| CTRI Number |
CTRI/2018/05/013562 [Registered on: 01/05/2018] Trial Registered Prospectively |
| Last Modified On: |
27/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative analysis to study the effect of single flap approach over double flap approach |
|
Scientific Title of Study
|
Comparative Evaluation Of Single Versus Double Flap Approach In Periodontal Treatment Outcome- A Split Mouth, Randomized Controlled 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 |
Dr Mathala Venkata lakshmi |
| Designation |
Post graduate student |
| Affiliation |
Vishnu Dental College |
| Address |
Department of periodontics,
Block no. 2,
Room no. 7,
Vishnu dental college,
Vishnupur,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7093419440 |
| Fax |
|
| Email |
venkatalakshmimathala.1989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KSVRamesh |
| Designation |
Associate professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of periodontics,
Block no. 2,
Room no. 7,
Vishnu dental college,
Vishnupur,
Bhimavaram
Andhra Pradesh.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8886157669 |
| Fax |
|
| Email |
ksv006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr KSVRamesh |
| Designation |
Associate professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of periodontics,
Block no. 2,
Room no. 7,
Vishnu dental college,
Vishnupur,
Bhimavaram
Andhra Pradesh.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8886157669 |
| Fax |
|
| Email |
ksv006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Periodontics And Implantology, Room no-7, Block no-2, Vishnu Dental College, Bhimavaram |
|
|
Primary Sponsor
|
| Name |
M Venkata lakshmi |
| Address |
Department of periodontics,
Vishnu dental college,
Vishnupur,
Bhimavaram - 534 202,
West Godavari District,
Andhra Pradesh.
|
| 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 |
| M Venkata lakshmi |
Vishnu Dental College |
Department of periodontics,
Block –II,
Room number-7,
Vishnupur,
Bhimavaram
West Godavari
ANDHRA PRADESH |
7093419440
venkatalakshmimathala.1989@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic periodontitis and Aggressive periodontitis , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Double flap approach |
Double flap approach consists of elevation of the mucoperiosteal flap on both sides to allow surgical access and visibility from both buccal and oral aspects |
| Intervention |
Single flap approach |
The single-flap approach (SFA) consists of
the elevation of a limited mucoperiosteal flap to allow surgical
access from either the buccal or oral aspect
only, leaving the interproximal supracrestal gingival tissues
intact. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age range of 18-60years
2.Patients with chronic or aggressive periodontitis.
3.Minimum of three teeth involving with ≥ 5mm probing pocket depth
4.Intraosseous defects
5.Teeth with grade II furcation involvement
|
|
| ExclusionCriteria |
| Details |
1.Teeth with grade III mobility
2.Teeth with grade III furcation involvement
3.Patients with uncontrolled systemic diseases.
4.Use of medications affecting periodontal status.
5.Pregnant or lactating.
6.Teeth with significant active caries or other dental problems.
7.Patients with extensive periodontal therapy in the previous 6 months.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Periodontal outcome |
Periodontal outcome will be reevaluated at 3 & 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient comfort, Early wound healing, pain assessment |
Patient comfort, Early wound healing, pain assessment will be reevaluated at 10 days after surgery |
| Radiographic bone level |
Radiographic bone level will be reevaluated at 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
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2018 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a randomized controlled clinical trail comparing the single and double flap approaches in 20 subjects and this will be conducted in one Centre in India and the primary outcome measure is periodontal outcome and it will be reevaluated at 3 and 6 months. secondary outcome -Radiographic bone level will be reevaluated at 6 months. patient comfort, Early wound healing and pain assessment will be reevaluated at 10 days after surgery |