Evaluation of Autogenous Demineralized Dentin Graft for Ridge Preservation With and Without Injectable Platelet Rich Fibrin

NCT ID: NCT05437172

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2023-12-15

Brief Summary

Ridge preservation should be considered whenever possible after tooth extraction. Whether implant placement would be performed or for aesthetic consideration at pontic sites when conventional bridge is planned. Ridge preservation aims to maximize the bone formation accompanied with good soft tissue architecture to facilitate implant and prosthetic replacement restoring function, phonetics and aesthetics. the Aim of the study is To evaluate the bucco-lingual ridge width clinically and radiographically, height of buccal and lingual ridges of the socket after application of injectable platelet rich fibrin and autogenous dentin graft.

Conditions

Ridge Preservation; Alveolar Bone Loss; Dentin Graft

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

injectable platelet rich fibrin with deminerlized dentin graft

injectable platelet rich fibrin with deminerlized dentin graft for ridge preservation after teeth extraction

Group Type: EXPERIMENTAL

injectable platelet rich fibrin with demineralized dentin graft

Intervention Type: PROCEDURE

after atraumatic extraction, collection of whole venous blood (9 ml) in sterile vacutainer tubes will be done without anticoagulant added, vacutainer tubes will be then placed in a centrifugal machine at 700 revolutions per minute (rpm) for 3 min with a tube filled with water to maintain the balance during the centrifuging process. ADDG particles prepared by demineralization of tooth particles in 0.6N hydrochloric acid for 30 min to achieve demineralization then washed twice in saline and dried with sterile gauze. Graft particles will be loaded at the defect site to restore ridge form, large metal condenser was used to adapt the graft to the defect and stabilizing the graft with sutures.

deminerlized dentin graft

deminerlized dentin graft for ridge preservation after teeth extraction

Group Type: ACTIVE_COMPARATOR

demineralized dentin graft

Intervention Type: PROCEDURE

after atraumatic extraction, ADDG particles will be prepared by demineralization of tooth particles in 0.6N hydrochloric acid for 30 min to achieve demineralization then washed twice in saline and dried with sterile gauze.

Graft particles will be loaded at the defect site to restore ridge form, large metal condenser was used to adapt the graft to the defect and stabilizing the graft with sutures.

Interventions

injectable platelet rich fibrin with demineralized dentin graft

after atraumatic extraction, collection of whole venous blood (9 ml) in sterile vacutainer tubes will be done without anticoagulant added, vacutainer tubes will be then placed in a centrifugal machine at 700 revolutions per minute (rpm) for 3 min with a tube filled with water to maintain the balance during the centrifuging process. ADDG particles prepared by demineralization of tooth particles in 0.6N hydrochloric acid for 30 min to achieve demineralization then washed twice in saline and dried with sterile gauze. Graft particles will be loaded at the defect site to restore ridge form, large metal condenser was used to adapt the graft to the defect and stabilizing the graft with sutures.

Intervention Type: PROCEDURE

demineralized dentin graft

after atraumatic extraction, ADDG particles will be prepared by demineralization of tooth particles in 0.6N hydrochloric acid for 30 min to achieve demineralization then washed twice in saline and dried with sterile gauze.

Graft particles will be loaded at the defect site to restore ridge form, large metal condenser was used to adapt the graft to the defect and stabilizing the graft with sutures.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years need of at least one single rooted tooth extraction.
• Non-restorable teeth.
• Systemically healthy patients.
• Good oral hygiene, Plaque index less than 15%.
• Non-smoker or Smoking ≤ 10 cigarettes/day.
• Cooperative patients able and accept to come for follow up appointments.

Exclusion Criteria

• Any interim intervention that may have affected any of the outcomes of interest.
• Pregnant and lactation females.
• Smoking ˃ 10 cigarettes/day.
• Patients reporting systemic conditions that may compromise healing or bone metabolism (eg: diabetes).
• Patients with poor oral hygiene.
• Any known allergies.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Odai Amer Ahmad Hwafdeh

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Odai A Hwafdeh, BDS

Role: PRINCIPAL_INVESTIGATOR

Master student

Nesma M Shemais, PhD

Role: STUDY_DIRECTOR

Lecturer of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University

Mona S Darhous, PhD

Role: STUDY_CHAIR

Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University

Locations

Faculty of Dentistry, Cairo University

Cairo, Manial, Egypt

Countries

Egypt

Other Identifiers

Shaam

Identifier Type: -

Identifier Source: org_study_id