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Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02975765
Date of registration:	24/11/2016
Prospective Registration:	No
Primary sponsor:	Damascus University
Public title:	Evaluation of the Levels of Pain and Discomfort Between Two Methods of Correcting Misaligned Teeth
Scientific title:	Evaluation of the Levels of Pain and Discomfort Between Piezosurgery-assisted Corticotomy Versus Traditional Method of Aligning Crowded Lower Anterior Teeth: a Randomized Controlled Trial
Date of first enrolment:	March 2016
Target sample size:	36
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02975765
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:	Bassel Brad, DDS MSc PhD
Address:
Telephone:
Email:
Affiliation:	Associate Professor of Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, Univ. of Damascus Dental School

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

Name:	Omar Gibreal, DDS
Address:
Telephone:
Email:
Affiliation:	MSc student, Oral and Maxillofacial Surgery Department, University of Damascus Dental School

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Adult healthy patients , Male and female, Age range: 16-26 years.

2. Severe crowding = 7 (Little's irregularity index)

3. Permanent occlusion.

4. Exist all the Mandibular teeth (except third molars).

5. Good oral and periodontal health:

- Probing depth<4 mm

- No radiographic evidence of bone loss .

- Gingival index= 1

- Plaque index = 1

Exclusion Criteria:

1. Medical problems that affect tooth movement (corticosteroid, NSAIDs, …)

2. Patients have anti indication for oral surgery ( medical - social - psycho)

3. Presence of primary teeth in the mandibular arch

4. Missing permanent mandibular teeth (except third molars).

5. Poor oral hygiene or Current periodontal disease:

- Probing depth = 4 mm

- radiographic evidence of bone loss

- Gingival index > 1

- Plaque index > 1

6. Patient had previous orthodontic treatment

Age minimum: 16 Years
Age maximum: 26 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crowded Teeth

Malocclusion

Surgical Incision

Intervention(s)

Procedure: Piezosurgery

Primary Outcome(s)

Levels of Pain and Discomfort at 14 days [Time Frame: at 14 days following the onset of orthodontic treatment]

Levels of Pain and Discomfort at one day [Time Frame: at 24 hours following the engagement of first initial arch wire in the brackets]

Levels of Pain and Discomfort at seven days [Time Frame: at seven days following the onset of orthodontic treatment]

Levels of Pain and Discomfort at 28 days [Time Frame: at 28 days following the onset of orthodontic treatment]

Secondary Outcome(s)

Secondary ID(s)

UDDS-OMFS-02-2016

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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