| CTRI Number |
CTRI/2025/07/092118 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomised study comparing clonidine and adrenaline added to lignocaine for blood pressure stability and pain relief during lower molar tooth extraction. |
|
Scientific Title of Study
|
Comparing clonidine-enhanced lignocaine and adrenaline-enhanced lignocaine for hemodynamic stability and analgesic outcomes in mandibular molar extractions- A randomised 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 AKHOURI PRAKHAR SINHA |
| Designation |
PG 1ST YEAR |
| Affiliation |
KOTHIWAL DENTAL COLLEGE AND RESEARCH CENTRE |
| Address |
Address: Kothiwal Dental College & Research Centre, Haridwar Road, Moradabad-244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
6386046351 |
| Fax |
|
| Email |
drakhouriprakhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AKHOURI PRAKHAR SINHA |
| Designation |
PG 1ST YEAR |
| Affiliation |
KOTHIWAL DENTAL COLLEGE AND RESEARCH CENTRE |
| Address |
Address: Kothiwal Dental College & Research Centre, Haridwar Road, Moradabad-244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
6386046351 |
| Fax |
|
| Email |
drakhouriprakhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AKHOURI PRAKHAR SINHA |
| Designation |
PG 1ST YEAR |
| Affiliation |
KOTHIWAL DENTAL COLLEGE AND RESEARCH CENTRE |
| Address |
Address: Kothiwal Dental College & Research Centre, Haridwar Road, Moradabad-244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
6386046351 |
| Fax |
|
| Email |
drakhouriprakhar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kothiwal Dental College and resaearch centr |
| Address |
KOTHIWAL DENTAL COLLEGE AND RESEARCH CENTRE,Haridwar Road, Mohra Ki Milak, Moradabad, Uttar Pradesh 244001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ankit Kumar |
Kothiwal Dental College and Research Centre |
Department no.2 ground floor Kothiwal Dental College & Research Centre, Haridwar Road, Moradabad-244001
Moradabad
UTTAR PRADESH |
9917114777
ankitkumarleo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IERB KOTHIWAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA PHYSICAL STATUS I AND II |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lignocaine with Adrenaline |
Lignocaine with adrenaline (ADR) is a widely used combination in minor surgical and dental procedures. Lignocaine is a local anesthetic that blocks nerve conduction, providing pain relief. Adrenaline acts as a vasoconstrictor, reducing blood flow at the injection site. This helps prolong the anesthetic effect, minimizes bleeding, and decreases systemic absorption, thereby reducing the risk of lignocaine toxicity. The addition of adrenaline allows for the use of lower doses of lignocaine with improved efficacy. However, caution is needed in areas with end arteries and in patients with cardiovascular conditions due to the potential systemic effects of adrenaline. |
| Intervention |
Lignocaine with clonidine |
Clonidine will be given with lignocaine to cause vasoconstriction without increasing the blood pressure. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 20–60 years
2.ASA (American Society of Anaesthesiologists) physical status I and II
3.No known allergies to lignocaine, clonidine, or adrenaline
4.Presence of dental caries, periapical abscess, or periodontitis requiring extraction
5.Simple, non-complicated extractions
|
|
| ExclusionCriteria |
| Details |
1.Patients on medications that may affect healing (e.g., steroids, anticoagulants)
2.Pregnant or lactating women
3.Patients with bleeding disorders or previous history of extractions
4.Patients with impacted or submerged teeth
5.Patients with a history of smoking, alcohol consumption, or substance abuse.
6.Impacted and unerupted tooth
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time of onset and duration of action - In this, we will assess the time of onset of a drug and how long it takes to start working after administration and assess the duration of action of drug, which refers to the effectiveness of the drug in the body after
administration.
Hemodynamic parameters (Blood Pressure, Mean Arterial Pressure) will be assessed
by Digital Sphygmomanometer
Heart Rate and SpO: will be assessed by pulse oximeter. |
10 min before anaesthesia,10 min after anaesthesia,30 min after surgical procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Post Operative Rescue Analgesics- Time until the initial dose of rescue analgesic following the administration of local anaesthetic.
• Patient-reported pain scores (VAS scale)- The Visual Analog Scale (VAS) is a simple, continuous measurement tool used to assess subjective experiences like pain or emotions. |
Within 24 hours |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
01/09/2025 |
| 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 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 prospective clinical study aims to evaluate the clinical and esthetic outcomes of lip repositioning surgery using diode laser versus conventional scalpel technique in patients with excessive gingival display (gummy smile). Conducted in a single center, the randomized trial will include patients aged 18–45 years diagnosed with excessive gingival display due to hypermobile upper lip or altered passive eruption. Outcomes will be assessed using standardized photographic analysis and patient-reported esthetic satisfaction over a 6-month follow-up. The study will compare post-operative healing, complications, and esthetic results to determine the more effective technique for managing gummy smiles |