Post Extraction Alterations Following Ridge Preservation In The Esthetic Zone Using Partially Demineralized Autogenous Dentine Graft Versus Xenograft

NCT06552793 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-08-14

No results posted yet for this study

Summary

the aim of this study is to establish if there are clinical, radio-graphical and histomorphometrical differences between using Partially Demineralized Dentin graft versus Xenograft in the esthetic zone. as a clinical application in alveolar bone regeneration procedures related to implant dentistry, including socket preservation, alveolar ridge augmentation, after tooth extraction in the esthetic zone. After extraction of non-restorable teeth in the esthetic zone, will ridge preservation with application of partially demineralized autogenous dentin graft produce less hard tissue changes compared to xenograft?

The initial therapy consists of periodontal treatment (phase I therapy) including supragingival scaling, subgingival debridement if needed, adjustment of faulty restoration and polishing. The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques. Flapless and atraumatic tooth extraction will be initiated, Then the sockets will be carefully packed with the allocated graft material that are shaped to match the individual size and contours of each socket. Once the grafts are properly adapted to the sockets, they will be covered with collagen membrane. The membrane will be shaped to extend 2-3 mm beyond the margins of the extraction socket and positioned just beneath the marginal mucosa. To ensure its stability, a cross-suture will be performed, securing the membrane in place.

Intervention group: The socket will be filled with partially demineralized autogenous dentin graft Control group: The socket will be filled with xenograft . For both groups, All the subjects will be evaluated at pre-surgical, baseline and 6 months post surgical months for clinical parameters and baseline( immediate post-surgical and 6 months post-surgical . Outcomes: Change in radiographic horizontal ridge width at 1mm below the most coronal aspect of the crest , Change in radiographic horizontal ridge width at 3 and 5mm below the most coronal aspect of the crest,Change in radiographic buccal ridge height , Change in radiographic buccal ridge height ,Change in radiographic Palatal ridge height,Percentage of new vital bone formation,Percentage of residual bone graft,Implant Primary Stability.

Detailed Description: This study aims to evaluate clinical, radiographic and histomorphometrica

Conditions

  • Socket Preservation

Interventions

BIOLOGICAL

autogenous partially demineralized dentin graft

tooth cleaning : form decay, tartar, soft tissue debris, fillings, cement then cut into fragments (5×5 mm) and inserted into the milling device (Tooth Transformer, Milan, Italy). 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.The decontamination of the granules will take place through UVA rays and ultrasounds, with temperature variations always lower than 43 ◦C to avoid damage to proteins. After 25 min, particle graft biomaterials will be obtained. The particles size will range from 815 µm with peaks up to 1110 µm.

BIOLOGICAL

Xenograft

Cortico-cancallous Bovine powder

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Manal M Hosny, Professor · Cairo University

  • Weam A El-Battawy, Ass. Prof. · Cairo University

  • Riham A Alshikh Hani Alkurdee, Bachelor · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2024-09-01
Completion
2025-02-01

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 NCT06552793 on ClinicalTrials.gov