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

NCT06477887 | Recruiting

• 1 other identifier: 14128
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Socket Preservation; Allogenic Dentin Matrix; Autogenous Partially Demineralized Dentine Matrix

Outcome Measures

Primary Outcomes (1)

• Radiographic bucco-lingual ridge width loss

  Baseline and 6-month postoperative CBCT scans will be conducted. At both time points, measurements will be taken with identical reference points and lines. Matched cuts of baseline and final scans were obtained at the mesio-distal centres of extraction sites, and both cuts were superimposed with the same dental reference for standardised measurements. A bisecting vertical reference line corresponding to the long axis of the alveolar ridge was placed in the centre of the extraction socket, and perpendicular horizontal reference lines were set at the most apical point of the extraction site. The BLRW was measured at a level of 2 mm below the most coronal cross section and perpendicular to the vertical reference. line, and both BRH and LRH were measured parallel to the vertical reference line from the most coronal crest points each to the horizontal reference line. Participant-level analysis metric: change from the baseline.

  after 6 months of the surgery

Secondary Outcomes (3)

• Change in the radiographic vertical bone level

  after 6 months of the surgery

• Percentage of new vital bone formation and residual graft:

  after 6 months of the surgery

• Implant Primary Stability

  after 6 months of the surgery

Study Arms (2)

Allogeneic Dentin Matrix

EXPERIMENTAL

Steps of Allogenic Dentin Processing: 1. Wash with distilled water for 30-120 minutes. 2. 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. 3. Defatting with Chloroform Methanol Solution 1:0.5 for 3-12 hours. 4. Demineralization with 0.5N HCL for 10-60 min. 5. Dehydration with Neutral Ethyl Alcohol for 30 minutes, then Defatting with Chloroform Methanol Solution 1:0.5 for 3-12 hours. 6. Wash with normal saline and freeze dry, then sterilise using ethylene oxide gas. The extracted socket will be filled with allogenic dentin.

Biological: Allogeneic Dentin Matrix

Autogenous Partially Demineralized Dentine Matrix

ACTIVE COMPARATOR

The extracted tooth will undergo grinding using the tooth transformer device. The produced dentin graft will be of a particle size of 400-800 μm. The extracted socket will be filled with partially demineralized autogenous dentin graft covered by a collagen membrane.

Biological: Autogenous Partially Demineralized Dentine Matrix

Interventions

Allogeneic Dentin Matrix BIOLOGICAL

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

Allogeneic Dentin Matrix

Autogenous Partially Demineralized Dentine Matrix BIOLOGICAL

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.

Autogenous Partially Demineralized Dentine Matrix

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with good health status (ASA-1, ASA-2).
• Adult patients over 18 years old.
• Patients with non-restorable teeth in the aesthetic zone for periodontal, carious, or traumatic reasons.
• Extraction socket with no more than 50% buccal bone loss.
• Patients accept a 6-month follow-up period (cooperative patients).
• Patients provide informed consent.

You may not qualify if:

• Patients reporting systemic conditions that may compromise healing (e.g., uncontrolled diabetes).
• Patients with poor maintenance of oral hygiene.
• Pregnancy.
• Smokers.
• Patients taking any medications that could compromise healing.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Cairo, Elmanil, Egypt, 4240101, Egypt

RECRUITING

Central Study Contacts

Abdullah Matar

CONTACT

01203333038; dr.@bood@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Princible Investigator, Master Degree Student, Periodontology Department, Faculty of Dentistry, Cario University

Model Details: A Randomized ControlledTrial

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 27, 2024
• Study Start: June 3, 2024
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

EG (1)