Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID07242313

Comparative Study Between Demineralized and Mineralized Allogeneic Dentin Grafts for Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial

Led by Kafrelsheikh University · Updated on 2025-11-24

45

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

K

Kafrelsheikh University

Lead Sponsor

N

National Research Centre, Egypt

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating how two types of allogeneic dentin grafts—demineralized and mineralized—affect bone preservation after the extraction of a single upper back tooth. This trial involves 45 patients divided into three groups: one with no graft for natural healing, one using a demineralized dentin graft, and one using a mineralized dentin graft. The study aims to provide evidence to help dentists choose the best grafting approach for preserving the alveolar ridge before implant placement. The treatments involve placing the graft material into the tooth socket immediately after an atraumatic extraction. The demineralized graft is a collagen-rich matrix exposing growth factors to stimulate bone growth, while the mineralized graft retains the mineral content to provide structural support and slower bioactive molecule release. Both grafts are covered with a resorbable collagen dressing and the site is closed. The control group receives no graft and heals naturally. The study lasts six months, allowing detailed comparison of how each approach supports ridge preservation. Participants will have their ridge width, height, and bone density measured at the time of extraction and six months later using CBCT imaging. Additional assessments include patient-reported pain and swelling shortly after surgery, satisfaction with treatment, keratinized tissue width, and bone biopsy analysis at implant placement. Follow-up visits will monitor healing and outcomes to determine which graft type better maintains bone structure and supports future dental restoration.

CONDITIONS

Brief Title

Comparison of Demineralized and Mineralized Dentin Grafts in Ridge Preservation

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 60 years
  • Medically healthy patients classified as ASA I
  • Presence of a single non-restorable tooth indicated for extraction in the posterior maxilla
  • Adequate oral hygiene, with plaque and bleeding indices both below 20%
  • Sufficient bone volume to allow socket preservation without requiring simultaneous augmentation
  • Patients willing to participate in the study and able to provide written informed consent
  • Ability to commit to follow-up visits for up to 6 months
Not Eligible

You will not qualify if you...

  • Smokers or tobacco users of any form
  • Presence of uncontrolled systemic diseases (e.g., uncontrolled diabetes)
  • Conditions affecting bone metabolism (e.g., osteoporosis, long-term corticosteroid therapy)
  • Pregnant or lactating women
  • History of radiotherapy in the head and neck region
  • Active infection or suppuration at the extraction site
  • Immunocompromised patients or those on immunosuppressive therapy
  • Patients taking medications known to impair healing (e.g., bisphosphonates)
  • Allergy or hypersensitivity to any study-related materials

AI-Screening

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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 - Immediate placement following tooth extraction with healing observed for up to 6 months

Participants undergo tooth extraction followed by placement of either a demineralized or mineralized allogeneic dentin graft into the extraction socket, or natural healing without graft placement. The site is closed using standard surgical techniques and covered with a resorbable collagen dressing when grafts are placed.

1 surgical visit and periodic follow-up visits during the healing period

Follow-up

Duration - Up to 6 months post-operative

Participants are monitored postoperatively to assess healing, bone regeneration, and ridge preservation through clinical inspection, radiographic imaging, and if feasible, histological analysis at approximately 6 months after treatment.

Follow-up visits at 24, 48, and 72 hours post-operative and additional visits up to 6 months including implant placement evaluation

Trial Site Locations

Total: 1 location

1

Faculty of Dentistry, Kafrelsheikh University

Kafr ash Shaykh, Egypt

Actively Recruiting

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Research Team

A

Ahmed Abdelaziz, BDS, MSc candidate

E

Enas Elgendy, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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