Cover Screw, Healing Abutment, Implant Stability Quotient
Conditions
Keywords
Osseointegration, Implant, Randomized controlled trial, Implant stability quotient, Osseointegration
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.
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.
Interventions
DEVICEHealing Abutment
A healing abutment was connected to the dental implant immediately after implant placement using a one-stage surgical protocol.
DEVICECover Screw
A cover screw was connected to the dental implant immediately after implant placement using a conventional two-stage surgical protocol.
Sponsors
Zeliha Başak Çakır Erdil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Implant Stability Quotient (ISQ) | 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. |
Countries
Turkey (Türkiye)
Contacts
STUDY_DIRECTORMETİN çalışır, Prof.Dr.
Department of Periodontology, Faculty of Dentistry, Adıyaman University, Adıyaman, Turkey
Outcome results
None listed