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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04055935
Other study ID # Doctor's degree research
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2017
Est. completion date June 1, 2019

Study information

Verified date August 2019
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aimed to evaluate the effect of using full thickness mucoperiosteal flap (FTMPF) elevation only versus low level laser therapy (LLLT) on acceleration of orthodontic tooth movement.


Description:

This study was a split mouth design study included 32 side according to sample size calculation. Those sides were divided into 2 groups. Group 1divided into (group 1a: 8 sides with FTMPF, group 1b:8 sides control). Group 2(group 2 a: 8 sides with LLLT, group 2b: 8 sides control). Extraction of the first maxillary premolars followed by canine retraction in the extraction space with maximum anchorage were indicated. FTMPF was elevated from the mesial interdental papilla of maxillary canine to the mesial interdental papilla of second maxillary premolar. LLLT was applied at 3,7,14,28.56 days of retraction. During retraction study model for all patients were taken at 2ed, 6th, 14th,16th weeks and at the end of retraction (I1,I2,I3,I4,I5 or overall interval). 3D laser scanning and digital superimposition was done to measure the rate of canine retraction and anchorage loss.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date June 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 20 Years
Eligibility Inclusion Criteria:

- o Free of any syndromes affecting the head region or any craniofacial injuries.

- No history of previous orthodontic treatment

- All of the permanent dentition present excluding third molars.

- Good oral hygiene before starting treatment.

- Cases indicated for extraction of the maxillary first premolars and canine retraction into the extraction space with maximum anchorage.

- Malocclusion cases that allow initial stage of leveling and alignment without extraction.

Exclusion Criteria:

- o Patients with systemic diseases especially bleeding disorders and osteoporosis.

- History of administration of corticosteroids, exogenous hormones and non-steroidal anti-inflammatory drugs (all drugs interfere with OTM).

- Presence of previous history of oral surgeries in maxillary arch.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
elevation of full thickness mucoperiosteal flap
A free gingival sulcular incision was done from the distal surface of maxillary second premolar to the mesial side of the maxillary canine. A releasing oblique incision was done including the interdental papilla between maxillary canine and lateral incisor extending to the mucogingival junction just beyond the attached mucosa. The flap reflection extended beyond the canine root apex. A FTMPF reflection was done with mucoperiosteal elevator. Free sulcus incision was done to allow elevation of palatal mucosa by tunneling technique on the palatal gingiva of maxillary canine.
Device:
low level laser therapy
LLLT was done using a diode soft laser (Epic X, BioLase, USA). It is a semiconductor diode soft laser. Active medium is In-Ga-As with 940nm wave length. LLLT protocol was using active laser tip (bleaching tip)

Locations

Country Name City State
Egypt Faculty of dentistry ,Al-Azhar Univerisity Cairo Naser City

Sponsors (1)

Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary rate of orthodontic tooth movement acceleration determination by measuring the rate of maxillary canine retraction measure the rate of canine retraction on series of study models the rate of retraction( distance from the first day of retraction to the end of retraction/ time)) it was with total time frame 24 weeks for starting of retraction
Secondary clinical mesial movement of first maxillary molar measured by millimeter on the 3D model amount of mesial movement of first maxillary molar after 24 month t0(start of canine retraction) to 24 months
See also
  Status Clinical Trial Phase
Completed NCT01695928 - Effect of Shock Waves on Tooth Movement and Miniscrew Stability Phase 2/Phase 3