| CTRI Number |
CTRI/2025/09/094809 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
13/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Buffered Lignocaine and Buffered Articaine for Pain Control in Mandibular Gum Surgery: A Study in Adults |
|
Scientific Title of Study
|
Buffered 2 percent Lignocaine Vs Buffered 4 percent articaine in Mandibular Flap Surgery A Double Blind Split Mouth 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 Gangolu Meghana |
| Designation |
Assistant Professor |
| Affiliation |
sibar institute of dental sciences |
| Address |
Room no.8,2nd floor, Department of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509
Guntur
ANDHRA PRADESH
India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8143458843 |
| Fax |
|
| Email |
drmeghanagperio@sids.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gangolu Meghana |
| Designation |
Assistant Professor |
| Affiliation |
sibar institute of dental sciences |
| Address |
Room no.8,2nd floor, Department of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509
Guntur
ANDHRA PRADESH
India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8143458843 |
| Fax |
|
| Email |
drmeghanagperio@sids.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vintha jaswitha |
| Designation |
Assistant Professor |
| Affiliation |
sibar institute of dental sciences |
| Address |
Room no.8,2nd floor, Department of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509
Guntur
ANDHRA PRADESH
India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8790994930 |
| Fax |
|
| Email |
drjaswithavperio@sids.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Gangolu Meghana |
| Address |
Room no.8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences,Takkellapadu,522509 |
| 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 Gangolu Meghana |
Sibar institute of dental sciences |
Room no.8,2nd floor, Department of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509
Guntur
ANDHRA PRADESH
India
Guntur
ANDHRA PRADESH |
8143458843
drmeghanagperio@sids.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sibar Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Buffered Articaine |
4% Articaine with 1:100,000 epinephrine was similarly buffered with sodium bicarbonate in a 10:1 ratio in a span of 30 seconds. The assigned anaesthetic buffered Articaine was administered via inferior alveolar nerve block by syringe.
Preparation of the Sodium Bicarbonate buffered Lignocaine and Articaine solution will be done by adding 0.6 mL of 8.4% sodium bicarbonate to 3 mL of LA.
|
| Intervention |
Buffered Lignocaine |
The assigned anaesthetic buffered lignocaine was administered via inferior alveolar nerve block by syringe in a span of 30 seconds.
Preparation of the Sodium Bicarbonate buffered 2% Lignocaine with 1:100,000 epinephrine was buffered with 8.4% sodium bicarbonate in a 10:1 ratio immediately before injection. Lignocaine and Articaine solution will be done by adding 0.6 mL of 8.4% sodium bicarbonate to 3 mL of LA.
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients requiring bilateral mandibular periodontal surgery
2 Age between 30- 60 years.
3 No allergy to local anesthetics or sodium bicarbonate.
4 Willingness to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
•Pregnant or lactating women
•Patients with systemic conditions affecting wound healing (e.g., diabetes)
•History of hypersensitivity to local anesthetics or epinephrine
•Active infection at the surgical site |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Onset Time
2.Duration of Anesthesia
3.VAS Pain Score
|
1.Time from injection to onset of numbness (in seconds)
2.Time from onset to return of normal sensation (in how many seconds)
3.45 minutes
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reinjection Needed
2 Any Adverse Effects
|
1. within 45 minutes
2. after 1 day |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
26/09/2025 |
| 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="0"
Months="0"
Days="13" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 double-blind, split-mouth randomized controlled trial is designed to compare the clinical efficacy of buffered 2 percent lignocaine and buffered 4 percent articaine in patients undergoing bilateral mandibular periodontal flap surgery. To enhance onset and comfort. A total of 16 patients ie 32 surgical sites will be enrolled. Each patient will receive both anaesthetics on contralateral sides in two appointments. The buffered solutions are prepared with sodium bicarbonate Clinical outcomes assessed include onset time, duration of anaesthesia, intraoperative pain VAS, need for reinjection, and adverse effects. Randomization and blinding of operator and patient will minimize bias, and all surgeries will be performed by the same periodontist. Statistical analysis will involve paired t-tests for continuous variables and chi-square tests for categorical data, with significance set at p < 0.05. The study aims to determine whether buffered articaine provides superior onset, duration, and patient comfort compared to buffered lignocaine, thereby guiding clinicians in optimal anaesthetic choice for mandibular periodontal surgeries. |