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Standard- and Micro-Dose rhBMP-2 for Implant Stability, Marginal Bone Loss, and Postoperative Sequelae: A Double-Blind Randomized Controlled Trial (SMBMP)

6 juli 2026 uppdaterad av: Omer Tareq Mohammed, University of Baghdad

Comparative Evaluation of Standard- and Micro-Dose Recombinant Human BMP-2 on Implant Stability, Marginal Bone Loss, and Postoperative Sequelae: A Double-Blind Randomized Controlled Trial

This study will compare the effect of standard-dose and micro-dose recombinant human bone morphogenetic protein-2 (rhBMP-2) with a placebo control on dental implant stability in the posterior mandible. Sixty patients requiring a single dental implant will be randomly assigned to one of three groups: standard-dose rhBMP-2, micro-dose rhBMP-2, or sterile saline only. Implant stability will be measured using Resonance Frequency Analysis at baseline, 2 weeks, 4 weeks, and 12 weeks. Marginal bone loss, peri-implant bone density, ectopic bone formation, and postoperative sequelae including swelling, pain, trismus, and soft tissue healing will also be evaluated during follow-up. The aim is to determine whether micro-dose rhBMP-2 can improve implant stability while reducing postoperative complications compared with the standard dose.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This prospective, double-blind, randomized controlled clinical trial is designed to evaluate the effect of locally applied recombinant human bone morphogenetic protein-2 (rhBMP-2) on peri-implant stability, marginal bone loss, peri-implant bone density, postoperative sequelae, and ectopic bone formation following dental implant placement in the posterior mandible.

Sixty systemically healthy adult patients requiring a single implant-supported restoration in the posterior mandible will be enrolled and randomly allocated in a 1:1:1 ratio into three parallel groups (20 participants per group). Group A will receive the standard dose of rhBMP-2 (0.1 mg), Group B will receive a micro-dose of rhBMP-2 (0.02 mg), and Group C will receive sterile saline as the placebo control. Randomization will be computer-generated, and an independent assistant will prepare identical coded syringes to maintain allocation concealment. Patients, the operating surgeon, the clinical outcome assessor, and the statistician will remain blinded until completion of the final statistical analysis.

All implants will be placed by the same surgeon using the MegaGen AnyRidge implant system following a standardized surgical protocol. The allocated solution will be delivered into the prepared implant osteotomy immediately before implant insertion. Healing abutments will be connected at the time of surgery to allow non-invasive longitudinal resonance frequency analysis without disturbing the peri-implant tissues.

The primary outcome is peri-implant stability measured using Resonance Frequency Analysis (Osstell Beacon) at baseline, 2 weeks, 4 weeks, and 12 weeks after implant placement. Secondary outcomes include marginal bone loss and peri-implant bone density assessed using standardized CBCT at baseline, 6 months, and 12 months. Postoperative sequelae (pain, facial swelling, trismus, and early soft tissue healing) will be evaluated on postoperative days 1, 3, and 7. Ectopic bone formation will be assessed radiographically during follow-up. Statistical analyses will follow the intention-to-treat principle using repeated-measures and between-group analyses with statistical significance set at P < 0.05.

Studietyp

Interventionell

Inskrivning (Beräknad)

60

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Irak
    • Baghdad Governorate
      • Baghdad, Baghdad Governorate, Irak, 10001

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • Patients aged 20 to 55 years requiring a single dental implant for a single tooth missing in the posterior mandible (strictly limited to one implant per patient to prevent clustering effects and intra-subject correlation).

Patients must be systemically healthy or medically well-controlled, categorized as ASA I or ASA II according to the American Society of Anesthesiologists classification.

Surgical sites must exhibit D2 or D3 bone quality with adequate residual alveolar bone volume (minimum 6 mm width and 10 mm height).

Patients must maintain optimal oral hygiene, suitable for a prosthetically driven implant treatment workflow.

Exclusion Criteria:

  • Patients presenting with uncontrolled systemic conditions (e.g., unmanaged diabetes mellitus, active osteoporosis).

