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

NCT07696299 | Not Yet Recruiting

• 1 other identifier: UOB-CD-PHD-2026-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tooth Loss / Rehabilitation; Dental Implant; Osseo-Integrated Implants

Keywords

rhbmp-2; Recombinant Human Bone Morphogenetic Protein-2; Dental Implant; Implant Stability; Micro-dose; Standard-dose; Osstell; Resonance Frequency Analysis; ISQ; Marginal Bone Loss; Peri-implant Bone Density; Posterior Mandible; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Peri-Implant Stability (Implant Stability Quotient [ISQ])

  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

Secondary Outcomes (7)

• Marginal Bone Loss

  Baseline (immediately after implant placement), 6 months, and 12 months after implant placement

• Peri-Implant Bone Density

  Baseline (immediately after implant placement), 6 months, and 12 months after implant placement

• Soft Tissue Swelling

  Baseline, postoperative days 1, 3, and 7

• Pain Intensity (Visual Analog Scale [VAS])

  Daily during the first postoperative week

• Trismus (Maximum Interincisal Distance)

  Baseline, postoperative days 1, 3, and 7

Study Arms (3)

Standard-dose rhBMP-2

EXPERIMENTAL

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.

Biological: Standard-dose rhBMP-2

Micro-dose rhBMP-2

EXPERIMENTAL

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.

Biological: Micro-dose rhBMP-2

Placebo Control

PLACEBO COMPARATOR

Participants will receive sterile normal saline applied into the implant osteotomy immediately before dental implant placement as the placebo control.

Drug: Sterile Normal Saline

Interventions

Standard-dose rhBMP-2 BIOLOGICAL

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.

Also known as: Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)

Standard-dose rhBMP-2

Micro-dose rhBMP-2 BIOLOGICAL

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.

Micro-dose rhBMP-2

Sterile Normal Saline DRUG

Sterile normal saline is locally applied into the implant osteotomy immediately before implant placement as the placebo control.

Placebo Control

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Dr. Mahdi Dental Clinic

Baghdad, Baghdad Governorate, 10001, Iraq

Location

MeSH Terms

Conditions

Tooth Loss

Interventions

Bone Morphogenetic Protein 2; recombinant human bone morphogenetic protein-2

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Bone Morphogenetic Proteins; TGF-beta Superfamily Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Central Study Contacts

omer Alhashimi, M.SC.

CONTACT

+9647733380409; omerdentist2@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants and postoperative care providers will be blinded to treatment allocation. Randomization codes will be concealed until completion of data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist, M.Sc. in Advanced Oral Surgery and Implantology, University of Bari Aldo Moro, Italy

Model Details: Participants will be randomly assigned in a 1:1:1 ratio to receive standard-dose rhBMP-2, micro-dose rhBMP-2, or placebo during dental implant placement. Each participant will remain in the assigned intervention group throughout the study.

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)