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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06302322
Enrollment
59
Registered
2024-03-08
Start date
2021-01-07
Completion date
2022-10-01
Last updated
2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulous Alveolar Ridge

Keywords

dental implant, phenotype, mucosal tissues, mucosal tissue augmentation, vertical soft tissue height, bone resorption, bone remodeling, bone formation

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.

Interventions

PROCEDUREThin Tissues

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

PROCEDUREThick Tissues

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

PROCEDURESurgically augmented thin tissues

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

Sponsors

Harvard Medical School (HMS and HSDM)
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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. The

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Crestal Bone Levels10 year follow upAssessment of changes in crestal bone level (CBL)

Secondary

MeasureTime frameDescription
PPD10 year follow upPocket probing depth
BOP10 year follow upBleeding on Probing
PI10 year follow upPlaque Index

Countries

Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026