Comparative Evaluation of Maxillary Skeletal Expansion using Mini-implant Assisted Rapid Palatal Expander with and without Micro osteoperforation in the Mid Palatal Suture region: A Randomized Clinical Trial.
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- MAXILLARY SKELETAL EXPANSION WITH MINIMAL DENTAL SIDE EFFECTS
Study Overview
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 mini–implants for skeletal anchorage.
The study intends to compare efficacy of rapid maxillary expansion using mini–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
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects in the age group of 18 to 40 years of either gender indicated for skeletal maxillary expansion.
- •Subjects with good oral hygiene.
- •Subjects with healthy periodontal tissues.
- •Subjects with no prior history of orthodontic treatment and/ or orthognathic surgery.
- •Subjects with no severe dentofacial anomalies or syndromic conditions.
- •Subject with no radiographic evidence of bone loss.
- •Subject with no systemic disease or conditions.
Exclusion Criteria
- •Subjects other than the age group of 18 to 40 years.
- •Subjects without good oral hygiene.
- •Subjects with compromised periodontal tissues.
- •Subjects with prior history of orthodontic treatment and/ or orthognathic surgery.
- •Subjects with severe dentofacial anomalies or syndromic conditions.
- •Subject with radiographic evidence of bone loss.
- •Subject with systemic disease or conditions.
- •Subject with long term use of medications e.g. Antibiotics, phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids, bisphosphonates.
Outcomes
Primary Outcomes
MAXILLARY SKELETAL EXPANSION WITH MINIMAL DENTAL SIDE EFFECTS
Time Frame: TWO MONTHS
Secondary Outcomes
- LEESER ROOT RESORPTION, LESSER BUCCAL TIPPING, LESSER CHANCES OF BUCCAL BONY FENESTRATION AND DEHISCENCE OF ANCHOR TEETH(TWO MONTHS)