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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06031298
Enrollment
30
Registered
2023-09-11
Start date
2023-11-01
Completion date
2026-01-01
Last updated
2025-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentin Graft, Alveolar Ridge Preservation

Brief summary

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.

Interventions

BIOLOGICALDentin Graft

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Radiographic AssessmentBaseline, 12, 18 & 24 monthsRadiographic dimensional changes of the alveolar ridge following ARP using CBCT

Secondary

MeasureTime frameDescription
Implant primary stabilityTime of implant placement at each groupImplant primary stability using Ostell device
Histological AssessmentCore biopsy obtained at 12, 18 and 24 weeks for the different groups.Histomorphometric analysis.

Countries

Egypt

Contacts

Primary ContactMohamed A Mohamed
mohamed.mostafa@miuegypt.edu.eg+201224005098

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026