| CTRI Number |
CTRI/2025/12/098876 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
This study will compare laughing gas sedation and regular numbing injections to determine which will provide better patient comfort during gum treatment in adults. |
|
Scientific Title of Study
|
Comparative evaluation of patient experience with Nitrous Oxide Sedation and Local Anesthesia in Non-Surgical Periodontal Therapy. |
| 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 Ruchi Ramanujan |
| Designation |
Post graduate |
| Affiliation |
A B Shetty Memorial Institute of Dental Sciences |
| Address |
4th floor, Department of Periodontology, A B Shetty Memorial Institute of Dental Sciences, Medical Sciences Complex Deralakatte, Mangaluru, 575018, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9591543887 |
| Fax |
|
| Email |
drruchiramanujan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Bhandary |
| Designation |
Professor |
| Affiliation |
A B Shetty Memorial Institute of Dental Sciences |
| Address |
4th floor, Department of Periodontology, A B Shetty Memorial Institute of Dental Sciences, Medical Sciences Complex Deralakatte, Mangaluru, 575018, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845583085 |
| Fax |
|
| Email |
drrahulbhandary@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchi Ramanujan |
| Designation |
Post graduate |
| Affiliation |
A B Shetty Memorial Institute of Dental Sciences |
| Address |
4th floor, Department of Periodontology, A B Shetty Memorial Institute of Dental Sciences, Medical Sciences Complex Deralakatte, Mangaluru, 575018, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9591543887 |
| Fax |
|
| Email |
drruchiramanujan@gmail.com |
|
|
Source of Monetary or Material Support
|
| A B Shetty Memorial Institute of Dental Sciences, Medical Sciences Complex Deralakatte, Mangaluru, 575018, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Ruchi Ramanujan |
| Address |
4th floor, Department of Periodontology, A B Shetty Memorial Institute of Dental Sciences, Medical Sciences Complex Deralakatte, Mangaluru, 575018, Karnataka, India |
| 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 Ruchi Ramanujan |
A B Shetty Memorial Institute of Dental Sciences |
4th floor, Department of Periodontology, A B Shetty Memorial Institute of Dental Sciences, Medical Sciences Complex Deralakatte, Mangaluru, 575018, Karnataka, India
Dakshina Kannada
KARNATAKA |
9591543887
drruchiramanujan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| A B Shetty Memorial Institute of Dental Sciences Institutional Ethical Committee |
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 |
Local anesthesia |
Local anesthetic infiltration using 2% lidocaine with adrenaline (1:80,000) will be administered without nitrous oxide, and will provide an approximate duration of action of 2 hours during non-surgical periodontal therapy on the contralateral randomized quadrant. |
| Intervention |
Nitrous oxide–oxygen inhalation sedation with local anesthesia |
Nitrous oxide–oxygen conscious sedation will be delivered via a nasal hood at titrated concentrations, followed by infiltration of 2% lidocaine with adrenaline (1:80,000). The intervention will be administered for approximately 45 minutes during non-surgical periodontal therapy (scaling and root planing) on the randomized quadrant, to assess patient comfort under sedation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy adults (18-65 years) of either sex with moderate to severe periodontitis.
2. Patients with no prior dental experience with a need for scaling and root planing in at least two quadrants.
3. Patients with an ability to understand and sign informed consent.
4. No contraindications for nitrous oxide inhalation sedation or local anesthesia.
5. Patients satisfied with American Society of Anesthesiologists (ASA) grade I and II. |
|
| ExclusionCriteria |
| Details |
1. Severe systemic health issues (ASA Grade III or higher).
2. History of allergic reactions to local anesthesia or nitrous oxide
3. Pregnancy or lactation states
4. Severe dental anxiety that may require alternate sedation techniques
5. Patients who had deep dental cleaning in the past
6. Current middle ear surgery
7. Patients on bleomycin sulphate therapy
8. Patient who were mouth breathers/ had claustrophobia/ unwilling to accept nasal hood
9.Patients who had upper respiratory tract infections (common cold, accute or chronic sinus, bronchitis cough, tuberculosis, emphysema) or any other serious respiratory ailment
10. Not willing for Nitrous Oxide Inhalation Sedation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Patient-reported anxiety score associated with non-surgical periodontal therapy under nitrous oxide–oxygen inhalation sedation and local anesthesia, measured using a validated anxiety scale (SAI and vital signs).
2. Patient-reported intra-operative pain score during non-surgical periodontal therapy with nitrous oxide–oxygen inhalation sedation and local anesthesia, measured using a validated pain scale (VAS).
3. Post-operative patient satisfaction during non-surgical periodontal therapy performed with nitrous oxide–oxygen inhalation sedation and local anesthesia, assessed using a patient satisfaction questionnaire. |
1. Anxiety levels: Pre-operative, intra-operative, and immediately post-operative for both treatment conditions.
2. Pain levels: Immediately after local anesthetic administration and 15 minutes after onset of instrumentation during each treatment session.
3. Patient Satisfaction Levels: Immediately after completion of each treatment session , within the 2-week treatment period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(i) duration of procedure recorded using a stopwatch from onset of instrumentation to completion under each anesthetic protocol, and
(ii) clinical periodontal parameters (PD, CAL, BOP) assessed at baseline and at 2-week follow-up in both quadrants. |
1. Duration of procedure: Measured intra-operatively during each treatment session
2. Clinical parameters: Baseline and 2-week post-treatment |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
26/12/2025 |
| 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="6"
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 aims to evaluate and compare nitrous oxide oxygen inhalation sedation combined with local anesthesia and local anesthesia alone during non surgical periodontal therapy. The study will assess anxiety levels, pain perception, treatment comfort, and patient satisfaction. By identifying whether nitrous oxide offers additional benefits over local anesthesia alone, the study may help improve patient experience, compliance, and overall treatment outcomes in periodontal care. The findings may also support the use of nitrous oxide inhalation sedation as a routine clinical option in periodontal procedures. |