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CTRI Number  CTRI/2025/04/084981 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On: 15/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Enzymatic Changes of Fluid in the Gingiva During Accelerated Orthodontic Tooth Movement Following Small Controlled Perforations in the Bone Combined with Electric Toothbrush Use: A Comparative Study to assess increased or decreased tooth movement in patients undergoing orthodontic treatment 
Scientific Title of Study   Enzymatic Evaluation of Gingival Crevicular Fluid During Accelerated Orthodontic Tooth Movement Following Micro-Osteoperforation Combined with Electric Toothbrush Use: A Comparative 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 Arjun K V 
Designation  Post Graduate (Department of Orthodontics and Dentofacial Orthopaedics) 
Affiliation  A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, MANGALORE 
Address  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, MANGALORE.

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7025716591  
Fax    
Email  arjun.24dort05@student.nitte.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mcqueen Mendonca 
Designation  Reader 
Affiliation  A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, MANGALORE 
Address  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, MANGALORE.

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9880705146  
Fax    
Email  drmcqueenmendonca@nitte.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr MS Ravi  
Designation  Professor, Head of Department, Vice Principal 
Affiliation  A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, MANGALORE 
Address  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, MANGALORE.

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845221386  
Fax    
Email  drmsravi@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, MANGALORE. 
 
Primary Sponsor  
Name  Dr Arjun K V  
Address  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, MANGALORE. 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
Professor Dr MS Ravi  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, MANGALORE 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arjun K V   A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, MANGALORE.  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, DERALAKATTE, MANGALORE, DAKSHINA KANNADA, KARNATAKA.
Dakshina Kannada
KARNATAKA 
7025716591

arjun.24dort05@student.nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee ABSMIDS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Dental Malocclusion 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional orthodontic treatment.  Comparing Enzymatic changes in Gingival Crevicular Fluid During Accelerated Orthodontic Tooth Movement Following Micro-Osteoperforation Combined with Electric Toothbrush Use with that of conventional orthodontic treatment. 
Intervention  Micro-Osteoperforation and use of Electric Toothbrush.  Micro-Osteoperforation spaced 1–3 mm apart distal to the canine will be created. These will be placed on both the buccal and palatal sides, as close to the roots as possible, within the extraction space, following the administration of local anesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  24.00 Year(s)
Gender  Both 
Details  Patient belonging to the age group of 18-24 years
Patients requiring extraction of the bilateral maxillary first premolar and distalization of the canine
Overall good health with no systemic conditions
No history of prior orthodontic treatment
Maintains good oral hygiene
Probing depth less than 3 mm
 
 
ExclusionCriteria 
Details  Patients with underlying medical conditions
Individuals on medications that affect bone metabolism
Presence of bone pathology
Ankylosis of the tooth
Non-compliant patients
Poor oral hygiene or inadequate oral care
Fracture of the cortical plate during extraction
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The combined procedure of micro-osteoperforation and the use of electric toothbrush results in a
significantly increased rate of orthodontic tooth movement with minimal adverse dentoalveolar effects compared to that of the conventional methods. 
• The initial sample will be obtained from both sides of the canine region before retraction (T0). Subsequent samples will be collected on day 1 (T1), day 7 (T2), day 14 (T3), day 30 (T4), day 60 (T5) after the start of canine retraction. 
 
Secondary Outcome  
Outcome  TimePoints 
The overall time for orthodontic treatment will be reduced.  24 Months 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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   N/A 
Date of First Enrollment (India)   10/05/2025 
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  

NEED FOR STUDY

 

An increasing number of adult patients are seeking orthodontic treatment to enhance both the appearance of their smile and their masticatory function. One of the major challenges in orthodontics, however, is the treatment duration. As patient expectations evolve, factors like time efficiency and aesthetic concerns have become more significant.

 

In recent years, adjunctive therapies including micro-osteoperforations(MOPs) and vibrational frequency devices such as Electric toothbrush have been explored to accelerate orthodontic tooth movement by modulating the biological processes involved.1,2

 

Previous research has indicated that the levels of various enzymes and proteins fluctuate following the application of orthodontic force.3

 

This study seeks to evaluate the enzymatic activity in gingival crevicular fluid (GCF) during orthodontic treatment, following MOPs combined with the use of an electric toothbrush.

 

The enzymes of interest are alkaline phosphatase (ALP), acid phosphatase (ACP), aspartate aminotransferase (AST), and dentin sialoprotein (DSP) which are involved in various aspects of bone remodelling4  inflammation5, and root resorption6, making them ideal biomarkers for evaluating the biological changes occurring during orthodontic tooth movement.

 

During the treatment procedure, If the levels of bone remodelling enzymes, such as ALP and ACP are elevated but remain within normal limits after the procedure, it would be considered favourable to proceed with that treatment.

 

On the other hand, enzymes like AST, which indicate tissue damage, should stay within normal limits. An elevation in these levels could result in increased inflammation, potentially causing delayed healing and other complications.

 

This study aims to evaluate the response of enzymes to three different treatments: MOPs, electric toothbrush use, and a combined therapy of both. It will also examine how these treatments correlate with the rate and effectiveness of tooth movement.

BACKGROUND: Orthodontic treatment duration remains a major concern for adult patients. Adjunctive methods like micro-osteoperforations and electric toothbrush use may accelerate tooth movement by influencing biological activity.

