| CTRI Number |
CTRI/2026/02/102798 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Evaluation And Comparison of Reverse curve of Spee Archwire with Anterior Bite Plane in Patients Undergoing Treatment of Deep Bite |
|
Scientific Title of Study
|
EVALUATION AND COMPARISON OF REVERSE CURVE OF SPEE ARCHWIRE WITH ANTERIOR BITE PLANE IN PATIENTS UNDERGOING TREATMENT OF DEEP BITE |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhishek agale |
| Designation |
PG student |
| Affiliation |
rural dental college |
| Address |
Department of Orthodontics 302 Rural Dental college,loni
Department of Orthodontics 302 Rural Dental college,loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
08530161607 |
| Fax |
|
| Email |
abhiagale299@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Shubhangi mani |
| Designation |
Professor |
| Affiliation |
rural dental college |
| Address |
Department of Orthodontics 302,rural dental college,loni
Rural dental college
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
08530161607 |
| Fax |
|
| Email |
drshubhangimani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhishek agale |
| Designation |
PG student |
| Affiliation |
rural dental college |
| Address |
department of orthodontics 302,rural dental college,loni
department of orthodontics 302,rural dental college,loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
8530161607 |
| Fax |
|
| Email |
abhiagale299@gmail.com |
|
|
Source of Monetary or Material Support
|
| pravara institue of medical sciences,loni |
|
|
Primary Sponsor
|
| Name |
pravara institute of health sciences loni |
| Address |
pravara institute of health sciences, loni 413736 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Abhishek agale |
Department of Orthodontics 302,Rural Dental College,loni |
Department of Orthodontics 302,Rural Dental College,loni
Ahmadnagar
MAHARASHTRA |
8530161607
abhiagale299@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, PRAVARA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
deep overbite malocclusion |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
anterior bite plane |
anterior bite plane is made up up of acrylic which is placed on palatal surface between upper canines |
| Intervention |
anterior bite plane with reverse curve of spee |
anterior bite plane is used for deepbite correction,use of reverse curve of spee enhances deepbite correction
t0-baseline
t1-3months
t2-6months |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with horizontal growth pattern.
2.patients with increased overbite (more than half of the lower incisors)
3.No missing or extracted teeth in the lower arch except for third molars.
4.patients whose treatment plan did not include extraction of lower teeth and/or any extrusive mechanics (headgear, functional appliance, expansion appliance, and intermaxillary elastics).
5.Adult patient from 13-30 years of age.
6.Patient who is ready to give written informed consent
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary purpose of this study was to compare two modalities of deep overbite treatment:Anterior bite plane and Anterior bite plane with 0.016 X 0.022- inch (SS) LRCA and their effect on changes in inclination of lower incisors and upper incisors and angular and vertical changes of lower incisors, molars, and premolars. |
t0-baseline
t1-3months
t2-6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes were assessment of sagittal and vertical skeletal changes, to measure the change in the inclination of upper incisors and vertical changes of upper posterior and anterior teeth, and to compare the treatment duration between the two treatment modalities |
t0-baseline
t1-3months
t2-6months |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
18/02/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Deep bite is one of the most commonly encountered vertical malocclusions in orthodontic practice and frequently presents in association with other malocclusions such as Angle’s Class II relationships, crowding, or increased overjet. From a clinical perspective, deep bite is regarded as one of the most potentially damaging malocclusions because of its adverse effects on the masticatory apparatus, temporomandibular joint, dental hard tissues, and periodontal support structures.The excessive vertical overlap may involve a localized group of teeth or extend to the entire dentition and may have contributions from dentoalveolar structures, basal bones of the maxilla and mandible, as well as associated soft tissues. Hence, the correction of deep bite represents a complex orthodontic problem that necessitates comprehensive diagnosis and individualized treatment planning |