NCT06702956

Brief Summary

The patient's bone morphology during orthodontic treatment is an important consideration. Therefore, during orthodontic tooth movement (OTM), an imbalance between bone resorption and deposition will cause the tooth to move out of the alveolar envelope . Unfavorable consequences like gingival recession and the dehiscence of an alveolar bone plate may arise from the movement of the teeth beyond the boundary of the bone they are housing. This happened because the dense cortical bone didn't enlarge to maintain protection for the moving root. On the other hand, orthodontic force creates a complex loading pattern and biological response on the periodontal ligament (PDL). there was an increase in osteoclastic activity in a compression region within the PDL. In contrast, in the other tension region, there was an increase in osteoblastic activity and mineralization of the bone matrix.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 25, 2024

Completed
Last Updated

November 25, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

November 3, 2024

Last Update Submit

November 22, 2024

Conditions

Keywords

bony changeslasercanine retractionCBCT

Outcome Measures

Primary Outcomes (1)

  • assessment of labial bone thickness

    assessment of labial bone using CBCT

    6 months

Secondary Outcomes (1)

  • assessment of root length

    6 months

Study Arms (2)

control conventional method

ACTIVE COMPARATOR

conventional method of canine retraction using brackets

Procedure: Conventional tooth movement

study laser corticotomy

ACTIVE COMPARATOR

an accelerated orthodontic movement using Waterlase MDTM Turbo all-tissue laser for corticotomy

Procedure: laser corticotomy

Interventions

stimulation of tooth movement during orthodontics treatment using Waterlase MDTM Turbo all-tissue laser therapy

study laser corticotomy

tooth movement us done using wires and brackets

control conventional method

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients who need extraction of maxillary first premolar in orthodontic treatment and patients who need canine retraction

You may not qualify if:

  • medically compromised patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry , Al Azhar Univeristy For Girls

Cairo, Heliopolis - Cairo, 123456, Egypt

Location

Study Officials

  • Zainab H Abdel Rahman, Phd

    lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized double blinded clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2024

First Posted

November 25, 2024

Study Start

April 1, 2024

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

November 25, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations