| CTRI Number |
CTRI/2022/09/045583 [Registered on: 16/09/2022] Trial Registered Prospectively |
| Last Modified On: |
20/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EVALUATION OF BONE AND GUM RELATED CHANGES FOLLOWING UPPER INCISOR INTRUSION WITH ONE OR TWO FORWARDLY PLACED METAL SCREWS |
|
Scientific Title of Study
|
EVALUATION OF DENTOALVEOLAR AND GINGIVAL CHANGES
FOLLOWING MAXILLARY INCISOR INTRUSION WITH ONE
VERSUS TWO ANTERIOR MINISCREWS – A RANDOMIZED
CLINICAL TRIAL
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MANIKANDAN M |
| Designation |
PG TRAINEE |
| Affiliation |
SCB Dental College and Hospital, Cuttack |
| Address |
Dept of Orthodontics Dentofacial Orthopedics,SCB Dental College,Manglabag,Cuttack,Odisha, 753007
Cuttack
ORISSA
753007
India |
| Phone |
08825753075 |
| Fax |
|
| Email |
manibds1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SURYA KANTA DAS |
| Designation |
HOD & PROF |
| Affiliation |
SCB Dental College and Hospital, Cuttack |
| Address |
Dept of Orthodontics Dentofacial Orthopedics,SCB Dental College,Manglabag,Cuttack,Odisha, 753007
Cuttack
ORISSA
753007
India |
| Phone |
9861099237 |
| Fax |
|
| Email |
orthosuryakantadas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MANIKANDAN M |
| Designation |
PG TRAINEE |
| Affiliation |
SCB Dental College and Hospital, Cuttack |
| Address |
Dept of Orthodontics Dentofacial Orthopedics,SCB Dental College,Manglabag,Cuttack,Odisha, 753007
Cuttack
ORISSA
753007
India |
| Phone |
08825753075 |
| Fax |
|
| Email |
manibds1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| S.C.B DENTAL COLLEGE&HOSPITA,CUTTACK |
|
|
Primary Sponsor
|
| Name |
MANIKANDAN M |
| Address |
DEPT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS,S.C.B DENTAL COLLEGE, CUTTACK |
| Type of Sponsor |
Other [] |
|
|
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 |
| MANIKANDAN M |
SCB DENTAL COLLEGE&HOSPITAL, CUTTACK |
Dept of Orthodontics andDentofacial Orthopedics,SECOND FLOOR,NEW ANNEXURE BUILDING
Cuttack
ORISSA |
8825753075
manibds1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION ETHICS COMMITTEE,SCB DCH,CUTTACK |
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 |
| Intervention |
SUBJECTS WITH 2 TADS |
group 2 subjects will receive bilateral miniscrews (between lateral incisor and canine)
to facilitate application of intrusive force to the maxillary anterior teeth.
|
| Comparator Agent |
SUBJECTS WITH SINGLE TAD |
one midline screw will be inserted in the group 1 subjects
to facilitate application of intrusive force to the maxillary anterior teeth.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Non-growing subjects
2. Subjects with incisor inclination smaller than 110° (U1-PP)
3. Gummy smile of more than 3 mm
4. Deep bite more than 4mm
5. Pseudo-deep bite cases (Extruded upper incisors)
6. Skeletal class I and class II
7. Subjects with maxillary anterior dentoalveolar height (U1NF) more than 32.6mm for
males and 29.2mm for females. |
|
| ExclusionCriteria |
| Details |
1. Subjects with previous history of orthodontic treatment, history of trauma or
endodontic treatment of the maxillary incisors.
2. Pregnancy
3. Subjects with systemic disease or under long term medication.
4. Subjects exhibiting poor oral hygiene and motivation.
5. Vertical maxillary excess requiring orthognathic surgery.
6. High collum angle (>12°)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the amount of intrusion per unit time (rate of intrusion).
|
1st day, 6th month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the upper incisor root resorption.
|
1st day, 6th month |
To evaluate the changes in inclination of incisors.
|
1st day, 6th month |
To evaluate the changes in periodontal tissue status.
|
1st day,1.5 months,3 months,4.5 months,6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
18/09/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Structural integrity, functional stability and esthetic harmony are the three important aspects of Jackson’s triad. Correction of the deep bite is often a main objective of the orthodontic treatment because of its potentially detrimental effects on periodontal health, temporomandibular joint function, as well as esthetics. When surgical treatment is not an option because of the patient’s refusal to undergo surgery, or because no maxillary vertical excess is present, the use of miniscrews is a treatment option that offers an effective method for attaining maxillary incisor intrusion and correcting the gummy smile. Apart from establishing a functional occlusion and improving dental and facial aesthetics, one of the major objectives of orthodontic therapy is enhancement and maintenance of periodontal health. Therefore it is of utmost importance to evaluate any periodontal changes after orthodontic intervention. Currently, cone-beam computed tomography (CBCT), as employed in rapid maxillary expansion and molar intrusion, is the leading tool for in vivo dental imaging in the field of root resorption research. The purpose of this study is to evaluate the dentoalveolar and gingival changes associated with intrusion of maxillary incisors with the help of single midline miniscrew as compared to two bilateral miniscrews (between lateral incisor and canine) as anchorage unit. |