Evaluation of Periodontal Ligament Distraction Using a Modified Surgical Technique for Retraction of Maxillary Canines ([PLD])

Evaluation of Periodontal Ligament Distraction Using a Modified Surgical Technique for Retraction of Maxillary Canines in Adult Patients (Split-mouth Randomized Clinical Trial)

Surgical modification technique try to get bodily movement during upper canine retraction.

Study Overview

• Status: Completed
• Conditions: Orthodontic Appliance Complication
• Intervention / Treatment: Procedure: Periodontal ligament distraction

Detailed Description

I- Original surgical technique (Liou and Huang technique, 1998) :

On the conventional surgical side, (the control side), the intersepital bone was undermined by two vertical cuts on the mesio-buccal and mesio-palatal line angles of the first premolar socket. They were connected at the base of the socket by an oblique cut. The surgical round bur was held parallel to the long axis of the canine and moved buccolingually, while shaving the interseptal bone buccolingual (back-and-forth) shaving movements were reduced the thickness of the interseptal bone by approximately 1 mm

II- Modified surgical technique:

In the surgical modification side, (the experimental side), intra-alveolar mesio-buccal and mesio-palatal cuts and interseptal bone shaving were done by surgical round bur and copious irrigation, without the oblique cut since it was done blindly in the original surgical technique. A buccal semilunar flap was opened on the apical area of canine-premolar region. The surgical pin helped also in location of the point of initial drilling of the apical horizontal cut from buccal approach, when the surgical pin's socket arm rested on the depth of the socket, the vestibular arm marked the point of access. It also estimated mesiodeistal extension of the apical horizontal cut. The apical horizontal cut was started from the socket apex to half way of the interseptal bone mesiodistally as an extension and for the depth, Mallet and Chisel were used from the cortical bone to reach the mesio-palatal cut. The flap was sutured. This surgical modification step provided more predictability and safer surgery than the blind oblique cut in the original surgical technique.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11111
    • Cairo University - Orthodontic department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Orthodontic patients needed extraction of upper first premolars, with age range from 18 - 25 years old.
2. All patients were medically free. (See Appendix II)
3. No previous orthodontic treatment.
4. Adequate oral hygiene and periodontally healthy teeth.
5. The canines were almost leveled and aligned.
6. Maximum anchorage requirements.
7. Healthy canines; no deep carious lesions, no endodontic lesions, no root canal treatment, nor internal or external root resorption.
8. All patients were informed of the procedure and signed the consents.

Exclusion Criteria:

Exclusion Criteria

Subjects were excluded from the study when:

1. They failed to keep several consecutive appointments.
2. Oral hygiene was subjectively judged as deteriorating during the preliminary stages of patient preparation.
3. Compliance with the instructions provided was inadequate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Surgical modification side; Periodontal ligament distraction without the oblique cuts but with apical horizontal cut	Procedure: Periodontal ligament distraction; decrease the bony resistant during canine retration; Other Names: Acceleration of canine retraction
ACTIVE_COMPARATOR: Conventional surgery; Periodontal ligament distraction	Procedure: Periodontal ligament distraction; decrease the bony resistant during canine retration; Other Names: Acceleration of canine retraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tipping of the canines	Periapical radiograph using Parallel technique (X-ray sensor , X-ray sensor holder & Potable dental x-ray unit; Panoramic radiograph .	3-4 weeks
Rate of canines retraction	Digital models using 3shape scanner and Ortho-Analyzer software	3-4 weeks
Rotation of the canines	Digital models using 3shape scanner and Ortho-Analyzer software	3-4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of anchorage loss	Digital models using 3shape scanner and Ortho-Analyzer software	3-4 weeks
Tipping of the molars	Periapical radiograph using Parallel technique (X-ray sensor , X-ray sensor holder & Potable dental x-ray unit; Panoramic radiograph.	3-4 weeks
The apical root resorption scores	Periapical radiograph using Parallel technique (x-ray sensor, X-ray sensor holder & Potable dental x-ray unit	3-4 weeks
Pulp Vitality	Cold application (Ethyl Chloride)	3-4 weeks
Gingival index	Periodontal probe	3-4 weeks
Periodontal index	Periodontal probe	3-4 weeks
Pain	Numeric rating scale (NRS) for pain	3-4 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Monaser M Elashik, Master, Cairo University

Publications and helpful links

General Publications

• Liou EJ, Huang CS. Rapid canine retraction through distraction of the periodontal ligament. Am J Orthod Dentofacial Orthop. 1998 Oct;114(4):372-82. doi: 10.1016/s0889-5406(98)70181-7.

Helpful Links

• periodontal ligament distraction

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2017
• Primary Completion (ACTUAL): August 15, 2017
• Study Completion (ACTUAL): December 15, 2017

Study Registration Dates

• First Submitted: May 10, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (ACTUAL): May 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 25, 2018
• Last Update Submitted That Met QC Criteria: May 23, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: distraction; orthodontic; periodontal ligament; dentoalveolar
• Other Study ID Numbers: 11111 (DAIDS ES Registry Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No