Alveolar Ridge Preservation Using Collagen Material and Allograft

NCT04321109 | Completed DMC

• 1 other identifier: FDASU-RECD 071402
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

Seven Patients who need implants to replace non-restorable teeth in the esthetic zone. Intervention Group (1): Seven extraction sockets that received the collagen matrix (Collagen cone) for alveolar ridge preservation. Comparison Group (2): Seven extraction sockets that were treated with mineralized cortico-cancellous bone allograft for alveolar ridge preservation. Outcome

• The height of alveolar ridge was assessed clinically using a periodontal probe.
• The width of the alveolar ridge was measured after three months after extraction using a caliper clamp.
• Changes in the width and height of alveolar bone were evaluated in merged axial and sagittal views using the I-CAT superimposition system (CBCT). 2- Evaluation of newly formed bone quality was performed by histological examination and histomorphometric analysis. 3- Immuno-histochemical staining was done using polyclonal antibody to detect (BMP-2) marker of bone formation

Conditions

Alveolar Ridge Preservation

Keywords

Alveolar ridge preservation; Allograft; Collagen cone

Outcome Measures

Primary Outcomes (1)

• clinical score

  Dimensional changes in alveolar ridge after alveolar ridge preservation both clinically and radiographically

  change from baseline at 12 weeks

Secondary Outcomes (1)

• BMP-2

  detected at 12 weeks

Study Arms (2)

Collagen cone

EXPERIMENTAL

Collagen matrix

Other: Collagen cone

Allograft

ACTIVE COMPARATOR

mineralized corticocancellous allograft

Other: Allograft

Interventions

Allograft OTHER

Corticocancellous mineralized allograft

Allograft

Collagen cone OTHER

Collagen matrix

Collagen cone

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients were medically free .
• Two teeth indicated for extraction due to either severe decay, tooth fracture or failed endodontic treatment.

You may not qualify if:

• Patients with poor oral hygiene or not willing to perform oral hygiene measures.
• Pregnant and breast-feeding females.
• Smokers , Teeth with periodontal or periapical infections.
• Patients with malocclusion.
• All patients who had known contraindication to dental implant surgery (e.g: bleeding tendency, radiotherapy, taking bisphosphonate)

Sponsors & Collaborators

• Yasmine Fouad: lead

MeSH Terms

Interventions

Transplantation, Homologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Hala A Abuel-Ela, Professor

  Faculty of Dentistry Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Results were sent to Outcome Assessor masked , so he was not able to know results belong to which group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer of oral medicine and periodontology

Model Details: Group (1): Seven extraction sockets that received the collagen matrix (Collacone) for alveolar ridge preservation. Group (2): Seven extraction sockets that were treated with mineralized cortico-cancellous bone allograft (Maxgraft) for alveolar ridge preservation

Study Record Dates

• First Submitted: March 22, 2020
• First Posted: March 25, 2020
• Study Start: June 2, 2016
• Primary Completion: March 21, 2018
• Study Completion: March 21, 2018
• Last Updated: September 23, 2022

Record last verified: 2022-09