NCT06615362

Brief Summary

Autogenous Dentin Derived Barrier Membrane versus Collagen Membrane

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed
Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

September 7, 2024

Last Update Submit

September 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • All patients were evaluated radiographically immediately postoperative,and after 12 months

    Radiographic Evaluation Cone Beam Computed Tomography scan was taken to measure Marginal Bone loss and Relative bone density

    1 year

Study Arms (2)

Autogenous Dentin Derived Barrier Membrane

EXPERIMENTAL

Autogenous Dentin Derived Barrier Membrane + Xenogeneic bone graft material+ immediate implant

Procedure: preparation of dentin membrane from hopeless tooth for Guided Bone Regeneration in Immediate Implant

Collagen Membrane

EXPERIMENTAL

Collagen Membrane + Xenogeneic bone graft material + immediate implant

Procedure: Collagen Membrane for Guided Bone Regeneration in Immediate Implant

Interventions

tooth extraction , preparation of dentin membrane ,immediate implantation ,Xenogeneic bone graft material, application of dentin derived barrier membrane

Autogenous Dentin Derived Barrier Membrane

like group one but with application of collagen membrane

Collagen Membrane

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient's age ranges from 18-50 years.
  • Adequate inter-arch relation and inter-occlusal space that could accommodate the implant abutment and the future restoration
  • Non-restorable tooth that needs dental extraction \& guided bone regeneration for immediate implant.
  • Presence of alveolar bone defect with vertical loss of buccal bone more than a third implant thread.
  • Co-operative patients willing to complete the follow-up periods.

You may not qualify if:

  • Any pathological condition at site of surgery.
  • Patients with systemic diseases that contra-indicate the surgical procedure.
  • Heavy smoking.
  • Parafunctional habits such as bruxism and clenching.
  • Pregnant patients. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mansoura University, faculty of dentistry ,Department of Oral and Maxillofacial

Al Mansurah, Eygpt, 002, Egypt

Location

Elhussein Farag

Al Mansurah, Eygpt, Egypt

Location

Related Publications (1)

  • Mohamad EHFA, Awad S, Abbas MH, Elsheikh HA. Autogenous dentin-derived membrane as a biologic alternative to collagen membrane for guided bone regeneration in immediate implant placement in the posterior mandible: a randomized clinical trial. Odontology. 2025 Dec 10. doi: 10.1007/s10266-025-01271-6. Online ahead of print.

Study Officials

  • Heba Elsheikh Assistant professor, Assistant professor

    Mansoura University, faculty of dentistry ,Department of Oral and Maxillofacial

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two arms: one arm Autogenous Dentin Derived Barrier Membrane ,second arm Collagen Membrane .
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2024

First Posted

September 26, 2024

Study Start

April 10, 2022

Primary Completion

April 10, 2024

Study Completion

October 10, 2024

Last Updated

September 26, 2024

Record last verified: 2024-09

Locations