NCT06855875

Brief Summary

The aim of this study is evaluation of autogenous tooth-derived graft combined with bovine bone for surgical repair of unilateral alveolar cleft .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2025

Completed
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

February 21, 2025

Last Update Submit

June 29, 2025

Conditions

Alveolar Cleft

Keywords

teeth derived graftbovine bonealveolar cleft grafting

Outcome Measures

Primary Outcomes (2)

  • visual analogue scale

    0 representing no pain and 10 representing the highest level of pain

    1 month

  • inflammation score scale

    0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation

    1 month

Secondary Outcomes (1)

  • bone mineral density

    6 months

Study Arms (2)

autogenous tooth graft combined with bovine bone

EXPERIMENTAL

This include 8 patients with unilateral alveolar cleft which will be repaired using autogenous tooth graft combined with bovine bone .

Procedure: autogenous tooth graft combined with bovine bone

bovine bone

EXPERIMENTAL

This include 8 patients in whom alveolar cleft will be repaired using bovine bone .

Procedure: bovine bone

Interventions

autogenous tooth graft combined with bovine bonePROCEDURE

unilateral alveolar cleft which will be repaired using autogenous tooth graft combined with bovine bone .

autogenous tooth graft combined with bovine bone
bovine bonePROCEDURE

unilateral alveolar cleft which will be repaired using bovine bone .

bovine bone

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients with unilateral alveolar clefts requiring repair.
  • patients free from any systemic disease that may affect normal healing of bone.
  • patients in an age 7y up to 14 y.
  • patients have teeth to be sacrificed, as primary teeth, carious teeth, malposed teeth, supernumerary tooth\& non functional tooth in the study group.

You may not qualify if:

  • Bilateral alveolar clefts.
  • Immunocompromized patients.
  • Syndromic patients.
  • Patients have good full set of teeth, cannot be sacrified in study group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dentistry, Tanta university

Tanta, 31111, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass Prof

Study Record Dates

First Submitted

February 21, 2025

First Posted

March 4, 2025

Study Start

August 10, 2024

Primary Completion

November 10, 2024

Study Completion

May 28, 2025

Last Updated

July 1, 2025

Record last verified: 2025-06

Locations

EG(1)