Use of osteo-perforations for faster mandibular anterior decrowding.

Phase 3

Completed

• Conditions: Dental malocclusion with lower anterior crowding

• Registration Number: CTRI/2017/11/010610
• Lead Sponsor: Intramural Research Grant from University budget

Brief Summary

**Title :Effects of Transmucosalmicro osteo-perforations on the rate of alleviating mandibular anterior crowding: A Randomized controlled clinical study**

**Rationale**: The ability toaccelerate the tooth movements would be advantageous for orthodontists becausetreatment duration has been linked to an increased risk of gingivalinflammation, decalcification, dental caries and especially root resorption.Ofthe various methods used for accelerating orthodontic tooth movement, surgicalapproaches (alveolar decortications or corticotomies) has shown the mostpromising and consistent results but are associated with postsurgicalmorbidity(swelling, pain). Micro-osteoperforation is a minimally invasivetechnique which is an effective, comfortable, and safe procedure to acceleratetooth movement.

Ø  **Aimsand Objectives**: To evaluate the effect of transmucosal micro-osteoperforationson the rate of alignment of mandibular anterior teeth as compared to conventional orthodontic group.

Alsoto compare the time required to achievealignment, subject’s perception of pain, comfort , satisfaction, marginal boneheight and apical root resorption around mandibular anterior teeth between thetwo procedures.

**Setting**: Department ofOrthodontics and Dentofacial Orthopaedics, PGIDS, Rohtak.

**Study Design:** Randomized controlledclinical trial

**Time frame:** 08-12 months

**Population/participant** : *Inclusion criteria*:- Moderate crowdingcases,15-25 yrs of age,single or double arch, non-extraction treatment in themandibular arch,no spaces in the mandibular arch and healthyperiodontium

.*Exclusion Criteria*:-Failureto provide oral and written consent to participation,medical problems thataffect tooth movement,presence of primary teeth in the mandibular anteriorarea,missing permanent mandibular anterior teeth,presence of any signs andsymptoms of gingival and periodontal diseases,evidence of bone loss.

**Sample  size** – a sample size of 28 patientswith fourteen patients in each group.

**Methods**- Patients who met theinclusion criteria will be randomly assigned to the control and experimentalgroups. Treatment will be initiated by bonding 0.022†slot MBTstraight wire appliance. The main intervention in this clinical study is toperform six transmucosal micro-osteoperforations(MOPs), two MOPs eachinterproximally between mandibular canine and lateral incisor and betweencentral incisors on labial aspect of mandible(in a vertical line).

**Outcome Measures**– The primary outcome variables will be to compare rate of  alignment of crowded mandibular anterior teeth (canine to canine). Secondarywill be

Ø To compare timerequired to achieve alignment.

Ø To compare subject’s perception ofpain,comfort and satisfaction using questionnaires

Ø To compare the marginal bone height andapical root resorption through CBCT.

**StatisticalAnalysis**:Data will be checked for normality. If normally distributed then student ttest will be applied for non related variables and paired t test will be forrelated variables. If not normally distributed then mann- whitney test will beapplied for non related variables and wilcoxon signed rank test for relatedvariables. Categorical data will beanalyzed using chi-square test and wilcoxon signed rank test.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-15
• Study Completion: 2018-08-19
• Last Update Posted: 2019-06-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1-Mandibular anterior irregularity index upto 6 mm 2-Single arch or double arch treatment 3-Non extraction treatment in the mandibular arch 4-Presence of full complement dentition from first molar to first molar 5-No spaces in the mandibular arch 6-Patient with healthy periodontium and no attachment loss of greater than 2 mm 7-The amount of crowding should allow for bracket placement 8-No therapeutic intervention planned involving intermaxillary or other intraoral or extraoral appliances including elastics, lip bumpers, maxillary expansion appliances or Headgear prior to the complete alignment of mandibular anterior teeth.

Exclusion Criteria

1- Failure to provide oral and written consent to participation 2-Medical problems that effect tooth movement 3-Presence of primary teeth in the mandibular anterior area 4-Missing permanent mandibular anterior teeth 5-Inability to place bracket in the mandibular anterior teeth 6-Breakage of any of the mandibular anterior brackets that have not been replaced within a week 7- Presence of any signs and symptoms of gingival and periodontal diseases 8-Evidence of bone loss.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of transmucosal micro osteo-perforations on the rate of alignment of mandibular anterior teeth as compared to conventional orthodontics group.	6 MONTHS

Secondary Outcome Measures

Name	Time	Method
1-To compare the time required to achieve alignment of crowded mandibular anterior teeth	2-To compare subject’s perception of pain, comfort and satisfaction using two

Trial Locations

Locations (1)

Post Graduate Institute of Dental Sciences, Rohtak; 🇮🇳 Rohtak, HARYANA, India

Post Graduate Institute of Dental Sciences, Rohtak

🇮🇳Rohtak, HARYANA, India

Mehak Bansal

Principal investigator

9953902553

mehakbansal420@gmail.com