Evaluation of Treatment Duration of En-masse Versus Two Steps Retraction in Patients Having Maxillary Protrusion

Bimaxillary Protrusion Clinical Trial

Official title:

Evaluation of Treatment Duration of En-masse Versus Two Steps Retraction in Patients Having Maxillary Protrusion: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04921579
• Other study ID #: FUE.REC (23)/11-2019
• Status: Completed
• Phase: N/A
• Start date: December 15, 2019
• Est. completion date: January 21, 2021

Study information

• Verified date: May 2021
• Source: Future University in Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Brief summary: there's a scarcity in literature concerning time needed to retract anterior segment following premolars extraction. the purpose of this study is to determine, in orthodontic patients with maxillary protrusion, which form of technique of retraction offers a faster treatment duration of retraction : en-masse or two step techniques

Description:

Anterior segment retraction can be done in one of two ways: through En masse or two step techniques. Both are viable options, but, ideally, the investigator wanted to retract and complete the orthodontic treatment as quickly as possible, in order to decrease the negative effects that may occur during treatment. Which of these techniques results in a decreased treatment time is still up for debate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 21, 2021
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 24 Years

Eligibility

Inclusion Criteria:

• Adults and adolescent patients ( both gender)

• Age range (14- 24)

• patient with maxillary protrusion requiring first premolars extraction ( bimaxillary protrusion or class II division 1 cases)

• patients with fully erupted permanent teeth ( not necessarily including the third molar).

• cases required maximum anchorage during retraction.

• good general and oral health

Exclusion Criteria:

• patients suffering from any systemic diseases interfering with tooth movement.

• patients with extracted or missing permanent teeth (except for third molars).

• patients with badly decayed teeth.

• patients with any parafunctional habits ( i.e. Bruxism, tongue thrusting, mouth breathing, etc.,.....)

• patients with previous orthodontic treatment

Related Conditions & MeSH terms

• Bimaxillary Protrusion

Intervention

Procedure:
• En masse retraction
Retraction stated on a 0.017''x 0.025'' Stainless steel wire using elastomeric chain ( force applied 200 g per side) extending between the crimpable hooks and the mini-screw.
• Two-Step retraction
Retraction of canine started on a 0.017''x0.025'' Stainless steel wire using elastomeric chain ( force applied 150 g per side) followed by anterior teeth retraction on 0.017''x0.025'' Stainless steel wire using elastomeric chain ( force applied 160 g per side) extending between crimpable hooks and the mini-screw.

Locations

Country	Name	City	State
Egypt	Future University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Future University in Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to close extraction space	the antero-posterior movement of anterior teeth are assessed by monthly taken models and patient record sheets	from pre to post retraction ( an average of 10 - 12 months)
Secondary	Anchorage loss	Digitalized dental models taken before and after completion of retraction will be measured by identifying landmarks and reference lines and planes ( measured in mm)	From pre to post retraction ( an average of 10- 12 months)
Secondary	pain of intervention	Each patient was informed to fill a questionnaire regarding treatment experience in Visual analogue scale scoring from (0 -10) 0 means no pain and 10 means severe pain	From pre to post retraction ( an average of 10 - 12 months)