| CTRI Number |
CTRI/2025/01/079375 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study to find out the effect of piezocision procedure on the speed of movement of forwardly placed lower jaw teeth during fixed braces treatment |
|
Scientific Title of Study
|
Evaluation of rate of tooth movement during en-masse distalisation of mandibular teeth with and without Piezocision for correction of Angle’s Class III Malocclusion - A Randomized Clinical trial. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akshaya k |
| Designation |
Post Graduate student |
| Affiliation |
SRM dental college |
| Address |
SRM Institute of Science and Technology, Department of orthodontics, SRM dental college, No.30, Bharathi Salai, Ramapuram
Chennai
TAMIL NADU
600089
India |
| Phone |
8939037205 |
| Fax |
|
| Email |
akshayakothandaraman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeetha Duraisamy |
| Designation |
Professor |
| Affiliation |
SRM dental college |
| Address |
SRM Institute of Science and Technology, Department of orthodontics, SRM dental college, No.30, Bharathi Salai, Ramapuram
Chennai
TAMIL NADU
600089
India |
| Phone |
9789000386 |
| Fax |
|
| Email |
sangeetha.guhan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangeetha Duraisamy |
| Designation |
Professor |
| Affiliation |
SRM dental college |
| Address |
SRM Institute of Science and Technology, Department of orthodontics, SRM dental college, No.30, Bharathi Salai, Ramapuram
Chennai
TAMIL NADU
600089
India |
| Phone |
9789000386 |
| Fax |
|
| Email |
sangeetha.guhan@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics, Room no. 9, second floor, SRM dental college,
No. 30, Bharathi Salai, Ramapuram, Chennai 600089, Tamil Nadu, India
|
|
|
Primary Sponsor
|
| Name |
Akshaya. K |
| Address |
SRM Institute of science and technology Department of orthodontics, SRM dental college, No. 30, Bharathi Salai, Ramapuram, Chennai 600089, Tamil Nadu, India |
| Type of Sponsor |
Other [Self Sponsoring] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Akshaya K |
SRM Dental College |
SRM Institute of science and technology, Department of orthodontics, SRM dental college, No. 30, Bharathi Salai, Ramapuram, Chennai 600089
Chennai
TAMIL NADU |
8939037205
akshayakothandaraman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRMDCIRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group: Enmasse distalisation of mandibular teeth withbout Piezocision |
Control group:The enmasse distalisation will be initiated in 19X25 SS with stamped brass hooks in 0.022-inch slot MBT Prescription brackets (Mini Diamond, Ormco corporation, Columbia USA) following extraction of third molars if present. Anchorage will be obtained from stainless steel orthodontic mini-implants (SK surgicals) of 2mm diameter and 8mm or 10 mm length placed in buccal shelf of the mandible on right and left side using NiTi closed coil springs (metro, D-tech ortho) (350g of force on each side) |
| Intervention |
Experimental group: Piezocison followed by en-masse distalisation of mandibular teeth |
Experimental group: Piezocision Corticotomy under local anaesthesia will be performed before activating the retraction. The patients will be asked to rinse with 0.12% chlorhexidine for 1 minute and the surgical area will be cleaned with a gauze soaked in chlorhexidine. Vertical interproximal incisions of 10mm length will be made 4mm below the interdental papilla on the buccal aspect of mandible, mesial to first molars, mesial and distal to canines bilaterally using a No. 15 blade. These incisions will provide access to Piezocision knife (BS1, Acteon) used for alveolar decortication to a length of 5 to 8mm and depth of about 3mm. The depth will be verified with millimetric signs on the Piezocision knife or Goldman- Fox probe. Post surgical instructions on diet, hygiene maintenance and post operative medications (antibiotics and anti-inflammatory drugs) will bw given. The enmasse distalisation will be initiated in 19X25 SS with stamped brass hooks in 0.022-inch slot MBT Prescription brackets (Mini Diamond, Ormco corporation, Columbia USA) following extraction of third molars if present. Anchorage will be obtained from stainless steel orthodontic mini-implants (SK surgicals) of 2mm diameter and 8mm or 10 mm length placed in buccal shelf of the mandible on right and left side using NiTi closed coil springs (metro, D-tech ortho) (350g of force on each side). |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing fixed orthodontic treatment and enmasse retraction of mandibular teeth with skeletal anchorage for correction of Angle’s class III Malocclusion.
2. Patients with good oral hygiene, good periodontal and gingival health and with no history of systemic diseases.
3. Patients who aren’t under any medication that can affect bone biology |
|
| ExclusionCriteria |
| Details |
1.Patients with Mal-occlusion other than Class III.
2.Patients on antibiotics, anti- inflammatory or steroidal drugs.
3.Patients with pre-existing psychiatric or those undergoing psychiatric therapy.
4.Patients with any congenital cranio- facial anomaly, or those affected by cranio-facial syndromes.
5. Patients who did not consent to participate in this study or those not willing to undergo Piezocision procedure
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of retraction during en mase distalisation in class III malocclusion |
Prior to initiation of enmasse distalisation of mandibular teeth and after achievement of class 1 molar relationship |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Axial inclination of mandibular central incisors
2. Root resorption of mandibular teeth
3. Pain perception
4. Gingival status
5. Soft tissue healing
6. Pulp vitality
|
1. Prior to initiation of enmasse distalisation of mandibular teeth and After achievement of class 1 molar relationship
2. Prior to initiation of enmasse distalisation of mandibular teeth and After achievement of class 1 molar relationship
3. 24 hours, 3rd day, 7th day and 14th day after implant placement and piezocision
4. Prior to initiation of enmasse distalisation of mandibular teeth and After achievement of class 1 molar relationship
5. 3rd day, 7th day and 14th day after implant placement and piezocision
6. Prior to initiation of enmasse distalisation of mandibular teeth and after achievement of class 1 molar relationship |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
07/02/2025 |
| Date of Study Completion (India) |
16/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomised controlled trial evaluating the efficiency of piezocision on the rate of tooth movement during enmasse distalisation of mandible during class III correction. 2 groups of patients will be included in the study (experimental and control group). Prior to retraction pre op CBCT will be taken for both the groups. Patients in the experimental group will undergo piezocision corticotomy. Vertical interproximal incisions of 10mm length will be made 4mm below the interdental papilla on the buccal aspect of mandible, mesial to first molars, mesial and distal to canines bilaterally post which Piezocision knife will be used for alveolar decortication to a length of 5 to 8mm and depth of about 3mm. Anchorage will be obtained from stainless steel orthodontic mini-implants of 2mm diameter and 8mm or 10 mm length placed in buccal shelf of the mandible on right and left side using NiTi closed coil springs in both the groups. Post op CBCT will be taken for both the groups post class 1 molar achievement. Primary outcome will be to analyse the rate of tooth movement during enmasse distalisation in correction of class III Malocclusion. Secondary outcomes include, Axial inclination of mandibular central incisors, Root resorption of mandibular teeth, Pain perception, Gingival status, soft tissue healing and, Pulp vitality. |