The comparison between autogenous tooth and autogenous bone graft for phenotype modification around immediate implants

To compare the radiographic and clinical outcomes of autogenous dentin graft versus autogenous bone graft for modifying the peri-implant periodontal phenotype around immediately placed implants.

A randomized, single-blind, parallel-group, controlled clinical trial, conducted on 38 patients. For randomization, statistical software (SPSS Random Number Generator or Random Allocation Software) was used with a block randomization method.

This single-blind randomized clinical trial will enroll patients needing immediate anterior maxillary implants. The buccal gap will be filled with autogenous dentin (intervention) or bone graft (control), with a subepithelial connective tissue graft in both groups; outcome assessors and data analysts will be blinded. Patients will be followed for 6 months to evaluate buccal bone and soft tissue thickness, Pink Esthetic Score (PES), and implant survival.

Inclusion criteria: Patients requiring immediate implant placement in the anterior maxilla - Adequate bone and soft tissue for implant placement. Exclusion criteria: Systemic conditions or medications affecting bone healing - Poor oral hygiene or uncontrolled periodontal disease - Smokers or patients with habits that may compromise implant success - Sites with acute infection or insufficient bone for implant placement.

Intervention Group: Buccal gap filled with demineralized autogenous dentin graft after immediate implant placement, covered with a 1.5 mm subepithelial connective tissue graft from the palate. Control Group: Buccal gap filled with autogenous bone graft after immediate implant placement, covered with an identical 1.5 mm subepithelial connective tissue graft from the palate.

Buccal bone thickness; Soft tissue thickness; Pink Esthetic Score (PES); Implant survival

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.

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.