Peri-implant Soft Tissue Phenotype and Early Marginal Bone Loss After Dental Implant Placement

NCT07769125 | Completed

• 1 other identifier: 10/13
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational cohort study evaluated the relationship between peri-implant soft tissue characteristics and early marginal bone loss following dental implant placement. The study included patients receiving bone-level implants in posterior edentulous regions. Keratinized mucosa width, supracrestal tissue height, and mucosal thickness were measured at the time of implant placement. Marginal bone levels were assessed using standardized intraoral radiographs obtained at baseline and three months after implant placement. The primary aim was to determine whether these peri-implant soft tissue dimensions were associated with marginal bone loss during the early healing period.

Conditions

Dental Implant

Keywords

dental implants; peri-implant soft tissue; peri-implant phenotype; marginal bone loss; keratinized mucosa; supracrestal tissue height; mucosal thickness

Outcome Measures

Primary Outcomes (1)

• Marginal Bone Loss Around Dental Implants

  Marginal bone loss was determined from standardized intraoral periapical radiographs obtained at implant placement (baseline) and at the three-month follow-up. Marginal bone level was measured on the mesial and distal aspects of each implant as the distance from the implant platform to the first bone-to-implant contact. Measurements were calibrated using the known implant length. Marginal bone loss was calculated as the change in marginal bone level from baseline to three months, and the mean of the mesial and distal measurements was used for analysis. Higher values indicate greater marginal bone loss.

  Baseline to 3 months after implant placement

Study Arms (1)

Patients Receiving Dental Implants

A single prospective cohort of patients receiving bone-level dental implants in posterior edentulous regions. Peri-implant soft tissue dimensions, including keratinized mucosa width, supracrestal tissue height, and mucosal thickness, were measured at implant placement. Participants were not assigned to groups based on these measurements; soft tissue dimensions were evaluated as observational exposure variables in relation to marginal bone changes during the three-month follow-up.

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the Department of Periodontology, Faculty of Dentistry, Ankara University, for implant-supported rehabilitation of posterior edentulous regions were considered for participation in this prospective cohort study. Eligible patients who underwent bone-level dental implant placement and agreed to participate were prospectively enrolled.

You may qualify if:

• Age between 20 and 60 years. Good general health. Need for dental implant treatment in a posterior edentulous region. Adequate native bone volume for implant placement without bone augmentation. At least 3 months since tooth extraction at the planned implant site. Presence of stable opposing teeth. Adequate oral hygiene. Ability to attend follow-up visits

You may not qualify if:

• Heavy smoking. Uncontrolled systemic disease. Pregnancy. Use of antibiotics or anti-inflammatory medications within the previous 3 months.
• Bruxism. Poor oral hygiene. Need for bone augmentation at the implant site.

Sponsors & Collaborators

• Karabuk University: lead

Study Sites (1)

Ankara University Faculty of Dentistry

Ankara, Ankara, 06560, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Prof Dr

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start: August 8, 2023
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)