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

NCT05437172 | Completed

• 1 other identifier: Shaam
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Radiographic Bucco-lingual ridge width change

  radiographic measurement

  up to 24 weeks

Secondary Outcomes (5)

• Changes in the height of the socket buccal and lingual ridges.

  up to 24 weeks

• postoperative pain

  immediately after the procedure

• Patient satisfaction

  immediately after the procedure

• Keratinized tissue width

  up to 24 weeks

• chair time

  immediately after the procedure

Study Arms (2)

injectable platelet rich fibrin with deminerlized dentin graft

EXPERIMENTAL

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

Procedure: injectable platelet rich fibrin with demineralized dentin graft

deminerlized dentin graft

ACTIVE COMPARATOR

deminerlized dentin graft for ridge preservation after teeth extraction

Procedure: demineralized dentin graft

Interventions

injectable platelet rich fibrin with demineralized dentin graft 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.

injectable platelet rich fibrin with deminerlized dentin graft

demineralized dentin graft 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.

deminerlized dentin graft

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Manial, 12311, Egypt

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Odai A Hwafdeh, BDS

  Master student

  PRINCIPAL INVESTIGATOR

• Nesma M Shemais, PhD

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

  STUDY DIRECTOR

• Mona S Darhous, PhD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 29, 2022
• Study Start: June 30, 2022
• Primary Completion: July 1, 2023
• Study Completion: December 15, 2023
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

EG (1)