PURPOSE OF TRIAL: To evaluate the effect of MOPs, electric toothbrush use, and their combination on enzymatic activity in gingival crevicular fluid. The study aims to determine their potential in enhancing the rate of orthodontic tooth movement while maintaining periodontal health

 

CLINICAL SIGNIFICANCE

The clinical significance of this study lies in assessing how the use of MOPs, electric toothbrush and a combination of both affect enzymatic markers in gingival crevicular fluid, potentially accelerating orthodontic tooth movement while preserving periodontal health.

 

The findings could lead to more efficient treatment strategies that enhance treatment outcomes for patients.

AIM OF THE STUDY       

     The aim of this study is to enzymatically evaluate the changes in gingival crevicular fluid during orthodontic tooth movement in patients undergoing MOPs combined with the use of an electric toothbrush.

 

   OBJECTIVES OF THE STUDY

    To evaluate the enzymatic changes in gingival crevicular fluid during orthodontic tooth movement under following conditions:

      Following MOPs only.

     Following MOPs combined with the use of an electric toothbrush.

    Following use of electric toothbrush only.

    Following conventional orthodontic treatment.

 

  To evaluate the enzymatic changes in gingival crevicular fluid during orthodontic tooth movement for the following enzymes:

     Alkaline Phosphatase for bone formation.

    Acid Phosphatase for bone resorption.

    Aspartate Amino Transferase for tissue inflammation.

   Dentin Sialoprotein (a protein) for root resorption.

SOURCE OF DATA


     This study will be a prospective, comparative design involving 32 patients in total, all undergoing conventional fixed orthodontic treatment at the Department of Orthodontics and Dentofacial Orthopaedics, A.B. Shetty Memorial Institute of Dental Sciences, Mangalore.

    The biochemical analysis will be performed at the Research Laboratory, KSHEMA, Nitte Deemed to be University.


METHODOLOGY


   After receiving approval from the institutional ethics committee, informed consent will be obtained from the patients prior to the commencement of the study.

      Patients who require the extraction of maxillary first premolars on both sides of the arch will be included in the study.

     This is a split-mouth study where participants will be randomly assigned to two groups:

a) Group A: Conventional orthodontic treatment combined with bilateral MOPs. Participants will use an electric toothbrush on one side, which is randomly assigned.

b) Group B: Conventional orthodontic treatment without MOPs. Participants will use an electric toothbrush on one side, which is randomly assigned.

    The split-mouth technique is selected to minimize biological variability.

      The method of simple randomization will be followed throughout the study.

   Patients will be instructed to have their premolars extracted prior to the initial stage of levelling and aligning.

      Banding/bonding for both the upper and lower arches will be performed using standard techniques.

     After the initial alignment, maxillary canine retraction will be performed using NiTi closed coil springs with a 0.017×0.025 stainless steel maxillary arch wire.

      A force of 150gm per side will be applied.12

    The necessary anchorage will be established with mini-implants.

      Participants in groups A will undergo the MOPs procedure bilaterally.

      MOPs (micro-osteoperforations) will be performed using commercially available orthodontic mini-implant screws with a diameter of 1.2 mm and a length of 8mm. The screws will be inserted to a depth of 6mm using a hand driver.

     Three MOPs will be created at a depth of 6 mm, spaced 1–3 mm apart, distal to the canine. These will be placed on both the buccal and palatal sides, as close to the roots as possible, within the extraction space, following the administration of local anesthesia.

     No flap will be raised during the procedure.

     Participants in both Group A and Group B will be provided with a standardized 150 Hz electric toothbrush ensuring consistent specifications and obtained from a single manufacturer. They will be instructed to place it against the mesio-labial surface of the experimental canine to deliver mechanical vibrations for at least 5 minutes, three times a day (at an interval of 6 to 8 hours between each application), throughout the study period.13 Participants will be asked to continue their usual orthodontic cleaning routine for the rest of their teeth. A daily usage log will be provided, and participants will be required to submit it during their monthly follow-up visits.

 

SAMPLE COLLECTION


      Gingival crevicular fluid (GCF) will be collected from the maxillary canines.

     Prior to collection, the cheeks will be retracted using a properly sized cheek retractor.

     The targeted gingival area will be gently dried using an air syringe, and each tooth will be isolated with a cotton roll to prevent contamination.

     A calibrated microcapillary tube will be used to collect GCF by positioning the volumetric micropipette extra-crevicularly and standardized volume of GCF will be collected at various time points.14

     The initial sample will be obtained from both sides of the canine region before retraction (T0). Subsequent samples will be collected on day 1 (T1),  day 7 (T2), day 14 (T3), day 30 (T4), day 60 (T5) after the start of canine retraction.


SAMPLE PREPARATION


     100 µL of phosphate-buffered saline (pH 7) containing 0.05% bovine serum albumin (Sorensen’s medium) will be transferred into a vial using a 100 µL micropipette.

    The volume of buffer added will be 100 times the amount of GCF collected.

    The vial containing the GCF will be sealed, labelled, and immediately sent to the laboratory for centrifugation to remove any bacterial or cellular debris. The centrifugation will be done for 1 minute.

  After centrifugation, the supernatant will be carefully separated and stored in a deep freezer at -80°C for subsequent analysis.

      The collected samples will be analysed for the following enzymes and proteins:

                        I.         Alkaline Phosphatase (Spectro-photometry method)

                      II.         Acid Phosphatase (Spectro-photometry method)

                    III.         Aspartate Aminotransferase (Spectro-photometry method)

                   IV.         Dentin Sialoprotein (ELISA method)

     The data will be analysed and compared across the groups to assess differences in outcomes.

 
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