| CTRI Number |
CTRI/2025/07/089952 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
"A Study Comparing Tooth Movement With and Without Muco-periosteal Flap(Gum Flap) Elevation During Orthodontic Treatment in Patients undergoing Tooth Extraction" |
|
Scientific Title of Study
|
Impact of Full-Thickness Mucoperiosteal Flap Elevation on Orthodontic Tooth Movement in Split-Mouth Extraction Cases: An In-Vivo Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devarshi Hingrajia |
| Designation |
MDS Resident |
| Affiliation |
Manubhai Patel Dental College and Hospital |
| Address |
Dept of Orthodontics and Dentofacial Orthopaedics, Manubhai Patel Dental College and Hospital, Vishwajyoti Ashram, Near Vidyakunj School, Mujmahuda, Vadodara
Vadodara
GUJARAT
390011
India |
| Phone |
9664800359 |
| Fax |
|
| Email |
devarshi1201@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpesh Patel |
| Designation |
Head of Dept |
| Affiliation |
Manubhai Patel Dental College and Hospital |
| Address |
Dept of Orthodontics and Dentofacial Orthopaedics, Manubhai Patel Dental College and Hospital, Vishwajyoti Ashram, Near Vidyakunj School, Mujmahuda, Vadodara
Vadodara
GUJARAT
390011
India |
| Phone |
9898107502 |
| Fax |
|
| Email |
dr_kalpeshp@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devarshi Hingrajia |
| Designation |
MDS Resident |
| Affiliation |
Manubhai Patel Dental College and Hospital |
| Address |
Dept of Orthodontics and Dentofacial Orthopaedics, Manubhai Patel Dental College and Hospital, Vishwajyoti Ashram, Near Vidyakunj School, Mujmahuda, Vadodara
Vadodara
GUJARAT
390011
India |
| Phone |
09664800359 |
| Fax |
|
| Email |
devarshi1201@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Orthodontics and Dentofacial Orthopaedics, Manubhai Patel Dental College and Hospital, Vishwajyoti Ashram, Near Vidyakunj School, Mujmahuda, Vadodara |
|
|
Primary Sponsor
|
| Name |
Dr Devarshi Hingrajia |
| Address |
Vraj Bhumi apartment, Jalaram Colony, M.G.Road, Opp ACC Gate, Porbandar, Gujarat 360575 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Devarshi Hingrajia |
Manubhai Patel Dental College and Hospital, Vadodara |
Dept of Orthodontics and Dentofacial Orthopaedics, Manubhai Patel Dental College and Hospital, Vishwajyoti Ashram, Near Vidyakunj School, Mujmahuda, Vadodara, Gujarat
Vadodara
GUJARAT |
09664800359
devarshi1201@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(IEC) FOR RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Orthodontic tooth movement with flap elevation |
Full thickness mucoperiosteal flap(FTMPF) elevation will be done to extract first premolars after initial levelling and alignment on 0.014,0.016 and 0.017x0.025 NiTi archwires immediately followed by enmass retraction using NiTi closed coil spring on 0.019x0.025 SS archwire during fixed orthodontic therapy.
Impression will be taken at monthly interval for four months to evaluate the amount of space closure.
(Flap design: Canine root length will be assessed on an OPG. A sulcular incision will be made from the second premolar to the canine, avoiding the eminence. A trapezoidal full-thickness flap will be raised. Palatal mucosa will be tunnelled, and the first premolar will be extracted. The site will be irrigated and closed with 3-0 silk sutures.) |
| Comparator Agent |
Orthodontic tooth movement without flap elevation |
Conventional extraction technique will be used to extract first premolars after initial levelling and alignment on 0.014,0.016 and 0.017x0.025 NiTi archwires immediately followed by enmass retraction using NiTi closed coil spring on 0.019x0.025 SS archwire during fixed orthodontic therapy.
Impression will be taken at monthly interval for four months to evaluate the amount of space closure. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients who give consent for the study.
Patients requiring fixed orthodontic treatment.
Good oral hygiene and healthy periodontium before starting the treatment.
No history of previous orthodontic treatment.
All of the permanent dentition present excluding third molars.
Cases indicated for extraction of the maxillary first premolars and canine retraction into the extraction space with maximum anchorage.
Malocclusion cases that allow initial stage of leveling and alignment without extraction.
Patients without syndromes affecting the cranial region or any craniofacial injuries present.
|
|
| ExclusionCriteria |
| Details |
Patients with systemic diseases like Diabetes mellitus, especially bleeding disorders and osteoporosis.
Patients with history of administration of corticosteroids, immunosuppressants, exogenous hormones and other non-steroidal anti-inflammatory drugs (all drugs interfering with OTM).
Patients with previous history of oral surgeries in maxillary arch.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate and compare rate of space closure after maxillary first premolar extraction with and without full thickness mucoperiosteal flap elevation. |
Impression will be taken at baseline, after 1 month, after 2 months, after 3 months and at 4th month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="31"
Sample Size from India="31"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This will be a split-mouth study. Thirty-one patients undergoing orthodontic treatment will be selected. Each participant will be treated using a fixed pre-adjusted appliance with a metal 0.022 x 0.028” slot MBT prescription bracket system. Detailed information about the study will be provided, and written informed consent will be obtained. Study Phases: Phase I – Initial Orthodontic Phase:
Orthodontic bonding and banding will be performed. Levelling and alignment will be done using 0.014" and 0.016" NiTi archwires, followed by 0.019 x 0.025" NiTi wires. Maxillary first premolars will be extracted after alignment. Allocation Method:
In each patient, one side of the maxillary arch will be randomly designated as the experimental side and the opposite as control. The experimental side will be selected by lottery for the first patient, and then alternated for the rest. Phase II – Surgical Intervention:
Control side extraction will be done three days before the test side. On the experimental side, after local anesthesia, a trapezoidal FTMPF will be raised in the canine-premolar region using a No. 15 blade and Molt No. 9 elevator. A sulcular incision will be made from the mesial of the second premolar to the mesial of the canine, avoiding the canine eminence. Palatal mucosa will be elevated using a tunneling technique. First premolars will be extracted on both sides using premolar forceps. The sockets will be irrigated with saline, and the flap on the test side will be sutured with 3-0 black braided silk. Postoperative Instructions:
Cap. Amoxicillin 500 mg (TID) and Tab. Paracetamol 650 mg (BID) will be given for three days. Patients will be advised to avoid spitting, gargling, and hot/hard foods for one week. Phase III – Retraction Phase:
A 0.019 x 0.025” stainless steel archwire will be inserted on both sides on the same day. En-masse retraction will begin using 12 mm NiTi closed coil springs from the power arm mesial to the canine to the molar tube. Force will be standardized at 150g using a Dontrix gauge. Results:
Canine retraction will be evaluated monthly for four months using study models. The distance moved by the canine will be measured from the cusp tip to a reference plane perpendicular to the occlusal plane just mesial to the first molar, using a Digital Vernier Caliper. |