NCT06657651

Brief Summary

forty patients will be selected from the outpatient's clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of non-restorable tooth in posterior mandibular area. Patients' Grouping: The patients will be randomly divided into two equal uniform groups each consists of 20 patients: Group A: 20 patients with non-restorable mandibular molar tooth will be treated with an immediately placed dental implant in conjunction with a dentin-derived membrane from the extracted tooth. Group B: 20 patients with non-restorable mandibular molar tooth will be treated with an immediately placed dental implant in conjunction with extended platelet rich fibrin 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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

June 30, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

October 28, 2024

Status Verified

October 1, 2024

Enrollment Period

8 months

First QC Date

October 23, 2024

Last Update Submit

October 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Implant stability

    Osstell will be used to record implant stability at the placement time, 3, 6 and 12 months after surgery.

    1 year

Study Arms (2)

immediate implant with dentin-derived membrane

EXPERIMENTAL
Procedure: immediate implant placement with dentin-derived membrane

immediate implant with extended platelet rich fibrin membrane

EXPERIMENTAL
Procedure: immediate implant with extended platelet rich fibrin membrane

Interventions

immediate implant placement with dentin-derived membrane and allograft in mandibular molar area

immediate implant with dentin-derived membrane

immediate implant with extended platelet rich fibrin membrane and allograft in mandibular molar area

immediate implant with extended platelet rich fibrin membrane

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age above 18 years
  • Non-restorable mandibular molar tooth that needs dental extraction \& guided bone regeneration for immediate implant placement.
  • Acceptable inter-arch space for the future prosthesis.
  • Patient medically free from systemic diseases that absolutely contraindicate implant surgery.
  • Cooperative patient with high motivation and acceptable oral hygiene.
  • Free from history of bruxism / parafunctional habits.

You may not qualify if:

  • Local and / or systemic conditions that interfere with the procedure.
  • Smokers.
  • Pregnancy.
  • Uncooperative patients.
  • Patient had undergone in the past 12 months radiation therapy to the head and neck area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heba Elsheikh

Al Mansurah, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2024

First Posted

October 24, 2024

Study Start

June 30, 2024

Primary Completion

March 1, 2025

Study Completion

June 1, 2025

Last Updated

October 28, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations