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

NCT ID: NCT06031298

Last Updated: 2025-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Dentin Graft, Alveolar Ridge Preservation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Alveolar ridge preservation using demineralized dentin graft at 12 weeks.

Group Type EXPERIMENTAL

Dentin Graft

Intervention Type BIOLOGICAL

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

Alveolar ridge preservation using demineralized dentin graft at 18 weeks

Group Type ACTIVE_COMPARATOR

Dentin Graft

Intervention Type BIOLOGICAL

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

Alveolar ridge preservation using demineralized dentin graft at 24 weeks

Group Type ACTIVE_COMPARATOR

Dentin Graft

Intervention Type BIOLOGICAL

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

Interventions

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Dentin Graft

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ahmed Mohamed

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry - Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed A Mohamed

Role: CONTACT

+201224005098

Other Identifiers

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FDASU-REC 1254

Identifier Type: -

Identifier Source: org_study_id

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