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Evaluation of the Levels of Pain and Discomfort Associated With Two Techniques of Corticotomy

NCT05040945 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-09-10

No results posted yet for this study

Summary

This study aims to estimate the levels of pain and discomfort associated with the en-masse retraction of the six upper anterior teeth and assisted by either conventional or flapless corticotomy.

Thirty-four adult patients exhibiting class П division 1 malocclusion will be randomly allocated to either the conventional corticotomy group or the flapless corticotomy group, and they will be treated by extraction of maxillary first premolars with applying mini-screws between maxillary second premolar and first molar as temporary skeletal anchorage devices (TSADs). The levels of pain and discomfort will be rated after 24 hours of corticotomy (T1), four days (T2), seven days (T3), 14 days (T4) and after 28 days of corticotomy, by asking the patients to fill in a questionnaire for assessing levels of pain and discomfort.

Conditions

  • Class II Division 1 Malocclusion

Interventions

PROCEDURE

Traditional corticotomy

Adult patients will be treated by extraction of maxillary first premolars with applying mini-screws between maxillary second premolar and first molar as temporary skeletal anchorage devices (TSADs). Then en-masse retraction associated with traditional corticotomy will be applied.

PROCEDURE

Flapless corticotomy

Adult patients will be treated by extraction of maxillary first premolars with applying mini-screws between maxillary second premolar and first molar as temporary skeletal anchorage devices (TSADs). Then en-masse retraction associated with flapless corticotomy will be applied.

Sponsors & Collaborators

  • Damascus University

    lead OTHER

Principal Investigators

  • Hanin Nizar Khlef, DDS,MSc · Specialist and Clinical Lecturer, Department of Orthodontics, University of Damascus

  • Mohammad Y Hajeer, DDS,MSc,PhD · Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria

  • Omar Heshmeh, DDS,MSc,PhD · Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus, Syria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-15
Primary Completion
2018-07-31
Completion
2019-05-15

Countries

  • Syria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05040945 on ClinicalTrials.gov