Skip to content

Periodontal Changes Following Mid Maxillary Distraction

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03686761
Enrollment
20
Registered
2018-09-27
Start date
2015-02-28
Completion date
2016-10-31
Last updated
2018-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Inflammation, Healing, Distraction, Periodontium

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).

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.

Interventions

PROCEDUREA Involvement with the osteotomy site of the surgery

A Involvement with the osteotomy site of the surgery

Sponsors

Alexandria University
CollaboratorOTHER
University of Alexandria
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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

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.

Eligibility

Sex/Gender
ALL
Age
16 Years to 25 Years
Healthy volunteers
Yes

Inclusion criteria

* Severe maxillary hypoplasia and negative anterior overjet

Exclusion criteria

* Systemic disease

Design outcomes

Primary

MeasureTime frameDescription
Measurement of periodontal inflammatory mediators7 daysperiodontal inflammatory mediators IL-1β

Secondary

MeasureTime frameDescription
Measurement of periodontal inflammatory mediators TNF- α7 daysperiodontal inflammatory mediators TNF- α
Assessment of periodontal probing depth3 and 6 monthprobing depth measurement
Assessment of clinical attachment loss3 and 6 monthclinical attachment loss measurement
Assessment of periodontal clinical parameters3 and 6 monthGingival index evaluation GI

Other

MeasureTime frameDescription
Evaluating the gingival histological changes2 and 4 weekshistological examination of the soft tissue

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026