Evaluation of Dentin Graft and I-PRF With and Without Vitamin C for Post-extraction Socket Preservation

NCT06569264 | Recruiting

• 1 other identifier: noha93
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate radiographic ridge width change following autogenous demineralized dentin graft (ADDG) and i-PRF addition with and without vitamin C (AA) for post extraction socket preservation. The main question is: In patient with non-restorable teeth, does adding vitamin C to dentin graft and i-PRF affect the radiographic ridge width of post extraction sockets? Intervention group: Alveolar ridge preservation using vitamin C (AA) with autogenous demineralized dentin graft combined with i-PRF. Adding vitamin C to dentin graft and i-PRF might aid in reducing the dimensional changes, since it increases osteoblast proliferation and viability during socket preservation. Layers of osteoblast cell morphology can be seen at day 11 with the presence of 25mM of vitamin C. By adding vitamin C to i-PRF we can add the advantages of improving soft tissue quality as well. Control group: Alveolar ridge preservation using autogenous demineralized denting graft combined with i-PRF. Dentin particle can be used as an excellent autogenous graft material to replace other autogenous graft materials, it can be used in socket preservation. as it enhances bone formation, and has shown an ability to maintain the alveolar ridge dimensions because of its osteo-conductive properties. Moreover, dentin graft is used as a cost-effective grafting material during socket preservation. The initial therapy consists of periodontal treatment (phase I therapy) including supragingival scaling, subgingival debridement if needed, adjustment of faulty restoration and polishing. The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques. Flapless and atraumatic tooth extraction will be initiated, Then the sockets will be carefully packed with the allocated graft material that are shaped to match the individual size and contours of each socket. Once the grafts are properly adapted to the sockets, they will be covered with the corresponding graft material, and an absorbable gelatin sponge (gelfoam) will be used for socket and graft material coverage and secured using an internal crisscross knot using 5-0 monofilament polypropylene suture material.

Conditions

Socket Preservation

Keywords

Socket preservation; Ridge preservation; Demineralized autogenous dentin graft; i-PRF; vitamin C; ascorbic acid

Outcome Measures

Primary Outcomes (1)

• Radiographic ridge width change

  To ensure the primary outcome directly reflects the biological effect of socket preservation and to avoid confounding introduced by implant surgery and loading, the primary outcome has been refined to radiographic horizontal ridge width change measured at baseline and follow-up timepoints. The difference from baseline to 3 months follow-up in the radiographic bucco palatal ridge width. CBCT scans will be performed at baseline and 3 months postoperatively. Measurements will be taken at both time points using identical reference points and lines measured at a level of 2 mm below the most coronal cross section and perpendicular to the vertical reference line

  3 months

Secondary Outcomes (5)

• Buccal ridge height

  3 months

• Lingual ridge height

  3 months

• Percentage of newly formed bone

  after 3 months postoperatively.

• Histological evaluation of residual graft in human biopsies

  after 3 months postoperatively.

• postoperative pain

  2 weeks, 1 month and 3 months

Study Arms (2)

Alveolar ridge preservation using vitamin C with dentin graft and i-PRF

EXPERIMENTAL

Pure vitamin C will be added and extraction socket will be filled with the corresponding graft material. Adding vitamin C to dentin graft and i-PRF might aid in reducing the dimensional changes and marginal bone loss, since it increases osteoblast proliferation and viability during socket preservation. Layers of osteoblast cell morphology can be seen at day 11 with the presence of 25mM of vitamin C. By adding vitamin C to i-PRF we can add the advantages of improving soft tissue quality as well.

Procedure: Alveolar ridge preservation using vitamin C with dentin graft and i-PRF

Alveolar ridge preservation using autogenous demineralized denting graft combined with i-PRF.

