| CTRI Number |
CTRI/2023/09/058078 [Registered on: 27/09/2023] Trial Registered Prospectively |
| Last Modified On: |
25/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of healing, recurrence of gum blackening and feeling of pain following treatment of black gums with surgical hand held instrument and rotary instrument: A bilateral mouth comparison study of 2 different technique. |
|
Scientific Title of Study
|
Comparative evaluation of healing, recurrence of pigmentation and pain perception following depigmentation with scalpel and ceramic soft tissue trimming bur: A split mouth randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kinjal Dabhi |
| Designation |
PG Student |
| Affiliation |
Government Dental College and Hospital, Jamnagar |
| Address |
Government Dental College and Hospital Main Road Rameshwar Nagar
Government Dental College and Hospital Main Road Rameshwar Nagar
Jamnagar
GUJARAT
361008
India |
| Phone |
09173660283 |
| Fax |
|
| Email |
khdabhi11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayana Patel |
| Designation |
PG Guide |
| Affiliation |
Government Dental College and Hospital, Jamnagar |
| Address |
101 Gulab Avenue Near Park Colony Jamnagar 361008
Government Dental College and Hospital Main Road Rameshwar Nagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9825191911 |
| Fax |
|
| Email |
drnayanagpatel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kinjal Dabhi |
| Designation |
PG Student |
| Affiliation |
Government Dental College and Hospital, Jamnagar |
| Address |
Government Dental College and Hospital Main Road Rameshwar Nagar
Government Dental College and Hospital Main Road Rameshwar Nagar
Jamnagar
GUJARAT
361008
India |
| Phone |
09173660283 |
| Fax |
|
| Email |
khdabhi11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital, Jamnagar |
|
|
Primary Sponsor
|
| Name |
Dr Kinjal Dabhi |
| Address |
Government Dental College and Hospital, Jamnagar. Navagam Ghed 361008 |
| 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 |
| Dr Kinjal Dabhi |
Government Dental College and Hospital, Jamnagar |
Department of Periodontology, Room No. 112, GDCHJ, Navagam.
Jamnagar
GUJARAT |
09173660283
khdabhi11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee M.P. Shah Medical College and Guru Gobindsingh Hospital, Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gingival Depigmentation with ceramic soft tissue trimming bur |
Gingival depigmentation will be done with ceramic soft tissue trimming bur using airoter. It is a rotary tool used to cut and reshape the soft tissue. It is attached with airoter handpeice. For depigmentation procedure, after giving local anesthesia rotating bur was moved over the pigmented gingival tissue. Intermittent irrigation will be done with saline. After complete removal of pigmented epithelium periodontal pack will be given. Analgesics will be prescribed. Total procedure time is upto 1 hour. Follow-up will be done after 1 week, 1-month and 3 months of procedure. |
| Comparator Agent |
Gingival Depigmentation with scalpel |
Gingival Depigmentation will be done using surgical scalpel. After giving local anesthesia pigmented epithelium over gingiva will be removed with surgical scalpel using B.P. Blade no. 15 and blade handle in scrapping motion. After complete removal of pigmented epithelium irrigation will be done with saline and periodontal pack will be given. Total procedure time is upto 1 hour. Follow-up will be done after 1 week, 1-month and 3 months of procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Person with bilateral gingival hyperpigmentation with Dummet Oral Pigmentation Index: Score 2, 3 Gingival Pigmentation Index by Kumar S: Score 2, 3 |
|
| ExclusionCriteria |
| Details |
Patient with acute pain or swelling in oral cavity, Pregnant or lactating women, Smokers |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in pigmentation index score and improved aesthetic |
1 Week, 1 Month, 3 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved aesthetic |
1 Week, 1 Month,3 Month |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/10/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is done to evaluate healing, recurrence of pigmentation and pain perception following depigmentation with scalpel and ceramic soft tissue trimming bur. 30 such cases will be included in this study. Samples will be divided into 2 groups (1)Control group- Depigmentation with scalpel (2)Test group- Depigmentation with ceramic soft tissue trimming bur. Cluinical assessment will be done at baseline, 1 week, 1 Month and 3 Month for pigmentation. Healing will be assessed after 1 week. Visual analog scale will be taken postoperatively. |