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

Clinical and Radiographic Evaluation of Autogenous Demineralized Dentin Graft for Ridge Preservation With and Without Injectable Platelet Rich Fibrin (A Randomized Controlled Clinical Trial)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alveolar Bone Loss; Ridge Preservation; Dentin Graft
• Intervention / Treatment: Procedure: injectable platelet rich fibrin with demineralized dentin graft; Procedure: demineralized dentin graft

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Odai A Hwafdeh, BDS; Phone Number: 00201225748102; Email: odai.amer@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Manial
    • Cairo, Manial, Egypt, 12311
      • Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: injectable platelet rich fibrin with deminerlized dentin graft; injectable platelet rich fibrin with deminerlized dentin graft for ridge preservation after teeth extraction	Procedure: 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.
Active Comparator: deminerlized dentin graft; deminerlized dentin graft for ridge preservation after teeth extraction	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Bucco-lingual ridge width change	radiographic measurement	up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the height of the socket buccal and lingual ridges.	radiographic measurement	up to 24 weeks
postoperative pain	Visual analogue scale from zero (better) to 10 (worse)	immediately after the procedure
Patient satisfaction	binary yes and no	immediately after the procedure
Keratinized tissue width	periodontal probe measurement	up to 24 weeks
chair time	in minutes	immediately after the procedure

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Odai A Hwafdeh, BDS, Master student; Study Director: Nesma M Shemais, PhD, Lecturer of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University; Study Chair: Mona S Darhous, PhD, Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Actual): July 1, 2023
• Study Completion (Estimated): December 15, 2023

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: Shaam

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No