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Completed

NCT Number: NCT03686761

Periodontal Changes Following Mid Maxillary Distraction

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

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Key information

Conditions

Cleft Lip and Palate Attachment Loss, Periodontal Cleft Lip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Inflammation Lip Diseases Mouth Abnormalities Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Atrophy Periodontal Attachment Loss Periodontal Diseases Periodontal Pocket Periodontitis Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

16 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Alexandria, 21221, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Severe maxillary hypoplasia and negative anterior overjet

Exclusion criteria

  • Systemic disease

Treatment and study plan

A Involvement with the osteotomy site of the surgery

Procedure

A Involvement with the osteotomy site of the surgery

Primary outcomes

  1. Measurement of periodontal inflammatory mediators

    Time frame: 7 days

    periodontal inflammatory mediators IL-1β

Secondary outcomes

  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 outcomes

  1. Evaluating the gingival histological changes

    Time frame: 2 and 4 weeks

    histological examination of the soft tissue

Sponsors and collaborators

Lead sponsor

University of Alexandria

Other

Collaborators

  • Alexandria University

Registry information

Official study title

Periodontal Changes and Gingival Soft Tissue Healing Following Mid Maxillary Distraction in Cleft Lip and Palate Patients

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 27, 2018
Registry last updated
Oct 2, 2018

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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