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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03279042
Date of registration:	31/08/2017
Prospective Registration:	No
Primary sponsor:	Damascus University
Public title:	Effectiveness of Two Corticotomy Techniques in Retracting the Upper Anterior Teeth by Using Miniscrews
Scientific title:	An Evaluation of the Efficacy of Conventional Corticotomy Versus Flapless Corticotomy in the En-Masse Retraction of Upper Anterior Teeth : A Randomized Controlled Trial
Date of first enrolment:	September 12, 2016
Target sample size:	20
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03279042
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
Phase:	N/A

Countries of recruitment
Syrian Arab Republic

Contacts

Name:	Omar Hashmeh, DDS MSc PhD
Address:
Telephone:
Email:
Affiliation:	Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Syria

Name:	Mohammad Y Hajeer, DDS MSc Phd
Address:
Telephone:
Email:
Affiliation:	Associate Professor of Orthodontics, University of Damascus Dental School, Syria

Name:	Hanin Nizar Khlef, DDS
Address:
Telephone:
Email:
Affiliation:	MSc student, Department of Orthodontics, University of Damascus Dental School, Syria

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult patients with permanent occlusion at age 18-30 years.

- Comprehensive medical and dental history ruling out any systemic disease

- Not under any systemic medication.

- No previous orthodontic treatment

- Patients with satisfactory periodontal health and Good oral hygiene

- Need to orthodontic treatment with fixed appliances

- No congenitally missing teeth except third molars in the maxillary arch

- Mild or no anterior crowding in maxillary arch.

- Maximum anchorage, with 75% to 100% of space closure of retraction of anterior segment
in maxillary arch.

- Therapeutic extraction of maxillary first premolars required.

- Patients with class ? division 1 (ANB angle =7 degrees) with severe overjet (5-10 mm)

- Maximum retraction of the anterior teeth was desired.

Exclusion Criteria:

- Patients with previous orthodontic treatment.

- Patients with severe skeletal dysplasia in all three dimensions.

- Patients suffer from systemic diseases or syndromes

- Patients on medication for systemic disorders, pregnancy or steroid therapy.

- Patients showing any signs of active periodontal disease

- Patients with severe crowding (= 3.5 mm) in maxillary arch

- Patients with missing or extracted teeth in maxillary arch except third molar.

Age minimum: 18 Years
Age maximum: 30 Years
Gender: All

Health Condition(s) or Problem(s) studied

Class II Div 1 Malocclusion

Protrusion, Incisor

Intervention(s)

Procedure: Flapless corticotomy surgical intervention will be conducted

Procedure: Traditional corticotomy

Primary Outcome(s)

Change in the SNA angle [Time Frame: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.]

Duration of en-masse retraction of anterior teeth [Time Frame: The months required to compete the retraction procedure will be recorded. Completion of this procedure is expected to be occur within six months in the experimental group and eight months in the control group.]

Change in Molars' positions [Time Frame: T0: 1 day before the beginning of retraction. T1: after 1 month (m) of retraction. T2: after 2 m of retraction. T3: after 3 m. T4: after 4 m. T5: at the end of retraction (expected to be within 6 m in the exp. group and 8 m in the control group)]

Change in the SNB angle [Time Frame: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.]

Change in the MM angle [Time Frame: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.]

Change in the SN.GoMe angle [Time Frame: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.]

Change in Incisors' positions [Time Frame: T0: 1 day before the beginning of retraction. T1: after 1 month (m) of retraction. T2: after 2 m of retraction. T3: after 3 m. T4: after 4 m. T5: at the end of retraction (expected to be within 6 m in the exp. group and 8 m in the control group)]

Rate of retraction [Time Frame: The calculation of the rate of retraction will be done once the retraction procedures has finished. Completion of this procedure is expected to occur within 6 months in the experimental group and 8 months in the control group.]

Change in the ANB angle [Time Frame: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.]

Secondary Outcome(s)

Change in the Bleeding index [Time Frame: This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.]

Change in the Gingival index [Time Frame: This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.]

Change in the Plaque index [Time Frame: This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.]

Change in the levels of pain and discomfort [Time Frame: Levels of pain will be assessed at : 24 hours following the surgical intervention (T1), one week (T2) , two weeks (T3) and four weeks (T4) following the surgical intervention]

Change in Tooth Vitality [Time Frame: This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.]

Gingival Recession [Time Frame: Two measurements are required for this calculation: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.]

Secondary ID(s)

UDDS-Ortho-04-2017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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