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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.
This prospective randomized split-mouth controlled clinical trial evaluates the effects of cover screw placement and healing abutment placement on early implant stability and osseointegration. Systemically healthy patients requiring at least two dental implants will be enrolled. Using a split-mouth design, each participant will receive both interventions, with one implant randomly allocated to receive a cover screw (two-stage protocol) and the contralateral implant to receive a healing abutment (one-stage protocol).
Implant stability will be evaluated by insertion torque and resonance frequency analysis (RFA). Implant Stability Quotient (ISQ) values will be recorded at implant placement and at the 3-month follow-up. The primary objective is to compare changes in implant stability (ΔISQ) between the two treatment protocols. Secondary outcomes include implant survival, peri-implant soft tissue healing, and postoperative complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healing Abutment | Device | A healing abutment was connected to the dental implant immediately after implant placement using a one-stage surgical protocol. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| METİN çalışır, Prof.Dr. | Department of Periodontology, Faculty of Dentistry, Adıyaman University, Adıyaman, Turkey | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Adıyaman University | Adıyaman | Merkez | 02030 | Turkey (Türkiye) |
Individual participant data will not be shared because of institutional policies and the need to protect participant confidentiality.
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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.
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| Cover Screw | Device | A cover screw was connected to the dental implant immediately after implant placement using a conventional two-stage surgical protocol. |
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