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Completed

NCT Number: NCT05437172

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

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.

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Key information

Conditions

Ridge Preservation Alveolar Bone Loss Bone Diseases Bone Resorption Dentin Graft Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

Cairo, Manial, 12311, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Radiographic Bucco-lingual ridge width change

    Time frame: up to 24 weeks

    radiographic measurement

Secondary outcomes

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

    Time frame: up to 24 weeks

    radiographic measurement

  2. postoperative pain

    Time frame: immediately after the procedure

    Visual analogue scale from zero (better) to 10 (worse)

  3. Patient satisfaction

    Time frame: immediately after the procedure

    binary yes and no

  4. Keratinized tissue width

    Time frame: up to 24 weeks

    periodontal probe measurement

  5. chair time

    Time frame: immediately after the procedure

    in minutes

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 29, 2022
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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