Root Resorption in Class II Div 1 Malocclusion in Upper 1st Premolar Extraction vs Distalization

NCT05639725 | Unknown DMC

• 1 other identifier: SONAL RAVEENA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Class II Division 1 malocclusion is characterized by upper anterior teeth protrusion resulting in upper lip protrusion and convex facial profile, which are considered esthetically unfavorable. Treatment of class II malocclusion due to maxillary protrusion can be done with bilateral maxillary first premolar extraction followed by en-masse retraction of upper anterior teeth using mini implants placed between maxillary 2nd premolar \& 1st molar. Treatment of class II malocclusion due to maxillary protrusion without premolar extraction frequently requires distalization of maxillary molars into Class I molar relation by means of extra-oral or intraoral forces. Absolute skeletal anchorage, available 24 hours a day is an alternative method for molar distalization. Zygomatic miniplates fixed at a distance from the root apices, allows distalization of entire dentition as there is no interference between the fixation device and roots of the teeth. Aims and Objectives: To quantify root resorption seen with bilateral extraction of maxillary first premolars (followed by en - masse retraction of anterior teeth) vs full arch distalization with zygomatic miniplates in Class II Division I malocclusion. Method of study: Patients will be allocated randomly to 2 groups-G1 and G2. Patients in G1 will undergo bilateral maxillary 1st premolar extraction before bonding followed by leveling \& alignment. Maxillary arch will be stabilized with the help of 0.019"×0.025" stainless steel wire. Hooks will be soldered on archwire used for stabilizing dentition. Mini implants will be placed under local anaesthesia between maxillary 2nd premolar \& 1st molar. Ni-Ti closed coil spring will be used to apply a force for en masse retraction of maxillary anterior teeth . In G2, treatment will be initiated by bonding 0.022" slot MBT preadjusted edgewise appliance. Maxillary arch will be stabilized with the help of 0.019"×0.025" stainless steel wire. Zygomatic miniplates will be placed bilaterally. Hooks will be soldered on archwire used for stabilizing dentition. Ni-Ti closed coil spring will be used to apply a force .

Conditions

Class II Div 1 Malocclusion

Outcome Measures

Primary Outcomes (1)

• 1.To quantify root resorption seen with bilateral extraction of maxillary first premolars (followed by en-masse retraction of anterior teeth) vs maxillary full arch distalization using zygomatic miniplates in Class II division 1 malocclusion.

  pre treatment and post treatment cbct has been assessed to measure the root resorption of maxillary teeth in millimetres 2. To compare both patients' and orthodontist's perceptions of treatment being done in both the groups.

  34 MONTHS

Secondary Outcomes (1)

• patient and orthodontist perception

  34 months

Study Arms (2)

EXTRACTION OF MAXILLARY IST PREMOLARS

EXPERIMENTAL

Experimental: EXTRACTION treatment of class II div 1 malocclusion with bilateral maxillary premolar extraction

Procedure: maxillary Ist premolar extraction

DISTALIZATION

EXPERIMENTAL

Experimental: DISTALIZATION treatment of class II div 1 malocclusion with distalization using zygomatic miniplates

Procedure: SURGICAL

Interventions

maxillary Ist premolar extraction PROCEDURE

Procedure/Surgery: Patients will undergo bilateral maxillary 1st premolars extraction before bonding followed by leveling \& alignment.

EXTRACTION OF MAXILLARY IST PREMOLARS

SURGICAL PROCEDURE

Surgery:After leveling and alignment,placement of zygomatic miniplates in bilaterally

DISTALIZATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non growing patients
• Complete bilateral Class II molar relationship at pre-treatment
• All permanent teeth upto the second molars should be present
• No or minor crowding in the maxillary arch
• Horizontal to average growth pattern.

You may not qualify if:

• Subjects with a history of fixed orthodontic treatment.
• Crossbite
• Vertical growth pattern
• Any systemic disease affecting bone and general growth
• Poor oral hygiene
• Cleft patients
• Patients who fail to follow up or undergo complete treatment

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Sonal Chowdhary

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

DR. SONAL CHOWDHARY, MDS

CONTACT

9992025599; sonalsingla@rediffmail.com

DR.VIRENDER SINGH, MDS

CONTACT

Study Design

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

Study Record Dates

• First Submitted: November 12, 2022
• First Posted: December 6, 2022
• Study Start: June 15, 2021
• Primary Completion: November 30, 2022
• Study Completion: December 15, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IN (1)