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

NCT05040945 | Completed DMC

• 1 other identifier: UDDS-Ortho-08-2021
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pain and discomfort; En-masse; Class II division 1; Extraction; Tooth movement acceleration; Traditional corticotomy; Fapless corticotomy; Mini-screws

Outcome Measures

Primary Outcomes (2)

• Change in the levels of pain perception

  Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question.The scale has a minimum scale of 0 (no pain) and a maximum scale of 100 (maximum pain).

  Levels of pain perception will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention

• Change in the levels of discomfort perception

  Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question.The scale has a minimum scale of 0 (no discomfort) and a maximum scale of 100 (maximum discomfort)

  Levels of discomfort perception will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention

Secondary Outcomes (7)

• Change in the levels of swelling perception

  This outcome will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention

• Change in the levels of mastication difficulty perception

  This outcome will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention

• Change in the levels of swallowing difficulty perception

  This outcome will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention

• Change in the levels of Jaw movement restriction perception

  This outcome will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention

• The levels of satisfaction

  This outcome will be assessed after four weeks following the surgical intervention

Study Arms (2)

Traditional corticotomy

ACTIVE COMPARATOR

Adult patients will be treated by en-masse retraction associated with traditional corticotomy

Procedure: Traditional corticotomy

Flapless corticotomy

EXPERIMENTAL

Adult patients will be treated by en-masse retraction associated with flapless corticotomy

Procedure: Flapless corticotomy

Interventions

Traditional corticotomy PROCEDURE

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.

Traditional corticotomy

Flapless corticotomy PROCEDURE

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.

Flapless corticotomy

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age range between 18 and 30 years.
• Class II division 1 malocclusion requiring extraction of upper first premolars.
• Mild to moderate skeletal class II malocclusion.
• Normal or excessive anterior facial height.
• No or mild crowding (tooth-size arch-length discrepancy ≤3 mm).
• Overjet \>5 mm and \<10 mm.
• Completion permanent dentition (regardless of third molars).
• No previous orthodontic treatment.
• No drug use or systematic disease that would affect the bone and tooth movement rate.
• Healthy periodontium and good oral hygiene.

You may not qualify if:

• Patients with previous orthodontic treatment.
• Patients with severe skeletal dysplasia in all three dimensions.
• Patients suffer from systemic diseases or syndromes
• Patients on medication for systemic disorders, pregnancy or steroid therapy.
• Patients showing any signs of active periodontal disease
• Patients with severe crowding (≥ 3.5 mm) in maxillary arch
• Patients with missing or extracted teeth in maxillary arch except third molar.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, University of Damascus Dental School

Damascus, Syria

Location

Related Publications (5)

• Al-Sibaie S, Hajeer MY. Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial. Eur J Orthod. 2014 Jun;36(3):275-83. doi: 10.1093/ejo/cjt046. Epub 2013 Jun 20.

  PMID: 23787192 BACKGROUND

• Khlef HN, Hajeer MY, Ajaj MA, Heshmeh O. En-masse Retraction of Upper Anterior Teeth in Adult Patients with Maxillary or Bimaxillary Dentoalveolar Protrusion: A Systematic Review and Meta-analysis. J Contemp Dent Pract. 2019 Jan 1;20(1):113-127.

  PMID: 31058623 BACKGROUND

• Alfawal AMH, Hajeer MY, Ajaj MA, Hamadah O, Brad B, Latifeh Y. Evaluation of patient-centered outcomes associated with the acceleration of canine retraction by using minimally invasive surgical procedures: A randomized clinical controlled trial. Dent Med Probl. 2020 Jul-Sep;57(3):285-293. doi: 10.17219/dmp/120181.

  PMID: 32909702 BACKGROUND

• Gibreal O, Hajeer MY, Brad B. Evaluation of the levels of pain and discomfort of piezocision-assisted flapless corticotomy when treating severely crowded lower anterior teeth: a single-center, randomized controlled clinical trial. BMC Oral Health. 2019 Apr 16;19(1):57. doi: 10.1186/s12903-019-0758-9.

  PMID: 30991984 BACKGROUND

• Khlef HN, Hajeer MY, Ajaj MA, Heshmeh O, Youssef N, Mahaini L. The effectiveness of traditional corticotomy vs flapless corticotomy in miniscrew-supported en-masse retraction of maxillary anterior teeth in patients with Class II Division 1 malocclusion: A single-centered, randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2020 Dec;158(6):e111-e120. doi: 10.1016/j.ajodo.2020.08.008. Epub 2020 Nov 4.

  PMID: 33158633 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class II; Pain

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hanin Nizar Khlef, DDS,MSc

  Specialist and Clinical Lecturer, Department of Orthodontics, University of Damascus

  PRINCIPAL INVESTIGATOR

• Mohammad Y Hajeer, DDS,MSc,PhD

  Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria

  STUDY CHAIR

• Omar Heshmeh, DDS,MSc,PhD

  Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus, Syria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 10, 2021
• Study Start: February 15, 2018
• Primary Completion: July 31, 2018
• Study Completion: May 15, 2019
• Last Updated: September 10, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)