| CTRI Number |
CTRI/2020/06/025724 [Registered on: 09/06/2020] Trial Registered Prospectively |
| Last Modified On: |
04/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Evaluation of gain in soft tissue and hard tissue levels in patients with Infrabony Periodontal Pockets Treated by minimally invasive surgical technique with Conventional flap method |
|
Scientific Title of Study
|
Comparative Evaluation of Gain in Clinical Attachment and Alveolar Bone Levels in Patients with Infrabony Pockets Treated by Minimally Invasive Surgical Technique and Modified Widman Flap- A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shaheda Tabassum |
| Designation |
Pg Student |
| Affiliation |
S.C.B Dental College and Hospital |
| Address |
Department of Periodontics,3rd floor,S.C.B dental college and hospital,Cuttack.
Cuttack
ORISSA
753007
India |
| Phone |
8010650584 |
| Fax |
|
| Email |
shahi247nk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subash Chandra Raj |
| Designation |
Incharge and Associate Professor |
| Affiliation |
S.C.B Dental College and Hospital |
| Address |
Department of Periodontics,SCB dental college and hospital,Cuttack.
Cuttack
ORISSA
753007
India |
| Phone |
9437008298 |
| Fax |
|
| Email |
drsubash007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shaheda Tabassum |
| Designation |
Pg Student |
| Affiliation |
S.C.B Dental College and Hospital |
| Address |
Department of Periodontics,3rd floor,SCB dental college and hospital,Cuttack.
Cuttack
ORISSA
753007
India |
| Phone |
8010650584 |
| Fax |
|
| Email |
shahi247nk@gmail.com |
|
|
Source of Monetary or Material Support
|
| SCB dental college and hospital,Cuttack,Odisha-753007 |
|
|
Primary Sponsor
|
| Name |
SCB dental college and hospitalCuttack |
| Address |
SCB dental college and hospital,Cuttack,Odisha-753007 |
| Type of Sponsor |
Government 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 |
| Shaheda Tabassum |
SCB dental college and hospital,Cuttack. |
Department of Periodontics,3rd floor,SCB dental college and hospital,Cuttack 753007.
Cuttack
ORISSA |
8010650584
shahi247nk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(IEC) SCB DENTAL COLLEGE AND HOSPITAL, CUTTACK, ODISHA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Modified Widman flap surgery |
By using conventional periodontal surgical instruments |
| Intervention |
Modified Widman Flap Surgery using minimally invasive surgical technique. |
Microsurgery using dental Loupes and microsurgical instruments.
Total duration of study- 1 year
Follow up for 6 months (1st month,3rd month and 6th month) |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1)25 years -55 years. At least one periodontal infrabony pocket (detected radiographically) with Probing depth (PD) ≥5 mm,
2)Adequate width of attached gingiva,
3)Plaque index < 30 %
|
|
| ExclusionCriteria |
| Details |
1)Non compliant patients.
2)Previous periodontal surgery within the last 6 months in area of interest.
3)Systemic conditions which are generally considered to be a contraindication to periodontal surgery .
4)Pregnant or lactating females
5)Current or former smokers.
6)Hopeless tooth.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical Attachment Level
|
1 month ,3 months,6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Alveolar bone fill |
1 month ,3 months,6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/06/2020 |
| 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)?
|
|
Brief Summary
|
In this randomized clinical controlled study,chronic periodontitis patients with infrabony pockets will be selected.They will be treated with minimally invasive surgical technique using dental loupes & microsurgical instruments and sutures and Modified Widman flap surgery . Here we will do comparative evaluation of clinical attachment level and alveolar bone level at baseline ,1st month ,3rd month and 6th month after surgery. |