouth, Edentulous

Intervention

Procedure:
• Thin Tissues
Patients with thin tissues received implants 10 years ago and are now followed up after 10 years.
• Thick Tissues
Patients with thick tissues received implants 10 years ago and are now followed up after 10 years.
• 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.

Locations

Country	Name	City	State
Lithuania	VIC Clinic	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Harvard Medical School (HMS and HSDM)

Country where clinical trial is conducted

Lithuania, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crestal Bone Levels	Assessment of changes in crestal bone level (CBL)	10 year follow up
Secondary	PPD	Pocket probing depth	10 year follow up
Secondary	BOP	Bleeding on Probing	10 year follow up
Secondary	PI	Plaque Index	10 year follow up