| CTRI Number |
CTRI/2023/11/059427 [Registered on: 02/11/2023] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To check the effectiveness of two anesthetic gels in pain control during cleaning |
|
Scientific Title of Study
|
Evaluation of intra pocket anesthetic gels in pain control during scaling and root planing |
| 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 BANDI HAREESH |
| Designation |
POST GRADUATE |
| Affiliation |
NARAYANA DENTAL COLLEGE & HOSPITAL |
| Address |
NARAYANA DENTAL COLLEGE AND HOSPITAL
ROOM NUMBER:5
DEPARTMENT OF PERIODONTOLOGY
CHINTAREDDY PALEM
NELLORE
PIN:524003
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
6309342505 |
| Fax |
|
| Email |
hareeshbandi22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUMANTH GUNUPATI |
| Designation |
PROFESSOR |
| Affiliation |
NARAYANA DENTAL COLLEGE & HOSPITAL |
| Address |
NARAYANA DENTAL COLLEGE AND HOSPITAL
ROOM NUMBER:5
DEPARTMENT OF PERIODONTOLOGY
CHINTAREDDY PALEM
NELLORE
PIN:524003
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9848385378 |
| Fax |
|
| Email |
Sumant29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUMANTH GUNUPATI |
| Designation |
PROFESSOR |
| Affiliation |
NARAYANA DENTAL COLLEGE & HOSPITAL |
| Address |
NARAYANA DENTAL COLLEGE AND HOSPITAL
ROOM NUMBER:5
DEPARTMENT OF PERIODONTOLOGY
CHINTAREDDY PALEM
NELLORE
PIN:524003
ANDHRA PRADESH
524003
India |
| Phone |
9848385378 |
| Fax |
|
| Email |
Sumant29@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR.BANDI HAREESH
NARAYANA DENTAL COLLEGE & HOSPITAL
ROOM NUMBER:5
DEPARTMENT OF PERIODONTOLOGY
CHINTAREDDY PALEM
NELLORE-524003
|
|
|
Primary Sponsor
|
| Name |
DRBANDI HAREESH |
| Address |
NARAYANA DENTAL COLLEGE & HOSPITAL
ROOM NUMBER:5
DEPARTMENT OF PERIODONTOLOGY CHINTAREDDY PALEM NELLORE-524003 |
| 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 BANDI HAREESH |
NARAYANA DENTAL COLLEGE & HOSPITAL |
ROOM NUMBER:5
DEPARTMENT OF PERIODONTOLOGY
CHINTAREDDY PALEM
NELLORE-524003
Nellore
ANDHRA PRADESH |
6309342505
hareeshbandi22@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
SYSTEMICALLY HEALTHY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
2% lignocaine gel application |
After injecting of 2% lignocaine Anaesthetic gel below the gum level, the teeth will be cleaned, pain scores are recorded. |
| Comparator Agent |
Application of 20% Benzocaine gel |
After injecting of 20% Benzocaine Anaesthetic gel below the gum level, the teeth will be cleaned, pain scores are recorded. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient’s age: 30-50 years.
Systemically healthy subjects
Presence of at least 4 sites with probing depth ≥5 mm per quadrant.
Patients who had not undergone any periodontal therapy in the past 6months.
|
|
| ExclusionCriteria |
| Details |
Patients requiring prophylactic antibiotics before periodontal probing.
Patients Suffering from any mental disorders or with any chronic pain problems.
Patients suffering with coagulation/bleeding disorders or on anticoagulants,
Pregnant or lactating women.
Patients reporting hypersensitivity to lignocaine,Benzocaine.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual analogue scale (VAS)
Verbal Rating Scale(VRS)
|
BASELINE.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Probing pocket depth(PPD).
Modified sulcular bleeding index (mSBI).
Gingival index(GI)
|
BASELINE,
ONE 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
|
N/A |
|
Date of First Enrollment (India)
|
06/12/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
AIM:The aim of the study is to evaluate and Compare the effectiveness of Lignocaine and Benzocaine anesthetic gels as intra pocket anesthesia in the treatment of scaling and root planing.
All the participants were explained about the aim,nature,and design of the study along with written informed consent for their participation before the commencement of the study.
The study is planned as randomized clinical trial conducted in healthy individuals with periodontitis.The study duration is 9-12 months in which all clinical parameters- Probing pocket depth(PPD),Modified sulcular bleeding index (mSBI),Gingival index(GI) and Visual analogue scale(VAS),Verbal rating scale (VRS) will be recorded at baseline.
All the patients included in the study will be evaluated before the treatment procedure and patients with periodontitis selected.
Two sites left and right halves of the mandibular/maxillary arch will be selected and assigned as test and control group by flipping a coin.
Test group:2% Lignocaine intrapocket anesthetic gel application
Control group:20% Benzocaine intrapocket anesthetic gel application
Procedure:A split mouth design will be followed,where the bilateral quadrants with periodontal pockets will be chosen, 60 sites from 30 patients will be selected and grouped as test and control site.
The test site will receive topical 2% Lignocaine gel subgingivally and control site will receive 20%Benzocaine gel subgingivally in the pocket using a blunt applicator followed by the two sites (test/control) will be subjected to scaling and root planing. After completion, the patient will be asked to fill the pain assessment scales Visual analogue scale (VAS) and Verbal rating scale (VRS) for root planing in the respective quadrant/sextant.
All the patients will be recalled again after 1 month for re-evaluation of clinical parameters-Probing pocket depth(PPD),Modified sulcular bleeding index (mSBI),Gingival index(GI) in both test and control groups.
|