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

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ClinicalTrials.gov Identifier: NCT03535285
Recruitment Status : Completed
First Posted : May 24, 2018
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Monaser Mobarak, Cairo University

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

Condition or disease Intervention/treatment Phase
Orthodontic Appliance Complication Procedure: Periodontal ligament distraction Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Split-mouth
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Periodontal Ligament Distraction Using a Modified Surgical Technique for Retraction of Maxillary Canines in Adult Patients (Split-mouth Randomized Clinical Trial)
Actual Study Start Date : June 15, 2017
Actual Primary Completion Date : August 15, 2017
Actual Study Completion Date : December 15, 2017

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 Name: Acceleration of canine retraction

Active Comparator: Conventional surgery
Periodontal ligament distraction
Procedure: Periodontal ligament distraction
decrease the bony resistant during canine retration
Other Name: Acceleration of canine retraction




Primary Outcome Measures :
  1. Tipping of the canines [ Time Frame: 3-4 weeks ]
    1. Periapical radiograph using Parallel technique (X-ray sensor , X-ray sensor holder & Potable dental x-ray unit
    2. Panoramic radiograph .

  2. Rate of canines retraction [ Time Frame: 3-4 weeks ]
    Digital models using 3shape scanner and Ortho-Analyzer software

  3. Rotation of the canines [ Time Frame: 3-4 weeks ]
    Digital models using 3shape scanner and Ortho-Analyzer software


Secondary Outcome Measures :
  1. Amount of anchorage loss [ Time Frame: 3-4 weeks ]
    Digital models using 3shape scanner and Ortho-Analyzer software

  2. Tipping of the molars [ Time Frame: 3-4 weeks ]
    1. Periapical radiograph using Parallel technique (X-ray sensor , X-ray sensor holder & Potable dental x-ray unit
    2. Panoramic radiograph.

  3. The apical root resorption scores [ Time Frame: 3-4 weeks ]
    Periapical radiograph using Parallel technique (x-ray sensor, X-ray sensor holder & Potable dental x-ray unit

  4. Pulp Vitality [ Time Frame: 3-4 weeks ]
    Cold application (Ethyl Chloride)

  5. Gingival index [ Time Frame: 3-4 weeks ]
    Periodontal probe

  6. Periodontal index [ Time Frame: 3-4 weeks ]
    Periodontal probe

  7. Pain [ Time Frame: 3-4 weeks ]
    Numeric rating scale (NRS) for pain



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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03535285


Locations
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Egypt
Cairo University - Orthodontic department
Cairo, Egypt, 11111
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Monaser M Elashik, Master Cairo University

Additional Information:
Publications of Results:
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Responsible Party: Monaser Mobarak, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03535285     History of Changes
Other Study ID Numbers: 11111
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Monaser Mobarak, Cairo University:
periodontal ligament
dentoalveolar
distraction
orthodontic