Evaluation of Upper Anterior Teeth Retraction Rate Assisted by Two Corticotomy Techniques

NCT04847492 | Completed DMC

• 1 other identifier: UDDS-Ortho-03-2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the dental changes, periodontal health and the pulp vitality in mini-screw supported en-masse retraction associated with traditional or flapless corticotomy techniques. 40 adult patients exhibiting class II division 1 malocclusion requiring upper first premolar extractions followed by en-masse retraction will participate in the study. They will be randomly and equally distributed into two groups: traditional corticotomy (20 patients) versus flapless corticotomy (20 patients). The corticotomy procedure will be performed pre-retraction. The dental changes will be assessed using dental casts. The impressions will be taken after finishing the leveling and alignment phase and before starting the en-masse retraction (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), and 5 months (T5) following the onset of en-masse retraction. The final impression will be considered at the end of the en-masse retraction (when the canines reach Class Ι relationship).

Conditions

Class II Division 1 Malocclusion

Keywords

En-masse; retraction; corticotomy; flapless; miniscrew; upper anterior teeth

Outcome Measures

Primary Outcomes (4)

• The rate of en-masse retraction of upper anterior teeth.

  The rate of en-masse retraction of upper anterior teeth (mm/month) in each group will be calculated. This outcome will be measured by the following steps: Drawing a projection from the upper canine apex to the middle palatal bone line. Drawing a projection from the upper central incisor edge to the middle palatal bone line. Drawing a projection from the mesial ending of the third palatal rugae to the middle palatal bone line. Measuring the distance (mm) between the canine apex and third palatal rugae projections. Measuring the distance (mm) between the central incisor edge and third palatal rugae projections. The rate of en-masse retraction will be measured by dividing the distance between the canine apex/central incisor edge projections and the third palatal rugae projection by the time elapsed between assessment times.

  The calculation of the rate of retraction will be done once the retraction procedures finish. It is expected to happen within 5 months

• Change in the anteroposterior movement of the molar at 5 months

  The anteroposterior movement of the molar (mm/month) in each group will be calculated. This outcome will be measured on the dental casts by drawing two projections from the central groove of the first maxillary molar and the mesial ending of the third palatal rugae to the middle palatal bone line. The anteroposterior movement of the first maxillary molar (mm) will be measured by dividing the distance between the two projections by the time elapsed between assessment times.

  T0:1 day before the beginning of the retraction phase. T1: after 1 month of the beginning of retraction phase . T2: after 2 months. T3: after 3 months. T4: after 4 months. T5: immediately after the end of retraction phase (expected to be after 5 months)

• Change in the inter-canine width at 5 months

  The change in the inter-canine width (mm/month) in each group will be calculated. Assessment will be performed by measuring the distance between the cusp tips of the two upper canines. This variable will be measured on dental casts.

  T0:1 day before the beginning of the retraction phase. T1: after 1 month of the beginning of retraction phase . T2: after 2 months. T3: after 3 months. T4: after 4 months. T5: immediately after the end of retraction phase (expected to be after 5 months)

• Change in the inter-molar width at 5 months

  The change in the inter-molar width (mm/month) in each group will be calculated. Assessment will be performed by measuring the distance between the the central groove of the two first maxillary molars. This variable will be measured on dental casts.

  T0:1 day before the beginning of the retraction phase. T1: after 1 month of the beginning of retraction phase . T2: after 2 months. T3: after 3 months. T4: after 4 months. T5: immediately after the end of retraction phase (expected to be after 5 months)

Secondary Outcomes (5)

• The change in dental plaque index according to Silness and Loe

  T0: immediately before the start of treatment; T1: one day before the commencement of the retraction phase; T2: immediately after the end of retraction phase (expected to be after 5 months)

• The change in gingival index according to Silness and Loe

  T0: immediately before the start of treatment; T1: one day before the commencement of the retraction phase; T2: immediately after the end of retraction phase (expected to be after 5 months)

• The change in papillary bleeding index according to Muhlemann

  T0: immediately before the start of treatment; T1: one day before the commencement of the retraction phase; T2: immediately after the end of retraction phase (expected to be after 5 months)

• The change in gingival recession index according to Miller

  T0: immediately before the start of treatment; T1: one day before the commencement of the retraction phase; T2: immediately after the end of retraction phase (expected to be after 5 months)

• Tooth vitality

  T0: immediately before the start of treatment; T1: one day before the commencement of the retraction phase; T2: immediately after the end of retraction phase (expected to be after 5 months)

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

A full-thickness mucoperiosteal flap will be elevated including the interdental papilla, and extended from the distal side of the second premolar on the right side to the same position on the left side without performing any vertical releasing incisions. Then, one vertical incision between the roots of upper anterior teeth and two vertical incisions in the site of first premolar extraction will be made by the piezosurgery knife.

Traditional corticotomy

Flapless corticotomy PROCEDURE

Vertical soft-tissue incisions will be made on the buccal and palatal gingiva by using a blade N.15. One incision will be made between the roots of the six upper anterior teeth, and two incisions will be made between the upper canines and the second premolars.

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 (6)

• 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 AM, Hajeer MY, Ajaj MA, Hamadah O, Brad B. Effectiveness of minimally invasive surgical procedures in the acceleration of tooth movement: a systematic review and meta-analysis. Prog Orthod. 2016 Dec;17(1):33. doi: 10.1186/s40510-016-0146-9. Epub 2016 Oct 24.

  PMID: 27696311 BACKGROUND

• Alfawal AMH, Hajeer MY, Ajaj MA, Hamadah O, Brad B. Evaluation of piezocision and laser-assisted flapless corticotomy in the acceleration of canine retraction: a randomized controlled trial. Head Face Med. 2018 Feb 17;14(1):4. doi: 10.1186/s13005-018-0161-9.

  PMID: 29454369 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

• Khlef HN, Hajeer MY. Is It Possible to Achieve Favorable Accelerated Dental Changes with No Periodontal Complications When Retracting Upper Anterior Teeth Assisted by Flapless Corticotomy Compared to Traditional Corticotomy? A Two-Arm Randomized Controlled Trial. ScientificWorldJournal. 2022 Mar 7;2022:4261248. doi: 10.1155/2022/4261248. eCollection 2022.

  PMID: 35295761 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

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

  Associate 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: April 12, 2021
• First Posted: April 19, 2021
• Study Start: June 9, 2017
• Primary Completion: January 1, 2018
• Study Completion: October 15, 2018
• Last Updated: April 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)