| CTRI Number |
CTRI/2018/04/013469 [Registered on: 25/04/2018] Trial Registered Prospectively |
| Last Modified On: |
14/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the postsurgical wound healing using different suture materials during gum surgeries |
|
Scientific Title of Study
|
Comparative evaluation of different suture materials during Periodontal Flap surgeries: A 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 |
Korukonda Radha Rani |
| Designation |
Post Graduate student |
| Affiliation |
Vishnu Dental College |
| Address |
Room no.7
Department of Periodontics & Implantology,
Block II
Vishnu dental college,
Vishnupur,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9676461161 |
| Fax |
|
| Email |
radharani.k1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gautami S Penmetsa |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Room no.7
Department of Periodontics & Implantology,
Block II
Vishnu dental college,
Vishnupur,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9951011618 |
| Fax |
|
| Email |
gautamipenmetsa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gautami S Penmetsa |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Room no.7
Department of Periodontics & Implantology,
Block II
Vishnu dental college,
Vishnupur,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9951011618 |
| Fax |
|
| Email |
gautamipenmetsa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College,
Bhimavaram-534202 |
|
|
Primary Sponsor
|
| Name |
Korukonda Radha Rani |
| Address |
Department of Periodontics and Implantology,
Block-II,
Room Number-7,
Vishnu dental college,
Bhimavaram- 534202,
West Godavari,
Andhra Pradesh,
India.
|
| 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 |
| Korukonda Radha Rani |
Vishnu Dental College |
Department of Periodontics and Implantology,
Block-II,
Room Number-7,
Bhimavaram- 534202
West Godavari
ANDHRA PRADESH |
9676461161
radharani.k1993@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 & Aggressive Periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Black silk suture (Mersilk)
Polyglactin 910 (Monocryl)
expanded polytetrafluorethylene suture (Goretex)
|
monofilamentous (ePTFE suture, Monocryl polyglactin 910 suture) sutures after periodontal flap surgery and recalled after 7 days for suture removal. Suture material used is 4-0 size,75cm length,19 gauge needle,20-26 mm length needle with reverse cutting edge |
| Comparator Agent |
Black silk suture(Mersilk) |
Multifilamentous (Black silk) suture placed after periodontal flap surgery and recalled for suture removal after 7 days. Suture material used is 4-0 size,75cm length,19 gauge needle,20-26 needle length with reverse cutting edge |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 20-65 years
2. Presence of atleast 2 or more teeth on each side of mouth with probing depth and clinical attachment level greater than 5mm.
3. Systemically healthy patients with no contraindications for periodontal surgery.
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy or lactating women
2. Uncontrolled systemic diseases.
3. Consistent poor oral hygiene
4.Significant active caries
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Periodontal pocket elimination, Clinical attachment level gain |
Baseline, 1st month and 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Suture handling characteristics
Early wound healing, Pain scale and tissue reactions.
|
baseline, 7th day, 15th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is randomized controlled clinical trial to compare and clinically evaluate black silk (MERSILK),Polyglactin 910 (MONOCRYL), ePTFE (GORETEX) sutures during periodontal flap surgeries. The primary outcome is periodontal outcome which include reduction in probing pocket depth & gain in clinical attachment level recorded at 3 and 6 months. Secondary variables are proper handling of suture materials, early wound healing, assessment of pain, tissue reactivity at 7th day and 15th day. |