| CTRI Number |
CTRI/2022/10/046745 [Registered on: 25/10/2022] Trial Registered Prospectively |
| Last Modified On: |
23/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Effect of clipping treatment on downward movement of gums in lower front teeth |
|
Scientific Title of Study
|
EFFECT OF ORTHODONTIC INTERVENTION ON GINGIVAL RECESSION OF SINGLE MALPOSED LOWER ANTERIOR TOOTH-A PROSPECTIVE CLINICAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RIMSHA K P |
| Designation |
PG TRAINEE |
| Affiliation |
SCB dental college and hospital,cuttack ,odisha |
| Address |
Department of orthodontics,
scb dental college and hospital,
Cuttack
ORISSA
753007
India |
| Phone |
09895846831 |
| Fax |
|
| Email |
rimshasubash@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRSURYA KANTA DAS |
| Designation |
HEAD OF DEPAERTMENT |
| Affiliation |
SCB dental college and hospital,cuttack ,odisha |
| Address |
Department of orthodontics,
scb dental college and hospital,cuttack.
Cuttack
ORISSA
753007
India |
| Phone |
9861099237 |
| Fax |
|
| Email |
orthosuryakantadas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RIMSHA K P |
| Designation |
PG TRAINEE |
| Affiliation |
SCB dental college and hospital,cuttack ,odisha |
| Address |
Department of orthodontics,
scb dental college and hospital,
ORISSA
753007
India |
| Phone |
09895846831 |
| Fax |
|
| Email |
rimshasubash@gmail.com |
|
|
Source of Monetary or Material Support
|
| SCB DENTAL COLLEGE AND HOSPITAL,CUTTACK |
|
|
Primary Sponsor
|
| Name |
RIMSHA K P |
| Address |
SCB DENTAL COLLEGE AND HOSPITAL
CUTTACK |
| Type of Sponsor |
Other [RIMSHA K P] |
|
|
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 |
| RIMSHA K P |
SCB DENTAL COLLEGE AND HOSPITAL |
Department of orthodontics,new annexure building,second floor,scb dental college and hospital,
cuttack,odisha
Cuttack
ORISSA |
09895846831
rimshasubash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE,SCB DENTAL COLLEGE AND HOSPITAL,CUTTACK |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
TORQUING SPRING |
TORQUING SPRING IS AN AUXILLARY SPRING USED TO ACHIEVE SINGLE ROOT TORQUE
Total duration -6 months |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
a) Subjects with malpositioned ,single tooth recession(RT-1)on buccal or lingual
surface of mandibular anterior teeth region
b) Subjects with healthy periodontal status of remaining dentition other than the
single tooth recession
c) No history of previous periodontal surgery
|
|
| ExclusionCriteria |
| Details |
a) Patient with systemic disease or under long term medication that alter bone
Metabolism
b) Pregnancy
c) Severe periodontal problems with associated bony defects
d) Severe malocclusions
e) No tobacco related oral habits |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the changes in recession depth and width after orthodontic intervention. |
FIRST DAY,6 MONTHS. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the changes in attached gingiva dimensions (width and thickness) and
probing depth after orthodontic intervention |
FIRST DAY,6 MONTHS |
To evaluate the changes in root inclination and possible bony changes after orthodontic
intervention
|
FIRST DAY,6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
30/10/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Tooth malposition is one of the major contributing factor for gingival recessions.
Teeth which are prominent and out of alignment of the arch may be associated with alveolar dehiscence which can result in recession.
In such situations healing pattern of both gingival grafts and coronally advanced flaps will be affected.
Blood supply can be very scarce in such conditions resulting in graft necrosis.so it is advocated to position the roots within the alveolar envelope reducing the root prominence and allowing creeping of attachment thereby providing a more optimal surgical site |