Clinical trial NCT06302322: Long-term Follow up of Mucosal Tissue Height Influence on Peri-implant Bone Levels.
Official title: Influence of Mucosal Tissue Height on Implant Crestal Bone Stability: A Longitudinal 10-year Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Alveolar Ridge
Keywords: dental implant
phenotype
mucosal tissues
mucosal tissue augmentation
vertical soft tissue height
bone resorption
bone remodeling
bone formation
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

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

Primary outcomes:
measure: Crestal Bone Levels
timeFrame: 10 year follow up
Secondary outcomes:
measure: PPD
timeFrame: 10 year follow up
measure: BOP
timeFrame: 10 year follow up
measure: PI
timeFrame: 10 year follow up
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: VIC Clinic
Study officials:
References:
citation: 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.