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Periodontal Changes Following Mid Maxillary Distraction

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ClinicalTrials.gov Identifier: NCT03686761
Recruitment Status : Completed
First Posted : September 27, 2018
Last Update Posted : October 2, 2018
Sponsor:
Collaborator:
Alexandria University
Information provided by (Responsible Party):
Marwa Ibrahim Madi, University of Alexandria

Brief Summary:
To evaluate the health status of the periodontium and dentition at the distraction osteogenesis site in CLP subjects using mid maxillary distraction (MMD).

Condition or disease Intervention/treatment Phase
Cleft Lip and Palate Periodontal Pocket Attachment Loss, Periodontal Procedure: A Involvement with the osteotomy site of the surgery Not Applicable

Detailed Description:
Segmental forward maxillary distraction osteogenesis(DO)was performed. Distractor connecting buccal molar segments to the anterior maxilla was kept for 7 days. Then distraction was performed till overcorrection and consolidated for 3-months. Periodontal clinical parameters were recorded at baseline, 3 and 6-months postoperatively. Gingival crevicular fluid was collected . Soft tissue healing was evaluated clinically and histologically after distraction.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Surgical distraction was performed in 20 cleft lip and palate (CLP) subjects with class III malocclusion, gingival GCF were collected from teeth neighboring the osteotomy site and from premolars of the opposite arch as control.
Masking: None (Open Label)
Masking Description: The clinical assessment was not masked , however, the histological and biomarker examination were send to blind investigator not directly involved in the study
Primary Purpose: Treatment
Official Title: Periodontal Changes and Gingival Soft Tissue Healing Following Mid Maxillary Distraction in Cleft Lip and Palate Patients
Actual Study Start Date : February 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study
A Involvement with the osteotomy site of the surgery, osteotomy was performed then GCF were collected from teeth neighboring the
Procedure: A Involvement with the osteotomy site of the surgery
A Involvement with the osteotomy site of the surgery

Active Comparator: Control
Involvement with the osteotomy site of the surgery, surgical osteotomy was performed then GCF were collected from teeth away from the osteotomy site
Procedure: A Involvement with the osteotomy site of the surgery
A Involvement with the osteotomy site of the surgery




Primary Outcome Measures :
  1. Measurement of periodontal inflammatory mediators [ Time Frame: 7 days ]
    periodontal inflammatory mediators IL-1β


Secondary Outcome Measures :
  1. Measurement of periodontal inflammatory mediators TNF- α [ Time Frame: 7 days ]
    periodontal inflammatory mediators TNF- α

  2. Assessment of periodontal probing depth [ Time Frame: 3 and 6 month ]
    probing depth measurement

  3. Assessment of clinical attachment loss [ Time Frame: 3 and 6 month ]
    clinical attachment loss measurement

  4. Assessment of periodontal clinical parameters [ Time Frame: 3 and 6 month ]
    Gingival index evaluation GI


Other Outcome Measures:
  1. Evaluating the gingival histological changes [ Time Frame: 2 and 4 weeks ]
    histological examination of the soft tissue



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Ages Eligible for Study:   16 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Severe maxillary hypoplasia and negative anterior overjet

Exclusion Criteria:

  • Systemic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686761


Locations
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Egypt
Faculty of Dentistry
Alexandria, Egypt, 21221
Sponsors and Collaborators
University of Alexandria
Alexandria University
Investigators
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Principal Investigator: Marwa Madi Alexandria University
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Responsible Party: Marwa Ibrahim Madi, Principle investigator, University of Alexandria
ClinicalTrials.gov Identifier: NCT03686761    
Other Study ID Numbers: 00010556
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marwa Ibrahim Madi, University of Alexandria:
Inflammation
Healing
Distraction
Periodontium
Additional relevant MeSH terms:
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Cleft Lip
Periodontal Pocket
Periodontal Attachment Loss
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities
Periodontitis
Periodontal Diseases
Periodontal Atrophy