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Completed

NCT Number: NCT05988086

Double Closure of Nasal Layer in Alveolar Cleft Grafting

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.

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Key information

Conditions

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Egypt

Tanta, 3111, Egypt

About this study

Patients and methods: Twenty-four patients with alveolar clefts will be included in this study. The patients will be evaluated with age ranging between (7 - 12) years. The patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.

The selected children should possess the following criteria: Their permanent canines either not or partially erupted, has no systemic disorder which can affect the grafting outcome and healing process such as juvenile diabetes mellitus, kidney, liver, or blood diseases and has no associated craniofacial syndromes. The patients will be classified into two groups according to incorporation of autologous platelet rich fibrin or collagen membrane for nasal layer closure with the grafting material, as follow: 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. Group 2: This will include 12 children in whom nasal layer of alveolar cleft will be repaired using collagen membrane with autogenous chin bone.

Preoperative evaluation of alveolar cleft site:

all patients will be examined clinically and radiologically. Clinical examination: This will consider the stability of maxillary segments, presence of old scar, asymmetry of the alar base, presence of oronasal fistula, and the presence of erupting teeth in the cleft.

Radiological examination: Panoramic radiographs will be done for each patient and examined as regard: the morphology of the cleft area, the size of the cleft side, the presence or absence of permanent lateral incisor and canine, the development of root length, and stage of eruption of permanent canine and lateral incisor. In addition, Axial computed tomography (CT) scans will be done for each patient to assess and measure local bone mineral density of grafted alveolar bone cleft.

Postoperative evaluation of the grafted site:

The grafted site will be evaluated clinically for healing condition at the follow up periods (1st week, then 1st , 3rd ,6th ,and 9th month postoperatively) ; regarding the presence of inflammation or infection , the soft tissue scar overlying the bone graft , tenderness of bone graft site , recurrence of oronasal fistula , alveolar ridge contour in cleft region and eruption of cleft related teeth . Radiological evaluation will be done for each patient using Axial computed tomography (CT) scans at the follow up period (3rd and 9th month postoperatively) to assess and measure local bone mineral density.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Platelet Rich Fibrin

Procedure

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

Collagen membrane

Procedure

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

Primary outcomes

  1. visual analogue scale

    Time frame: 1 month

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

  2. inflammation score scale

    Time frame: 1 month

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

  3. density of bone

    Time frame: 1 month

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

Secondary outcomes

  1. bone mineral density.

    Time frame: 9 months

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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Evaluation of Using Platelet Rich Fibrin Versus Collagen Membrane for Enhancing Healing of Secondary Grafted Alveolar Cleft

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 14, 2023
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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