A history of radiotherapy or chemotherapy in the maxillofacial region. Current heavy smoking habits (>10 cigarettes per day). Active and untreated periodontal disease. Pregnancy or lactation.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Standard-dose rhBMP-2
Participants will receive local application of the standard dose of recombinant human bone morphogenetic protein-2 (rhBMP-2) into the implant osteotomy immediately before dental implant placement.
Biologisk: Standard-dose rhBMP-2
Standard-dose recombinant human bone morphogenetic protein-2 (rhBMP-2) is locally applied into the implant osteotomy immediately before implant placement at the manufacturer's recommended dose to enhance osseointegration and implant stability.
Andra namn:
  • Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)
Experimentell: Micro-dose rhBMP-2
Participants will receive local application of a micro-dose of recombinant human bone morphogenetic protein-2 (rhBMP-2) into the implant osteotomy immediately before dental implant placement.
Biologisk: Micro-dose rhBMP-2
Micro-dose recombinant human bone morphogenetic protein-2 (rhBMP-2) is locally applied into the implant osteotomy immediately before implant placement at a reduced dose to evaluate whether comparable implant stability can be achieved with fewer dose-related adverse effects.
Placebo-jämförare: Placebo Control
Participants will receive sterile normal saline applied into the implant osteotomy immediately before dental implant placement as the placebo control.
Läkemedel: Sterile Normal Saline
Sterile normal saline is locally applied into the implant osteotomy immediately before implant placement as the placebo control.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Peri-Implant Stability (Implant Stability Quotient [ISQ])
Tidsram: Baseline (immediately after implant placement), 2 weeks, 4 weeks, and 12 weeks after implant placement
Peri-implant stability will be quantitatively assessed using Resonance Frequency Analysis (RFA) with the Osstell Beacon device. ISQ values will be recorded from two orthogonal directions (buccolingual and mesiodistal), and the mean value will be used for analysis to compare implant stability among the three study groups.
Baseline (immediately after implant placement), 2 weeks, 4 weeks, and 12 weeks after implant placement

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Marginal Bone Loss
Tidsram: Baseline (immediately after implant placement), 6 months, and 12 months after implant placement
Marginal bone loss will be evaluated using standardized CBCT images. Linear measurements from the implant-abutment junction to the highest crestal bone level will be recorded at the mesial and distal aspects of each implant and compared among the three study groups.
Baseline (immediately after implant placement), 6 months, and 12 months after implant placement
Peri-Implant Bone Density
Tidsram: Baseline (immediately after implant placement), 6 months, and 12 months after implant placement
Peri-implant bone density will be evaluated using standardized CBCT scans. Bone density around the implant threads will be measured using Hounsfield Units (HU) or voxel gray values and compared among the three study groups to assess peri-implant bone remodeling.
Baseline (immediately after implant placement), 6 months, and 12 months after implant placement
Soft Tissue Swelling
Tidsram: Baseline, postoperative days 1, 3, and 7
Postoperative soft tissue swelling will be assessed using standardized linear facial measurements between predetermined anatomical landmarks. Measurements will be obtained preoperatively and postoperatively to compare the degree of swelling among the three study groups.
Baseline, postoperative days 1, 3, and 7
Pain Intensity (Visual Analog Scale [VAS])
Tidsram: Daily during the first postoperative week
Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Participants will record their pain scores at each assessment time point, and the results will be compared among the three study groups.
Daily during the first postoperative week
Trismus (Maximum Interincisal Distance)
Tidsram: Baseline, postoperative days 1, 3, and 7
Trismus will be assessed by measuring the maximum interincisal distance (MID) between the incisal edges of the upper and lower central incisors using a calibrated digital caliper. Measurements will be obtained at each assessment time point and compared among the three study groups.
Baseline, postoperative days 1, 3, and 7
Soft Tissue Healing Index (Landry Index)
Tidsram: Postoperative days 1, 3, and 7
Early soft tissue wound healing will be assessed using the validated Landry, Turnbull and Howley Healing Index. The index evaluates tissue color, bleeding on palpation, granulation tissue, epithelialization of the incision margin, and suppuration, with scores ranging from 1 (very poor healing) to 5 (excellent healing).
Postoperative days 1, 3, and 7
Ectopic Bone Formation
Tidsram: 6 months and 12 months after implant placement
Ectopic bone formation will be assessed radiographically using standardized CBCT images. The presence, location, and extent of ectopic bone formation around the implant healing abutment will be evaluated and compared among the three study groups.
6 months and 12 months after implant placement

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Baghdad

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 december 2026

Primärt slutförande (Beräknad)

1 mars 2028

Avslutad studie (Beräknad)

1 december 2028

Studieregistreringsdatum

Först inskickad

6 juli 2026

Först inskickad som uppfyllde QC-kriterierna

6 juli 2026

Första postat (Faktisk)

10 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • UOB-CD-PHD-2026-001

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Individual participant data will not be shared to protect participant confidentiality.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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