ACTIVE COMPARATOR

Autogenous demineralized dentin graft combined with i-PRF and extraction socket will be filled with the corresponding graft material. This mix provided promising clinical outcomes and considered an ideal bioactive graft material for hard tissue regeneration. Autogenous particulate dentin and platelet rich fibrin mix assist healing and counteract pronounced resorption of alveolar process.It can be used as an excellent autogenous graft material to replace other autogenous graft materials, and has shown an ability to maintain the alveolar ridge dimensions because of its osteo-conductive properties. Moreover, dentin graft is used as a cost-effective grafting material during socket preservation.

Procedure: Alveolar ridge preservation using autogenous demineralized dentin graft and i-PRF

Interventions

Alveolar ridge preservation using autogenous demineralized dentin graft and i-PRF PROCEDURE

Flapless atraumatic extraction. After thorough mechanical cleaning, the sockets will be rinsed with 5 ml of an aqueous 0.125% chlorhexidine digluconate solution, followed by a 5 ml sterile saline rinse to remove tissue debris from the socket. Followed by inspection of extraction socket integrity, using a William's graduated periodontal probe. Extracted teeth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries or restorations using a high-speed fine finishing stone and saline irrigation. The pulp chamber will be cleaned with sterile endodontic files. Teeth will be ground, using hand bone mill. The (ADDG) particles prepared by demineralization of tooth particles in 0.6N hydrochloric acid for 30 min to achieve demineralized then washed twice in saline and dried with sterile gauze. The ADDG will be collected in a sterile plastic syringe. For the preparation of i-PRF, 10 mL of venous blood will be drawn into a PET tube and centrifuged at 700rpm for 3 min.

Alveolar ridge preservation using autogenous demineralized denting graft combined with i-PRF.

Alveolar ridge preservation using vitamin C with dentin graft and i-PRF PROCEDURE

Flapless atraumatic extraction. After thorough mechanical cleaning, the sockets will be rinsed with 5 ml of an aqueous 0.125% chlorhexidine digluconate solution, followed by a 5 ml sterile saline rinse to remove tissue debris from the socket. The ADDG particles will be collected in a sterile plastic syringe. For the preparation of i-PRF, 10 mL of venous blood will be drawn into a sterile PET tube and centrifuged at 700 rpm for 3 minutes. The resulting i-PRF liquid layer will then be aspirated from the top of the tube and transferred into the syringe containing the ADDG particles. 25 mM of pure vitamin C , drawn using a micropipette, will be aspirated into the same syringe containing the ADDG-i-PRF mixture. The combined mixture will then be allowed to set for 10 minutes to produce the sticky ADDG.

Alveolar ridge preservation using vitamin C with dentin graft and i-PRF

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years of age.
• Single extraction of non-molar teeth with periodontally healthy adjacent teeth.
• Non-contributory medial history.
• Non- restorable teeth indicated for extraction.
• Requiring alveolar preservation after tooth extraction prior to placement of dental implant.
• Participants that are eligible for immediate implantation, yet having factors that are hindering these patients from immediate placement of an implant at the time of extraction (ex: Financial related factors - psychological psychological factors - time related factors).
• Cooperative patients who are willing to commit for 3 months follow up.

You may not qualify if:

• Pregnant female.
• Acute infection at extraction site.
• Systemic conditions affecting healing (e.g., diabetes, medications as bisphosphonates...)
• A participant who had radiotherapy or chemotherapy.
• Psychiatric patient, or with a learning disability, or unable to give consent.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

proliferation regulatory factors, human urine

Study Officials

• Karim fawzy, Professor

  Cairo University

  STUDY DIRECTOR

• Nesma Shemais, Lecturer

  Cairo University

  STUDY CHAIR

• Noha Barwa, Bachelor

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noha A Barwa, Bachelor

CONTACT

+201116010759; noha.ahmed@dentistry.cu.edu.eg

Nesma Shemais, Lecturer

CONTACT

nesma.shemais@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator Noha Barwa Master degree student, faculty of dentistry, Cairo University

Model Details: A randomized clinical trial

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 26, 2024
• Study Start: November 4, 2025
• Primary Completion: February 15, 2026
• Study Completion: February 28, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

EG (1)