Implant Stability QuotientNCT07687615
Cover Screw vs Healing Abutment on Osseointegration
A study testing Healing Abutment and Cover Screw in people with Implant Stability Quotient and Healing Abutment, run by Zeliha Başak Çakır Erdil at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Implant Stability Quotient, Healing Abutment, Cover Screw
- What is being tested?
- Healing Abutment and Cover Screw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Feb 2025to 24 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Dentistry, Adıyaman University
Adıyaman, Merkez, 02030
About this study
Official title: EFFECTS OF COVER SCREW AND HEALING ABUTMENT ON EARLY IMPLANT STABILITY: A RANDOMIZED CONTROLLED CLINICAL TRIAL
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.
Read the detailed description
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.
- Conditions
- Implant Stability Quotient, Healing Abutment, Cover Screw
- Being tested
- Healing Abutment, Cover Screw
- Keywords
- Osseointegration, Implant, Randomized controlled trial, Implant stability quotient, Osseointegration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healing AbutmentDevice
A healing abutment was connected to the dental implant immediately after implant placement using a one-stage surgical protocol.
Cover ScrewDevice
A cover screw was connected to the dental implant immediately after implant placement using a conventional two-stage surgical protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Cover Screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (implant placement) to 3 months after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start26 Feb 2025
- Primary completion24 Mar 2026
- Study completion24 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Stability QuotientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeliha Başak Çakır Erdil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeliha Başak Çakır Erdil, Adiyaman University
- Investigators
- METİN çalışır, Prof.Dr., Study director, Department of Periodontology, Faculty of Dentistry, Adıyaman University, Adıyaman, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687615
- Sponsor's protocol ID
- HRU-25.04.15
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because of institutional policies and the need to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF COVER SCREW AND HEALING ABUTMENT ON EARLY IMPLANT STABILITY: A RANDOMIZED CONTROLLED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT07687615
- Acronym / sponsor ID
- HRU-25.04.15
- Conditions
- Implant Stability Quotient, Healing Abutment, Cover Screw
- Keywords
- Osseointegration, Implant, Randomized controlled trial, Implant stability quotient, Osseointegration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zeliha Başak Çakır ErdilUniversity, hospital or other
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 24 Mar 2026 (actual)
- Study completion
- 24 Mar 2026 (actual)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healing Abutment | Experimental | Device: Healing AbutmentDental 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. |
| Cover Screw | Active comparator | Device: Cover ScrewDental 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healing AbutmentA healing abutment was connected to the dental implant immediately after implant placement using a one-stage surgical protocol. | Device | Healing Abutment |
| Cover ScrewA cover screw was connected to the dental implant immediately after implant placement using a conventional two-stage surgical protocol. | Device | Cover Screw |
Primary outcome
Change in Implant Stability Quotient (ISQ)
Time frame: Baseline (implant placement) to 3 months after implant placement
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because of institutional policies and the need to protect participant confidentiality.
Related trials for Implant Stability Quotient
Not yet recruiting
Blue®M Gel Versus Hyaluronic Acid for Stability of Immediately Loaded Dental Implants
Dental Implants, Immediate Dental Implant Loading
Recruiting
Effect of Implant Macro-Design and Surface Treatment on Insertion Torque and Early Implant Stability Quotient (ISQ)
Dental Implant Macrodesign, Dental Implant Surface Treatment
RecruitingObservational study
Immediate Molar Implants With Customized Healing Abutments in Different Post-Extraction Socket Classes
Tooth Loss, Alveolar Bone Loss
Recruiting
Photofunctionalization With UVC
Implant Site Reaction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
METİN çalışır, Prof.Dr. study director
Department of Periodontology, Faculty of Dentistry, Adıyaman University, Adıyaman, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healing Abutment and Cover Screw in people with Implant Stability Quotient and Healing Abutment, run by Zeliha Başak Çakır Erdil at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Implant Stability Quotient (ISQ) (time frame: Baseline (implant placement) to 3 months after implant placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.