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NCT Number: NCT06031298

Influence of Various Healing Intervals on Alveolar Ridge Preservation Using Demineralized Dentin Graft: A Randomized Clinical Trial

Statement of the problem:

The alveolar ridge undergoes various remodeling processes following tooth extraction, but the ridge resorption continues over time, resulting in hard and soft tissue loss which complicates prosthodontic rehabilitation whether by dental implants or tooth supported prosthesis.

Aim of the study:

The aim of the study is to assess the influence of the different time intervals on the healing of the demineralized dentin graft in alveolar ridge preservation (ARP) procedures.

Materials and methods:

30 patients with hopeless teeth requiring extraction in maxillary non molar areas and requiring replacement with dental implants, will be enrolled and recruited from the outpatient clinic, faculty of dentistry, ain shams university according to the inclusion criteria. They will be randomly allocated into three equal groups. Group A (n=10) alveolar ridge preservation will be done with demineralized dentin graft and re-entry at 12 weeks, group B (n=10) alveolar ridge preservation will be done with demineralized dentin graft and re-entry at 18 weeks and group C (n=10) alveolar ridge preservation will be done with demineralized dentin graft and re-entry at 24 weeks. Radiographic assessment will be done using CBCT to the arch of interest and another cone beam will be done prior to the implant placement at 11, 17 and 23 weeks based on the study group and a volumetric assessment will be done with digital subtraction. At the respective times core biopsy will be taken for the histological assessment, and the implant placement will be done with the implant primary stability recorded using Ostell. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed. Data collected will be tabulated and statistically analyzed.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Dentistry - Ain Shams University

Cairo, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Systemically free patients (American Society of Anesthesiologists I; ASA I)
  • Age range 20 - 50.
  • Non-molar maxillary teeth indicated for extraction.
  • Patients with extraction sockets having intact bony walls, or no more than one bony wall dehiscence not extending more than 50% of the total bone height

Exclusion criteria

  • Teeth to be extracted or adjacent teeth associated with acute infections.
  • Smokers.
  • Patients with other conditions that may affect the treatment [uncontrolled diabetes mellitus (HbA1c >7.0), liver or kidney failure, any active oral or systemic acute infections, currently receiving chemo-or radiotherapy or a history of radiotherapy in the head and neck area, severe hematologic disorders].
  • Pregnant and lactating females.
  • Patients with history of lack of compliance to dental visits and unwillingness or inability to sign the informed consent.

Treatment and study plan

Dentin Graft

Biological

Dentin graft is a grafting technique of autogenous origin that uses the teeth extracted from the patient for the graft material preparation.

Primary outcomes

  1. Radiographic Assessment

    Time frame: Baseline, 12, 18 & 24 months

    Radiographic dimensional changes of the alveolar ridge following ARP using CBCT

Secondary outcomes

  1. Implant primary stability

    Time frame: Time of implant placement at each group

    Implant primary stability using Ostell device

  2. Histological Assessment

    Time frame: Core biopsy obtained at 12, 18 and 24 weeks for the different groups.

    Histomorphometric analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed A Mohamed

CONTACT

[email protected]

+201224005098

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 11, 2023
Registry last updated
Jan 31, 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.