| CTRI Number |
CTRI/2021/10/037335 [Registered on: 14/10/2021] Trial Registered Prospectively |
| Last Modified On: |
13/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
ROLE OF PRF IN DARKGUMS TREATING WITH TWO SURGICAL METHODS. |
|
Scientific Title of Study
|
CLINICAL AND HISTOLOGICAL COMPARISON OF PLATELET RICH FIBRIN IN THE TREATMENT OF
GINGIVAL HYPERPIGMENTATION WITH
SCALPEL AND SOFT TISSUE TRIMMING BUR. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr G Vikram Reddy |
| Designation |
Professor |
| Affiliation |
Kamineni Institute of Dental Sciences |
| Address |
Room No-6, Department of Periodontics
Kamineni Institute Of Dental Sciences, Narketpally, Telangana.
Room No-6, Department of Periodontics
Kamineni Institute Of Dental Sciences, Narketpally, Telangana.
Nalgonda
TELANGANA
508254
India |
| Phone |
9849990058 |
| Fax |
|
| Email |
vikramreddydr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Peddireddy Tejaswi |
| Designation |
Post Graduate |
| Affiliation |
Kamineni Institute of Dental Sciences |
| Address |
Room No-6, Department of Periodontics
Kamineni Institute Of Dental Sciences, Narketpally, Telangana.
Room No-6, Department of Periodontics
Kamineni Institute Of Dental Sciences, Narketpally, Telangana.
Nalgonda
TELANGANA
508213
India |
| Phone |
9491768820 |
| Fax |
|
| Email |
peddireddy.tejaswi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Peddireddy Tejaswi |
| Designation |
Post Graduate |
| Affiliation |
Kamineni Institute of Dental Sciences |
| Address |
Room No-6, Department of Periodontics
Kamineni Institute Of Dental Sciences, Narketpally, Telangana.
Room No-6, Department of Periodontics
Kamineni Institute Of Dental Sciences, Narketpally, Telangana.
Nalgonda
TELANGANA
508213
India |
| Phone |
9491768820 |
| Fax |
|
| Email |
peddireddy.tejaswi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peddireddy Tejaswi
Room No-6, Department of Periodontics
Kamineni Institute Of Dental Sciences, Narketpally, Telangana. |
|
|
Primary Sponsor
|
| Name |
PEDDIREDDY TEJASWI |
| Address |
Room no-6, department of periodontics
KAMINENI INSTITUTE OF DENTAL SCIENCES NARKETPALLY TELANGANA |
| 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 |
| Peddireddy Tejaswi |
Kamineni Institute of Dental Sciences |
Room No-6, Department of Periodontics
Kamineni Institute Of Dental Sciences, Narketpally, Telangana.
Nalgonda
TELANGANA |
09491768820
peddireddy.tejaswi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee,kamineni institute of dental sciences |
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 |
| Comparator Agent |
Depigmentation wit soft tissue trimming bur |
PRF is prepared according to choukrouns protocol and compare healing after gingival depigmentation using scalpel and soft tissue trimming bur |
| Intervention |
GINGIVAL DEPIGMENTATION with scalpel |
gingival depigmentation with scalpel and soft tissue trimming bur |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 15-45 years.
GENDER: MALE AND FEMALE
Patients with gingival hyperpigmentation.
Systemically healthy patients. |
|
| ExclusionCriteria |
| Details |
SMOKERS
PREGNANT AND LACTATING WOMENS
SYSTEMICALLY COMPROMISED PATIENTS
PATIENTS ON ANTIBIOTIC MEDICATIONS |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Dummett oral pigmentation Index
Epithelization test |
Base line, fifth day, seventh day, 1 month,3months and months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Visual analog scale [VAS].
Healing Index [HI] according to Landry et al. |
AT 7TH DAY AND AFTER ONE MONTH |
|
|
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)
|
28/10/2021 |
| 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
|
SOURCE OF DATA: All the patients will be selected from outpatient Department of Periodontics, Kamineni Institute of Dental Sciences, Narketpally, Nalgonda.
INCLUSION CRITERIA:
1. Age group between 15-45 years. 2. Patients with gingival hyperpigmentation. 3. Systemically healthy patients.
EXCLUSION CRITERIA: 1. Systemically compromised patients and those on medications that may interfere with wound healing. 2. Pregnant women and lactating mother. 3. Patients with a history of severe acute or chronic systemic disease affecting periodontal condition. 4. Patients taking antibiotics for any chronic inflammatory condition 5. Smokers and 6. Endocrine diseases such as addison’s disease, acromegaly and Albright`s syndrome7.
SAMPLE SIZE :The study consists of 40 sites which will assigned into four groups. Group I: 10 Sites- scalpel+ PRF. Group II: 10 sites- scalpel. Group III:10 sites- soft tissue trimming bur + PRF. Group IV: 10 sites- soft tissue trimming bur. The parameters that will be assessed are: At baseline: 1. Dummett oral pigmentation Index 2. Epithelization test. After one week: 1. Visual analog scale [VAS]. 2. Healing Index [HI] according to Landry et al. 3. Dummet oral pigmentation Index. 4. Epithelization test. After 30th day/ 3rd month: 1. Dummet oral pigmentation Index. Aim :- to evaluate the effectiveness of PRF in wound healing to compare and evaluate the effect of PRF placed after the treatment of gingival hyperpigmentation with scalpel and soft tissue trimming bur |