NCT05988086

Brief Summary

The aim of this prospective study is to evaluate both clinically and radiologically the efficacy of using autologous platelets rich fibrin versus collagen membrane for nasal layer closure in secondary alveolar cleft repair.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

5 months

First QC Date

July 20, 2023

Last Update Submit

November 20, 2023

Conditions

Alveolar Cleft

Keywords

alveolar cleftcollagen membraneplatelet rich fibrin

Outcome Measures

Primary Outcomes (3)

  • 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

  • density of bone

    density of bone to measure (D1,D2,D3,D4) Frome 150HU to 1250HU

    1 month

Secondary Outcomes (1)

  • bone mineral density.

    9 months

Study Arms (2)

Group 1: platelet rich fibrin

ACTIVE COMPARATOR

Group 1: This will include 12 children in whom nasal layer of alveolar cleft will be repaired using autologous platelet rich fibrin with autogenous chin bone.

Procedure: platelet rich fibrin

Group 2:collagen membrane

ACTIVE COMPARATOR

Group 2: This will include 12 children in whom nasal layer of alveolar cleft will be repaired using collagen membrane with autogenous chin bone.

Procedure: collagen membrane

Interventions

platelet rich fibrinPROCEDURE

12 children in whom nasal layer of alveolar cleft will be repaired using autologous platelet rich fibrin with autogenous chin bone.

Group 1: platelet rich fibrin
collagen membranePROCEDURE

12 children in whom nasal layer of alveolar cleft will be repaired using collagen membrane with autogenous chin bone.

Group 2:collagen membrane

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • patients with unilateral alveolar cleft
  • the patient's permenant canines either not or partially erupted
  • medically free patients

You may not qualify if:

  • patients with bilateral alveolar cleft
  • medically compromised patients
  • Any associated craniofacial syndromes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Egypt

Tanta, 3111, Egypt

Location

Study Officials

  • Marwa T Ibrahim, lecturer

    Tanta University

    PRINCIPAL INVESTIGATOR

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
lecturer

Study Record Dates

First Submitted

July 20, 2023

First Posted

August 14, 2023

Study Start

October 10, 2022

Primary Completion

March 10, 2023

Study Completion

September 30, 2023

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)