Efficacy of Antiresorptive and Bone Forming Material on Dental Implants

NCT04140006 | Unknown Phase 1

• 1 other identifier: 034118
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Insertion of a metal implant is considered one of the most common surgeries for fracture treatment, joint replacement, and dental implants. The success rate of these implants depends on their fixation which is in turn related primarily on the strength of the bone holding them. Studies evaluating the influence of local application of antiresorptive drugs, like bisphosphonates, on implanted endoprostheses whether orthopedic or dental is increasing annually with more and more experimental studies as well as clinical trials worldwide. On the other hand implants that release medications that enhance bone formation will lead to improved implant fixation and success. The objective of this study was to evaluate the effect of topical application of alendronate sodium gel and recombinant human bone morphogenic protein 2 on dental implant stability and crestal bone level.

Conditions

Partial Edentulism

Outcome Measures

Primary Outcomes (5)

• Implant stability

  Mean implant stability between different comparators following implants insertion by using resonance frequency analysis scaled from 1 to 100

  8 weeks

• Implant stability

  Mean implant stability between different comparators following implants insertion by using resonance frequency analysis scaled from 1 to 100

  12 weeks post surgery

• Implant stability

  Mean implant stability between different comparators following implants loading by using resonance frequency analysis scaled from 1 to 100

  12 weeks post loading

• Crestal bone level

  Mean crestal bone level between different comparators following implants insertion by using cone beam computerized tomography measured from the first bone implant contact by millimeters

  12 weeks post surgery

• Crestal bone level

  Mean crestal bone level between different comparators following implants loading by using cone beam computerized tomography measured from the first bone implant contact by millimeters

  12 weeks post loading

Secondary Outcomes (2)

• Bone density around dental implant

  12 weeks post surgery

• Bone density around dental implant

  12 weeks post loading

Study Arms (4)

Alendronate Gel (ALN)

ACTIVE COMPARATOR

After preparation, 0.05 ml of the gel containing 100 µg of ALN will be injected in the osteotomy site immediately before fixture insertion (20 fixtures)

Drug: ALN Gel

Bone Morphogenic Protein Gel (BMP)

ACTIVE COMPARATOR

After preparation, 0.05 ml of the gel containing 100 µg of BMP will be injected in the osteotomy site immediately before fixture insertion (20 fixtures)

Drug: BMP Gel

Mixture Gel of ALN and BMP

ACTIVE COMPARATOR

After preparation, 0.05 ml of mixture gel containing 50 µg of ALN and 50 µg of BMP will be injected in the osteotomy site immediately before fixture insertion (20 fixtures)

Drug: Mixed Gel

Control

SHAM COMPARATOR

After preparation, the fixture will be inserted without topical application of any medication (20 fixtures)

Drug: Control

Interventions

ALN Gel DRUG

Flapped surgery for insertion of dental implant with topical application of ALN gel

Also known as: Alendronate Sodium trihydrate, m.w 325.12, Pharmaceutical Secondary standard, PHR 1599

Alendronate Gel (ALN)

BMP Gel DRUG

Flapped surgery for insertion of dental implant with topical application of BMP gel

Also known as: CowellBMP, recombinant human bone morphogenic protein type 2, rhBMP2

Bone Morphogenic Protein Gel (BMP)

Mixed Gel DRUG

Flapped surgery for insertion of dental implant with topical application of mixed gel of ALN and BMP

Also known as: Mixture of Alendronate Sodium trihydrate, m.w 325.12, Pharmaceutical Secondary standard, PHR 1599, and CowellBMP, recombinant human bone morphogenic protein type 2, rhBMP2

Mixture Gel of ALN and BMP

Control DRUG

Flapped surgery for insertion of dental implant without topical application of any gel

Also known as: No treatment

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

College of dentistry, University of Baghdad

Baghdad, Bab-Almoadham, 1417, Iraq

Location

MeSH Terms

Interventions

Bone Morphogenetic Protein 2

Intervention Hierarchy (Ancestors)

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

Study Officials

• Salwan Y Bede

  University of Baghdad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: October 25, 2019
• Study Start: July 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)