Cover Screw vs Healing Abutment on Osseointegration

NCT07687615 | Completed

• 1 other identifier: HRU-25.04.15
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized split-mouth clinical trial aims to compare the effects of using a cover screw versus a healing abutment on early implant stability and osseointegration. Patients requiring at least two dental implants will receive both interventions in a split-mouth design, with one implant randomly assigned to the cover screw group and the contralateral implant assigned to the healing abutment group. Implant stability will be assessed using resonance frequency analysis (RFA) and Implant Stability Quotient (ISQ) measurements during the healing period.

Conditions

Implant Stability Quotient; Healing Abutment; Cover Screw

Keywords

Osseointegration, Implant; Randomized controlled trial; Implant stability quotient; Osseointegration

Outcome Measures

Primary Outcomes (1)

• Change in Implant Stability Quotient (ISQ)

  Implant stability was assessed using resonance frequency analysis (RFA). Changes in Implant Stability Quotient (ISQ) values from implant placement to the 3-month follow-up were compared between the healing abutment and cover screw groups.

  Baseline (implant placement) to 3 months after implant placement

Study Arms (2)

Healing Abutment

EXPERIMENTAL

Dental implants were restored with a healing abutment at the time of implant placement using a one-stage surgical protocol. Implant stability and osseointegration were evaluated during the follow-up period.

Device: Healing Abutment

Cover Screw

ACTIVE COMPARATOR

Dental implants were restored with a cover screw at the time of implant placement using a conventional two-stage surgical protocol. Implant stability and osseointegration were evaluated during the follow-up period.

Device: Cover Screw

Interventions

Healing Abutment DEVICE

A healing abutment was connected to the dental implant immediately after implant placement using a one-stage surgical protocol.

Healing Abutment

Cover Screw DEVICE

A cover screw was connected to the dental implant immediately after implant placement using a conventional two-stage surgical protocol.

Cover Screw

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥18 years. American Society of Anesthesiologists (ASA) physical status I or II. Able and willing to comply with the study protocol and follow-up schedule. Required at least two dental implants in contralateral or symmetrical edentulous sites.
• Implant sites free of active infection or acute periodontal disease. Adequate oral hygiene. Sufficient bone volume for placement of a standard-diameter implant with at least 1.5 mm of surrounding peri-implant bone.
• Keratinized mucosal width ≥2 mm. Soft tissue thickness ≥2 mm. Written informed consent provided.

You may not qualify if:

• Systemic diseases or medical conditions contraindicating implant surgery. Uncontrolled diabetes mellitus (HbA1c \>10%). Current intravenous antiresorptive therapy. History of head and neck radiotherapy. Immunosuppressive therapy. Active malignancy. Uncontrolled hypertension. Advanced hepatic or renal insufficiency. Pregnancy. Poor oral hygiene. Active oral infection. Requirement for bone augmentation before implant placement. Inadequate bone volume. Unfavorable peri-implant soft tissue phenotype. Primary implant stability \<20 Ncm at implant placement.

Sponsors & Collaborators

• Zeliha Başak Çakır Erdil: lead

Study Sites (1)

Faculty of Dentistry, Adıyaman University

Adıyaman, Merkez, 02030, Turkey (Türkiye)

Location

Study Officials

• METİN çalışır, Prof.Dr.

  Department of Periodontology, Faculty of Dentistry, Adıyaman University, Adıyaman, Turkey

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant in Periodontology

Model Details: This is a prospective randomized split-mouth clinical trial. Each participant receives both interventions, with one implant randomly assigned to the cover screw group and the contralateral implant assigned to the healing abutment group. Each participant serves as their own control, minimizing inter-individual variability.

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: February 26, 2025
• Primary Completion: March 24, 2026
• Study Completion: March 24, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)