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IRCT20260615069803N1 IRCT 2026-06-19 Mashhad University of Medical Sciences Evaluation of Marginal Bone Loss Around Crestal and Subcrustal Dental Implants Considering Crestal Soft Tissue Thickness: A Randomized Controlled Clinical Trial Comparison of Marginal Bone Loss Around Crestal and Subcrustal Dental Implants 2026-06-18 anticipated 40 Recruiting https://irct.ir/trial/90900 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Stratified Block Randomization, Blinding description: This is a single-blind randomized clinical trial. The radiographic evaluator is blinded to the implant placement type and group allocation. The surgeon and patients cannot be blinded due to the nature of the surgical intervention. Statistical analysis will also be performed by a blinded analyst. N/A Marginal bone loss around dental implants (Crestal and Subcrestal implant placement). Intervention group: Dental implant placement in crestal (at bone crest level) or subcrestal (2 mm below bone crest) position. All implants are from the Neodent system and placed using a standardized one-stage surgical protocol. The study follows a 2×2 factorial design (implant position × soft tissue thickness).. 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 The final decision regarding sharing of Individual Participant Data (IPD) will be made after completion of the study and data analysis
public Motahare Damavandi
Dental School, Mashhad University of Medical Sciences Beginning of Vakilabad Boulevard, opposite Mellat Park (or Azadi Square area), Mashhad, Iran
Mashhad Iran (Islamic Republic of) 91735 +98 51 3882 9501 motaharedmv@gmail.com Mashhad University of Medical Sciences scientific Motahare Damavandi
Dental School, Mashhad University of Medical Sciences Beginning of Vakilabad Boulevard, opposite Mellat Park (or Azadi Square area), Mashhad, Iran
Mashhad Iran (Islamic Republic of) 91735 +98 51 3882 9501 motaharedmv@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Age between 20 and 50 years Good general health Written informed consent Minimum bone width of 7 mm Minimum bone height of 13 mm At least 4 months after tooth extraction 20 years 50 years Both Systemic diseases Periodontal disease Drug abuse Poor oral hygiene Z46.3 Encounter for fitting and adjustment of dental prosthetic device Treatment - Surgery Intervention group: Dental implant placement in crestal (at bone crest level) or subcrestal (2 mm below bone crest) position. All implants are from the Neodent system and placed using a standardized one-stage surgical protocol. The study follows a 2×2 factorial design (implant position × soft tissue thickness). Marginal bone loss (MBL) at the mesial and distal aspects of dental implants, measured using parallel periapical radiographs. Timepoint: Baseline (immediately after implant placement), 3 months, and 6 months after implant placement. Method of measurement: Parallel periapical radiographs taken at mesial and distal sides of each implant. The distance from the implant-abutment junction to the first visible bone-to-implant contact will be measured using radiographic analysis software. Evaluation of peri-implant soft tissue parameters including Papilla Index, width of keratinized mucosa, and interproximal papilla status, as well as incidence of complications (peri-implantitis, infection, or implant failure). Timepoint: Baseline (immediately after placement), 3 months, and 6 months after implant placement. Method of measurement: Clinical examination by a periodontist and radiographic assessment when indicated. Mashhad University of Medical Sciences Approved 2026-03-10 Ethics Committee of Mashhad University of Medical Sciences No. 33, North Kosar Ave, Vakil Abad Blvd Mashhad Razavi Khorasan Iran (Islamic Republic of)