Upper jaw expansion with mini-implants with or without tiny bone holes

Phase 1

Recruiting

Conditions: Abnormal findings on diagnostic imaging of skull and head, not elsewhere classified,

Registration Number: CTRI/2019/01/017137

Lead Sponsor: DR MADHURA JAYANT PEDNEKAR

Brief Summary: Mini-implants are successfully used with palatal expanders to work as anchors

and to achieve more efficient skeletal expansion while decreasing undesired dental

effects. Mini-implant Assisted Rapid Palatal Expander (MARPE) shows distribution of

stress throughout the palate while preventing unwanted rotation and tipping of the

maxillary anchor teeth.

Most patients prefer a short orthodontic treatment time. Over the past decade,

the Regional Acceleratory Phenomenon (RAP) induced by surgical trauma has thus

gained emphasis for reducing orthodontic treatment time. This has lead to the

evolution of minimally invasive surgical procedures for inducing RAP for eg. micro

osteoperforation, low level laser therapy etc.

Treixeira et al. have shown that biological principles can be activated to accelerate bone

remodelling using Micro osteoperforation (MOP). In MOP, minute perforations are

created within the bone. Micro osteoperforation increases local levels of inflammatory

cytokine activity around a tooth, which increases bone remodelling by stimulating

osteoclastic activity and causing transient osteopenia. Micro osteoperforation yields

very little discomfort to the patient, can be performed chair side in a few minutes and

can be used in conjunction with any treatment modality including TADs, aligners, etc.

There are sporadic suggestions that MOP can be used in cases where palatal split is not

occurring within first few days of expander activation.

Thus, in this proposed study, we are performing micro osteoperforation, a

minimally invasive technique of accelerated orthodontics in the mid palatal suture

region for Rapid Maxillary Expansion (RME) using miniâ€“implants for skeletal anchorage.

The study intends to compare efficacy of rapid maxillary expansion using miniâ€“implants

with MARPE done with and without MOP. The rationale of this study is that it would

guide clinicians to select the appropriate treatment protocol and achieve optimum

results for their patients

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 22

Inclusion Criteria

1. Subjects in the age group of 18 to 40 years of either gender indicated for skeletal maxillary expansion.
1. Subjects with good oral hygiene.
1. Subjects with healthy periodontal tissues.
1. Subjects with no prior history of orthodontic treatment and/ or orthognathic surgery.
1. Subjects with no severe dentofacial anomalies or syndromic conditions.
1. Subject with no radiographic evidence of bone loss.
1. Subject with no systemic disease or conditions.

Exclusion Criteria

Subjects other than the age group of 18 to 40 years.
1. Subjects without good oral hygiene.
1. Subjects with compromised periodontal tissues.
1. Subjects with prior history of orthodontic treatment and/ or orthognathic surgery.
1. Subjects with severe dentofacial anomalies or syndromic conditions.
1. Subject with radiographic evidence of bone loss.
1. Subject with systemic disease or conditions.
1. Subject with long term use of medications e.g. Antibiotics, phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids, bisphosphonates.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MAXILLARY SKELETAL EXPANSION WITH MINIMAL DENTAL SIDE EFFECTS	TWO MONTHS

Secondary Outcome Measures

Name	Time	Method
LEESER ROOT RESORPTION, LESSER BUCCAL TIPPING, LESSER CHANCES OF BUCCAL BONY FENESTRATION AND DEHISCENCE OF ANCHOR TEETH	TWO MONTHS

Trial Locations

Locations (1): MGM DENTAL COLLEGE AND HOSPITAL
🇮🇳
Raigarh, MAHARASHTRA, India
MGM DENTAL COLLEGE AND HOSPITAL
🇮🇳Raigarh, MAHARASHTRA, India
DR MADHURA JAYANT PEDNEKAR
Principal investigator
9920744907
mjpednekar22@gmail.com