BMP Effect on Implant Stability and Marginal Bone Level After Immediate Placement

Aya Adil Saeed

Status: Active, not recruiting

Conditions: Unrestorable Tooth Replaced by Immediate Implant With BMP

Treatments: Device: conventional immediate implant; Biological: rhBMP-2 placement

Study type: Interventional

Funder types: Other

Identifiers

NCT07240493

991124

Details and patient eligibility

About

This randomized controlled clinical trial aims to evaluate the effect of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) on the stability and marginal bone level of dental implants following immediate placement.

patients requiring extraction of unrestorable tooth in upper incisors or premolar region will be randomly assigned into two groups: the experimental group will receive immediate implant placement with rhBMP-2 application, while the control group will receive immediate implant placement without rhBMP-2.

each group includes 16 immediate implants. Implant stability will be assessed using resonance frequency analysis (RFA) at baseline, and 16 weeks after implant placement. Marginal bone level changes will be evaluated radiographically using cone beam computed tomography (CBCT).

The study aims to determine whether the use of rhBMP-2 enhances osseointegration and reduces marginal bone loss compared with conventional immediate implant placement.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Healthy patients ≥18 years of either sex, having a single or multiple unrestorable maxillary anterior and premolar teeth which are indicated for extraction, where a jumping gap is most likely to form (≥2mm) provides a reliable environment to study the local effects of rhBMP-2 in consistent and replicable conditions.

  2. Apical bone ≥ 3mm from the vertical structure showed in x-rays beyond the apex.

  3. Patients who are willing to comply the study and agree to provide their consent.

  4. Good to fair oral hygiene.

Exclusion criteria

- 1. Active infection or inflammation in implant area. 2. Medically compromised patients such as uncontrolled diabetes, coagulation disorders, immune compromised patient, patient treated with bisphosphate drugs, psychiatric problems, pregnant women, or any medical condition that affect bone healing.

3. Clinical evidence of parafunctional habits. 4. Heavy smokers (≥20 cigarettes a day).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Experimental: rhBMP-2 Group

Experimental group

Description:

Immediate dental implant placement with application of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) with bone graft in jumping gap.

Treatment:

Biological: rhBMP-2 placement

Control: standard immediate implant

Active Comparator group

Description:

Standard immediate dental implant placement procedure without application of Bone Morphogenetic Protein.

Treatment:

Device: conventional immediate implant