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IRCT20110726007128N11 IRCT 2025-09-26 Tabriz University of Medical Sciences Enhancing Dental Implants with Your Own Tooth or Bone: A Scientific Comparison The comparison between autogenous tooth and autogenous bone graft for phenotype modification around immediate implants 2025-09-23 anticipated 38 Complete https://irct.ir/trial/86072 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, participants will be allocated in a 1:1 ratio using block randomization with a block size of 4 to assign them to either the intervention or control group. Randomization will be performed at the individual level. The random sequence will be generated using statistical software (SPSS Random Number Generator or Random Allocation Software). To ensure allocation concealment, sequentially numbered, opaque, sealed envelopes (SNOSE) will be used. These envelopes will be prepared and safeguarded by an independent colleague not involved in the research team. After obtaining informed consent and confirming eligibility criteria, the envelope corresponding to the patient's inclusion order will be opened to reveal the assigned intervention type, Blinding description: Outcome Assessors a) Clinical Photograph Assessor (for Pink Esthetic Score - PES): Status: Blinded. Procedure: Standardized clinical photographs of the implant site will be taken at the 6-month follow-up. All photographs will be coded with a unique patient ID number that does not indicate the group allocation. A single, calibrated assessor, who is independent of the surgical team and has not been involved in the patient's care, will score all photographs using the PES index. This assessor will be explicitly blinded to the patient's group assignment. b) Radiographic Assessor (for Buccal Bone Thickness): Status: Blinded. Procedure: All Cone-Beam Computed Tomography (CBCT) scans taken pre-operatively and at 6 months will be analyzed using dedicated software. The scans will be de-identified and assigned random codes. A radiologist or a trained assessor, who is independent of the study and blinded to the group allocation and the time point (pre-op vs. 6-month), will measure the buccal bone thickness. The software screen will be set up to display only the coded image, hiding any patient or group identifiers. Data analyzer: Status: Blinded. Procedure: For the primary statistical analysis, the data file provided to the statistician will contain generic group labels (e.g., "Group A" and "Group B"). The identity of which group is the intervention (dentin graft) and which is the control (bone graft) will be concealed until after the analysis of all primary and secondary outcomes is complete and the results are finalized. N/A Periodontal disease. Intervention 1: Intervention group: After tooth extraction and site preparation, the implant is placed immediately in the anterior maxilla. The gap between the implant and the buccal socket wall is filled with a demineralized autogenous dentin graft prepared from the patient’s extracted tooth. A 1.5 millimeter thick subepithelial connective tissue graft is then harvested from the patient’s palate and placed over the implant and dentin graft, then sutured. All procedures are performed under local anesthesia. Preparation of the autogenous dentin graft: The extracted teeth are cleaned with ethyl alcohol, the root portions are collected and ground. The ground particles are placed in distilled water and hydrogen peroxide solution, then dehydrated in ethyl alcohol and ethyl ether, and finally partially demineralized in 2% nitric acid (HNO₃). Intervention 2: Control group: After tooth extraction and site preparation, the implant is placed immediately in the anterior maxilla. The gap between the implant and the buccal socket wall is filled with autogenous bone graft. A 1.5 millimeter thick subepithelial connective tissue graft is then harvested from the patient’s palate and placed over the implant and bone graft, then sutured. All procedures are performed under local anesthesia.The autogenous bone graft is harvested from the adjacent site of the surgical area using a bone scraper and shaped to fill the gap between the implant and the buccal socket wall. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Dr Adileh Shirmohamadi
Daneshgah street, Golgasht, Tabriz University of Medical Science
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 1335 5966 shirmohamadia@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr Adileh Shirmohamadi
Daneshgah street, Golgasht, Tabriz University of Medical Science
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 1335 5966 shirmohamadia@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Adults aged ≥ 18 years Systemic condition suitable for oral surgery (ASA I or II) Healthy periodontium in adjacent teeth (no probing depth ≥ 4 mm and no bleeding on probing) indication for immediate implant placement in the anterior region for endodontic or restorative reasons Ability and willingness to attend follow-up visits and provide informed consent 18 years no limit Both Poor oral hygiene (high Plaque Index or inability to maintain oral hygiene) Active smoking (>10 cigarettes/day or ≥10 pack-years) Pregnancy or breastfeeding Severe periodontal disease Uncontrolled diabetes (HbA1c > 7.0%) History of head and neck radiotherapy Current or past use of bisphosphonates, denosumab, or long-term systemic corticosteroids/immunosuppressants alcohol or substance abuse Systemic or metabolic bone diseases interfering with healing Inadequate bone anatomy to achieve primary implant stability inability or unwillingness to attend follow-up visits Active infection at the extraction site (clinical signs of infection or purulence) K05.6 Periodontal disease, unspecified Treatment - Surgery Treatment - Surgery Intervention group: After tooth extraction and site preparation, the implant is placed immediately in the anterior maxilla. The gap between the implant and the buccal socket wall is filled with a demineralized autogenous dentin graft prepared from the patient’s extracted tooth. A 1.5 millimeter thick subepithelial connective tissue graft is then harvested from the patient’s palate and placed over the implant and dentin graft, then sutured. All procedures are performed under local anesthesia. Preparation of the autogenous dentin graft: The extracted teeth are cleaned with ethyl alcohol, the root portions are collected and ground. The ground particles are placed in distilled water and hydrogen peroxide solution, then dehydrated in ethyl alcohol and ethyl ether, and finally partially demineralized in 2% nitric acid (HNO₃). Control group: After tooth extraction and site preparation, the implant is placed immediately in the anterior maxilla. The gap between the implant and the buccal socket wall is filled with autogenous bone graft. A 1.5 millimeter thick subepithelial connective tissue graft is then harvested from the patient’s palate and placed over the implant and bone graft, then sutured. All procedures are performed under local anesthesia.The autogenous bone graft is harvested from the adjacent site of the surgical area using a bone scraper and shaped to fill the gap between the implant and the buccal socket wall Buccal bone thickness. Timepoint: Measuring buccal bone thickness at the beginning of the study (before the intervention) and 6 months after surgery. Method of measurement: Measured using cone-beam computed tomography. Soft tissue thickness. Timepoint: Baseline (at implant placement)and 6 months after surgery. Method of measurement: Measured using a size 20 endodontic file with a silicone stop at 1 mm and 3 mm from the line connecting the marginal points of adjacent teeth. Pink Esthetic Score. Timepoint: 6 months after surgery, after placement of the implant prosthesis. Method of measurement: Assessed visually and scored according to the standard Pink Esthetic Score index. Implant survival. Timepoint: 6 months after surgery. Method of measurement: Evaluated clinically by recording implant mobility, infection, or loss. Tabriz University of Medical Sciences Approved 2025-01-27 Ethics Committee of Tabriz University of Medical Sciences Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)