Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06552793

Evaluation of Post Extraction Hard Tissue Alteration Following Ridge Preservation In The Esthetic Zone Using Partially Demineralized Autogenous Dentine Graft Versus Xenograft: A Randomized Controlled Clinical Trial.

Led by Cairo University · Updated on 2024-08-14

23

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the differences between using a partially demineralized autogenous dentin graft and a xenograft in bone regeneration after tooth extraction in the esthetic zone. The study focuses on clinical, radiographic, and histomorphometric outcomes related to alveolar ridge preservation in patients requiring extraction of non-restorable teeth. This research aims to compare the effects of these two graft materials on hard tissue changes following extraction and ridge preservation procedures. Participants will undergo initial periodontal therapy including cleaning and polishing, followed by atraumatic tooth extraction. The sockets will be filled with either the autogenous dentin graft prepared by a specialized device or a bovine xenograft, both covered with a collagen membrane secured by sutures. The study includes a test group receiving the dentin graft and a control group receiving the xenograft. After six months, bone biopsies and implant placements will be performed to evaluate the healing and regenerative outcomes. Participants will be assessed before surgery, immediately after, and six months post-surgery using clinical parameters and cone-beam CT scans to measure horizontal ridge width and ridge height changes. Histological analysis will determine new bone formation and residual graft presence. Implant primary stability will also be evaluated. Postoperative care includes antibiotics, pain management, oral hygiene instructions, and suture removal after two weeks. The total follow-up period for each participant is six months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with non-restorable teeth and Type II extraction socket in the esthetic zone indicated for extraction due to periodontal, carious, or traumatic reasons.
  • Healthy patients with adequate oral hygiene (bleeding on probing 60%; Plaque index 60%).
  • Adults 18 years old and above.
  • Patients willing to accept a 6-month follow-up period and provide informed consent.
Not Eligible

You will not qualify if you...

  • Heavy smokers (more than 10 cigarettes per day or using e-cigarettes with nicotine dose >6 mg/ml).
  • Patients with systemic conditions that may affect healing or bone metabolism (e.g., diabetes).
  • Patients with poor oral hygiene (bleeding on probing >20%; Plaque index >20%).
  • Presence of acute periapical infection.
  • Presence of severe periodontal destruction.

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day procedure with 2 weeks of postoperative care

Participants undergo atraumatic tooth extraction followed by alveolar ridge preservation using either an autogenous partially demineralized dentin graft or a xenograft. This includes socket cleaning, graft placement, collagen membrane coverage, and suturing.

1 surgery visit and suture removal visit after 2 weeks

Follow-up

Duration - 6 months

Participants receive postoperative care instructions, prescribed medications, and are monitored with CBCT scans on the first day after surgery and at 6 months. At 6 months, a bone biopsy and implant placement are performed under local anesthesia.

1 baseline CBCT visit, 1 suture removal visit, 1 final CBCT visit, and 1 implant placement visit

Trial Site Locations

Total: 1 location

1

Faculty of Dentistry Cairo University

Cairo, Egypt

Actively Recruiting

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Research Team

R

Riham A Alshikh Hani Alkurdee, Bachelor

W

Weam El-Battawy, Ass. Prof.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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