| CTRI Number |
CTRI/2025/11/097659 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A Study comparing the effects of mini screws and curved archwires in treating Deep Bite Cases in 18 patients |
|
Scientific Title of Study
|
A COMPARATIVE STUDY BETWEEN THE EFFECT OF MINI IMPLANTS AND ACCENTUATED COMPENSATING CURVE ARCH-WIRES IN THE TREATMENT OF DEEP BITE CASES
|
| 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 Anagha |
| Designation |
PG student |
| Affiliation |
KVG Dental College and Hospital Sullia |
| Address |
KVG Dental College and Hospital Room no 7 Department of Orthodontics and Dentofacial Orthopaedics Kurunjibhag Sullia
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
7019638050 |
| Fax |
|
| Email |
anagharaao@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sharath Kumar Shetty |
| Designation |
Professor and HOD |
| Affiliation |
KVG Dental College and Hospital Sullia |
| Address |
KVG Dental College and Hospital Room no 7 Department of Orthodontics and Dentofacial Orthopaedics Kurunjibhag Sullia
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
9448300500 |
| Fax |
|
| Email |
orthdeptkvgdc@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sharath Kumar Shetty |
| Designation |
Professor and HOD |
| Affiliation |
KVG Dental College and Hospital Sullia |
| Address |
KVG Dental College and Hospital Room no 7 Department of Orthodontics and Dentofacial Orthopaedics Kurunjibhag Sullia
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
9448300500 |
| Fax |
|
| Email |
orthdeptkvgdc@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Anagha |
| Address |
KVG Dental College and Hospital Room no 7 Department of Orthodontics and Dentofacial Orthopaedics Kurunjibhag Sullia |
| 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 Anagha |
K.V.G Dental College and Hospital |
Department of Orthodontics and Dentofacial Orthopaedics, K.V.G Dental College and Hospital, Sullia Dakshina Kannada KARNATAKA |
7019638050
anagharaao@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee KVG Dental College and Hospital Sullia |
Approved |
| Institutional Ethics Committee KVG Dental College and Hospital Sullia |
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 |
Accentuated compensating curve archwires |
To estimate the intrusion of maxillary anterior teeth by accentuated
compensatory curve arch wires in a period of 3 months. |
| Intervention |
Mini implant |
To estimate the intrusion of maxillary anterior teeth by mini-implants in a period of 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Class I or class II malocclusion, with supra-eruption of the maxillary incisors
2. Excessive gingival display when smiling
3. An overbite , of more than 4mm
4.Good periodontal status and oral hygiene |
|
| ExclusionCriteria |
| Details |
1.Missing teeth in maxillary anterior dentition. 2.Medical contraindications for orthodontic treatment
3.Presence of root resorption in maxillary anterior teeth
4.History of previous orthodontic treatment.
5.History of trauma in maxillary anterior teeth
6.Excess bone loss in upper anterior teeth |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
To compare the effectiveness of mini-implants and accentuated compensating
curve arch wires during maxillary anterior intrusion in treatment of deepbite |
Before and after intrusion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 3 |
|
Date of First Enrollment (India)
|
30/11/2025 |
| 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="1" Months="5" 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
|
Overbite, the vertical
overlap of incisors, is often expressed as the percentage of the lower incisor
crown length that is covered by the upper incisors.
It is characterized by an enhanced vertical overbite and an excessive distance
between the upper and lower teeth’s incisal edges. Based on the underlying
cause, deep bite is divided into two categories: dental deep bite and skeletal
deep bite. However, little research has been done on the different elements of
a deep bite malocclusion and how much each contributes to the issue.Depending on the patient’s unique needs and
the extent of the issue, there are several approaches to repair deep bite.
Accurate diagnosis and meticulous treatment planning are critical to a
successful outcome.One goal of
orthodontic therapy is to correct deep overbite, which is connected to
occlusion stability. Treatment options for deep overbite malocclusions are
numerous. These techniques include fixed appliances and detachable appliances,
both with and without orthognathic surgery. Intractable treatment options
include posterior segment extrusion, incisor proclination, incisor intrusion,
or a combination.For patients
with a vertical maxillary excess (gummy smile), a large inter-labial gap, a
large incision-stomion distance, a short upper lip, a high gingival smile line,
insufficient or normal freeway space, a long lower facial height, or a steep
mandibular plane, incisor intrusion is recommended as a treatment for deepbite.There are not
many comparative clinical studies in the orthodontic literature comparing the
outcomes of miniscrew-supported incisor intrusion with traditional techniques.In this study,
the effects of incisor intrusion achieved with mini implants and accentuated compensating
curve arch wire will be compared. The patients will be split into two groups (G1 and G2) . Group
G1 will receive mini-implants and the group G2, accentuated compensating curve arch
wire.Standardized
lateral cephalometric radiographs will be obtained before intrusion (T1) and
after intrusion (T2). Horizontal and vertical changes will be measured cephalometrically.
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