Periodontal Changes Following Mid Maxillary Distraction

NCT03686761 | Completed

• 1 other identifier: 00010556
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Cleft Lip and Palate; Periodontal Pocket; Attachment Loss, Periodontal

Keywords

Inflammation; Healing; Distraction; Periodontium

Outcome Measures

Primary Outcomes (1)

• Measurement of periodontal inflammatory mediators

  periodontal inflammatory mediators IL-1β

  7 days

Secondary Outcomes (4)

• Measurement of periodontal inflammatory mediators TNF- α

  7 days

• Assessment of periodontal probing depth

  3 and 6 month

• Assessment of clinical attachment loss

  3 and 6 month

• Assessment of periodontal clinical parameters

  3 and 6 month

Other Outcomes (1)

• Evaluating the gingival histological changes

  2 and 4 weeks

Study Arms (2)

Study

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

A Involvement with the osteotomy site of the surgery PROCEDURE

A Involvement with the osteotomy site of the surgery

Control; Study

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Severe maxillary hypoplasia and negative anterior overjet

You may not qualify if:

• Systemic disease

Sponsors & Collaborators

• University of Alexandria: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry

Alexandria, 21221, Egypt

Location

MeSH Terms

Conditions

Cleft Lip; Periodontal Pocket; Periodontal Attachment Loss; Inflammation

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Periodontitis; Periodontal Diseases; Periodontal Atrophy; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marwa Madi

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: The clinical assessment was not masked , however, the histological and biomarker examination were send to blind investigator not directly involved in the study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: September 27, 2018
• Study Start: February 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 2, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)