Post Extraction Changes Following Ridge Preservation Using Allogenis Dentin Vs Autogenous Partially Demineralized Dentin

NCT06477887 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-08-06

No results posted yet for this study

Summary

Research question:

In patients with unrestorable anterior teeth, will the use of allogenic dentin matrix be more effective than autogenous partially demineralized dentine matrix (APDDM) in reducing hard tissue changes after post-extraction ridge preservation in the aesthetic zone? After enrolment, periodontal and radiographic examinations will be conducted, and patients with badly unrestorable teeth in the aesthetic zone will be identified. These patients will undergo measurements of mesio-distal distance between adjacent teeth, corono-apical height of bone, the presence of a labial undercut, dehiscence, or fenestration, and the relationship to adjacent teeth using the transgival probing technique and a preapical radiograph, or CBCT.

In both groups, the desired tooth will be atraumatically extracted under local anaesthesia using peritomies and surgical forceps.

In the intervention group: preparation of the allogenic dentin matrix.

Steps of Allogenic Dentin Processing:

Washing with distilled water for 30-120 minutes Ultrasonic cleaning cycles: 1st with distilled water for 5-10 minutes, 2nd with 5-7% hydrogen peroxide 10-30 minutes, then 3 minutes with distilled water for 5-10 minutes at 60-80 Defatting with Chloroform Methanol Solution 1:0.5 for 3-12 hours. Demineralization with 0.5% HCL for 10-60 min Dehydration with Neutral Ethyl Alcohol for 30 minutes, then defatting with Chloroform Methanol Solution 1:0.5 for 3-12 hours Washing with normal saline and freeze-drying, then sterilisation using ethylene oxide gas.

After the recovery period of 6 months", a biopsy is taken for cases from the site of the operation for histological evaluation during implant placement.

• In the control group, the teeth will be cleaned and dried, and then the dentin will be ground to obtain particles of a certain size, which will be partially demineralized by using a tooth transformer machine. In both groups, the dentin graft will be placed inside the socket, and then a 5/0 proline suture will be used to fix the collagen membranes to cover the graft. After the recovery period of 6 months", a biopsy is taken for cases from the site of the operation for histological evaluation during implant placement.

Outcome:

Radiographic bucco-lingual ridge width loss. Radiographic palatal vertical bone changes. Radiographic buccal vertical bone changes. Percentage of new vital bone formation. Percentage of residual bone graft. Implant Primary Stability.

Conditions

  • Socket Preservation

Interventions

BIOLOGICAL

Allogeneic Dentin Matrix

Steps of Allogenic Dentin Processing: Wash with distilled water for 30-120 minutes. Ultrasonic Cleaning Cycles: 1st with distilled water for 5-10 minutes, 2nd with 5-7% hydrogen peroxide for 10-30 minutes, then the 3rd with distilled water for 5-10 minutes at 60-80. Defatting with Chloroform Methanol Solution 1:0.5 for 3-12 hours. Demineralization with 0.5N HCL for 10-60 min. Dehydration with Neutral Ethyl Alcohol for 30 minutes, then Defatting with Chloroform Methanol Solution 1:0.5 for 3-12 hours. Wash with normal saline and freeze dry, then sterilise using ethylene oxide gas. The extracted socket will be filled with allogenic dentin

BIOLOGICAL

Autogenous Partially Demineralized Dentine Matrix

The extracted tooth will be cleaned with a diamond bur under abundant irrigation with physiological water. All filling materials (gutta-percha, composite, luting cements, etc.) will be removed with the outmost care and under magnification. Subsequently, the tooth will be cut into fragments (5 × 5 mm) and inserted into the milling device (Tooth Transformer, Milan, Italy). According to the manufacturer, a disposable box containing disposable liquid solutions will be inserted into the device to ensure the demineralization of the graft with 0.1 M hydrochloric acid, 10% hydrogen peroxide, and demineralized water as a wash. After 25 minutes, particle graft biomaterials will be obtained. The particle size will range from 815 µm with peaks up to 1110 µm. The socket will be filled with the graft.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-03
Primary Completion
2024-08-31
Completion
2024-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06477887 on ClinicalTrials.gov