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NCT Number: NCT07769125

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

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.

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Key information

Conditions

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara University Faculty of Dentistry

Ankara, 06560, Turkey (Türkiye)

About this study

This prospective observational cohort study was conducted at the Department of Periodontology, Faculty of Dentistry, Ankara University. Participants requiring implant-supported rehabilitation in posterior edentulous regions were prospectively enrolled and received bone-level dental implants according to a standardized surgical protocol. No participant was assigned to a treatment or exposure group for research purposes.

Peri-implant soft tissue dimensions were clinically assessed at the time of implant placement. Keratinized mucosa width was measured as the distance from the mucogingival junction to the mid-crestal point of the edentulous ridge. Supracrestal tissue height was determined following flap elevation as the vertical distance from the alveolar crest to the free gingival margin. Mucosal thickness was measured horizontally at the mid-buccal aspect using an endodontic file with a silicone stop.

Standardized intraoral periapical radiographs were obtained at implant placement and at the three-month follow-up using a parallel technique with individualized positioning. Radiographic measurements were calibrated according to the known implant length. Marginal bone level was determined on the mesial and distal aspects of each implant relative to the implant platform, and changes between baseline and the three-month follow-up were used to assess early marginal bone remodeling. Radiographic measurements were performed by a calibrated examiner blinded to the clinical soft tissue measurements.

The study was designed to examine the associations between peri-implant soft tissue dimensions and early marginal bone changes during healing after implant placement. Statistical analyses evaluated these relationships using both univariable and multivariable approaches while accounting for the distribution and structure of the collected data.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Marginal Bone Loss Around Dental Implants

    Time frame: Baseline to 3 months after implant placement

    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.

Sponsors and collaborators

Lead sponsor

Karabuk University

Other

Registry information

Official study title

Impact of Peri-implant Soft Tissue Phenotype on Early Marginal Bone Loss: A Prospective Cohort Study

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

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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