| CTRI Number |
CTRI/2026/01/100512 [Registered on: 07/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effects of Micro-Osteoperforations Following Placement of Blood Concentrates on the Rate of Maxillary Canine Retraction and the Expression of Various Biomarkers in Gingival Crevicular Fluid During Comprehensive Orthodontic Treatment |
|
Scientific Title of Study
|
Effects of Mini-Screw Implant–Assisted Micro-Osteoperforations Following Placement of Autologous Leukocyte-Platelet-Rich Fibrin on the Rate of Maxillary Canine Retraction and the Expression of Various Biomarkers in Gingival Crevicular Fluid During Comprehensive Orthodontic Treatment: A Split-Mouth 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 |
Dhruvi Rayththa |
| Designation |
Junior resident (academic) |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
1st floor .Department of dentistry, AIIMS, Sijua, Patrapada, Po: Dumduma Bhubaneswar, Orissa-751019
Khordha
ORISSA
751019
India |
| Phone |
|
| Fax |
|
| Email |
drayththa5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jitendra Sharan |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
1st floor, Department of dentistry, AIIMS, Sijua, Patrapada, Po: Dumduma Bhubaneswar, Orissa-751019
Khordha
ORISSA
751019
India |
| Phone |
9968856761 |
| Fax |
|
| Email |
dent_jitendra@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Jitendra Sharan |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
1st floor .Department of dentistry, AIIMS, Sijua, Patrapada, Po: Dumduma Bhubaneswar, Orissa-751019
Khordha
ORISSA
751019
India |
| Phone |
9968856761 |
| Fax |
|
| Email |
dent_jitendra@aiimsbhubaneswar.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences |
| Self |
|
|
Primary Sponsor
|
| Name |
Dhruvi Rayththa |
| Address |
1st floor, Department of dentistry, AIIMS, Sijua, Patrapada, Po: Dumduma Bhubaneswar, Orissa-751019 |
| 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 Dhruvi Rayththa |
All India Institute of Medical Sciences, Bhubaneswar |
1st floor .Department of dentistry, AIIMS, Sijua, Patrapada, Po: Dumduma Bhubaneswar, Orissa-751019
Khordha
ORISSA |
7069438738
drayththa5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,AIIMS BHUBANESWAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M264||Malocclusion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Leukocyte-platelet-rich fibrin placement |
Placement of leukocyte-platelet-rich fibrin plug in the extraction socket on the right and left of the dental arch |
| Intervention |
Leukocyte-platelet-rich fibrin placement and micro-osteoperforation |
Placement of leukocyte-platelet-rich fibrin plug in the extraction socket on the right and left of the dental arch, followed by micro-osteoperforation on one of the sides of the dental arch after 1 month. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1)Subjects having Class I bimaxillary dentoalveolar protrusion malocclusion or Class II div 1 malocclusion with normodivergent growth pattern (FMA 20–28), minimum spacing, or crowding (2–5 mm) in maxillary and mandibular arches require either all 1st premolar extraction or only upper 1st premolar extraction for the correction of their malocclusion.
2)Presence of a full complement of teeth except for the third molar.
3)Good oral hygiene(gingival index score less than 1, probing depth less than 3mm) |
|
| ExclusionCriteria |
| Details |
1)History of complete or incomplete comprehensive orthodontic treatment
2)Subject who fails to maintain proper oral hygiene all through the orthodontic treatment
3)Subjects with pregnancy
4)Subjects with any known syndrome
5)Subjects with any calcium and phosphate metabolism affecting disorder
6)Subjects on long-term medication like NSAIDs or steroids
7)Lack of manual dexterity
8)Any medications for a systemic illness
9)History of recent bacterial or viral infection
10)Known blood disorders like thrombocytopenia, leukopenia, etc. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effects of micro osteoperforation following placement of L-PRF plug on the rate of canine retraction during comprehensive orthodontic treatment. |
T0- 0 DAY
T1- 30TH DAY
T2- 45TH DAY
T3- 60TH DAY
T4- 75TH DAY
T5- 90TH DAY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To assess the effects of micro-osteoperforation following placement of L-PRF plug on the concentration of various biomarkers in the GCF during the comprehensive orthodontic treatment.
2)To correlate the concentration of biomarkers (OPG, RANKL) with the rate of canine retraction in patients who underwent micro-osteoperforation following placement of L-PRF plug. |
T0- 0 DAY
T1- 30TH DAY
T2- 45TH DAY
T3- 60TH DAY
T4- 75TH DAY
T5- 90TH DAY |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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 |
|
Date of First Enrollment (India)
|
21/01/2026 |
| 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="0"
Months="3"
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
|
The extended period for orthodontic treatment is troublesome for adult patients for aesthetic and social reasons. Thus, orthodontists are constantly looking for ways to accelerate orthodontic tooth movement reducing the treatment duration. Adults show lagging cell mobilisation rates and irregular collagen fiber arrangement and are more prone to periodontal diseases as compared to younger patients. Therefore, shortening the duration of treatment by hastening the tooth movement is challenging for orthodontists. Two types of treatment modalities are available to accelerate the rate of orthodontic tooth movement, i.e., surgical and non-surgical, which can be invasive or non-invasive. Micro-osteoperforations and L-PRF plugs have been used to enhance bone remodeling. The benefits of L-PRF remain for 4 weeks, and micro osteoperforation activates the localised inflammatory pathway, which triggers inflammatory markers leading to osteoclast activation and, ultimately, faster bone remodelling. The sequential use of L-PRF and micro osteoperforations can benefit orthodontic tooth movement. Some studies mentioned the benefits of L-PRF plug and micro osteoperforations on the acceleration of orthodontic tooth movement separately. However, the literature is still lacking in studies that explored the combined effect of micro osteoperforations and L-PRF. Hence, the current research is directed towards evaluating the additional effect of L-PRF and micro osteoperforations on the rate of orthodontic tooth movement and correlating the same with the expression of various biomarkers in GCF during comprehensive orthodontic treatment. |