Effect of Cover Screws and Healing Abutments on Marginal Bone Loss

NCT07815977 | Active Not Recruiting

• 1 other identifier: HRU/26.01.58
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial aims to compare the effects of using a cover screw or a healing abutment during dental implant placement on short-term marginal bone loss. Participants receiving dental implants will be randomly assigned to either the cover screw group or the healing abutment group. Marginal bone levels around the implants will be evaluated radiographically at baseline and at the 3-month follow-up. The study aims to determine whether the healing approach used at the time of implant placement affects marginal bone level changes during the early healing period.

Conditions

Dental Implant; Marginal Bone Loss

Keywords

Dental Implants; Marginal Bone Loss; Cover Screw; Healing Abutment; Peri-Implant Bone

Outcome Measures

Primary Outcomes (1)

• Change in Peri-Implant Marginal Bone Level

  Peri-implant marginal bone levels will be measured on periapical radiographs obtained using the paralleling technique. The distance from the implant reference point to the marginal bone level will be measured in millimeters at the mesial and distal aspects of each implant. Marginal bone level change will be determined by comparing the baseline measurement with the 3-month measurement.

  Baseline and 3 months after implant placement

Study Arms (2)

Cover Screw Group

EXPERIMENTAL

Following dental implant placement, a cover screw is connected to the implant, and the implant is allowed to heal using a submerged healing approach. Peri-implant marginal bone levels are evaluated radiographically using periapical radiographs obtained with the paralleling technique at baseline and at 3 months.

Device: Cover Screw

Healing Abutment Group

EXPERIMENTAL

Following dental implant placement, a healing abutment is connected to the implant, and the implant is allowed to heal using a transmucosal healing approach. Peri-implant marginal bone levels are evaluated radiographically using periapical radiographs obtained with the paralleling technique at baseline and at 3 months.

Device: Healing Abutment

Interventions

Cover Screw DEVICE

A cover screw is connected to the dental implant at the time of implant placement

Cover Screw Group

Healing Abutment DEVICE

A healing abutment is connected to the dental implant at the time of implant

Healing Abutment Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years
• Systemically healthy individuals
• Non-smokers
• Adequate alveolar bone height and width for implant placement without the -need for bone augmentation or regenerative procedures
• Adequate keratinized mucosal width (\>2 mm) at the planned implant site
• Indication for dental implant treatment

You may not qualify if:

• Presence of systemic disease or medical conditions that may contraindicate -implant surgery or affect bone healing
• Current smoking or use of tobacco products
• Insufficient alveolar bone height or width requiring bone augmentation or regenerative procedures at the implant site
• Keratinized mucosal width ≤2 mm at the planned implant site
• Presence of conditions that preclude standard dental implant placement
• Inability or unwillingness to attend the 3-month follow-up visit

Sponsors & Collaborators

• Adiyaman University: lead

Study Sites (1)

Faculty of Dentistry, Adıyaman University

Adıyaman, Adıyaman Province, 02030, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking was applied because the type of healing approach (cover screw or healing abutment) could be identified during clinical and radiographic assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Periodontology

Model Details: Participants are randomly assigned to one of two parallel groups: a cover screw (submerged healing) group or a healing abutment (transmucosal healing) group. Peri-implant marginal bone level changes are evaluated radiographically over a 3-month follow-up period.

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: January 15, 2026
• Primary Completion: September 17, 2026
• Study Completion: September 17, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: Data will be available to qualified researchers upon reasonable request for scientifically valid research purposes, subject to approval by the corresponding author and applicable ethical and institutional requirements.

Locations

TU (1)