| CTRI Number |
CTRI/2026/02/104484 [Registered on: 23/02/2026] Trial Registered Prospectively |
| Last Modified On: |
22/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of dental pain and anxiety in MIH affect teeth during IPC procedure with and without nitrous oxide |
|
Scientific Title of Study
|
Comparative evaluation of management of dental pain and anxiety during Indirect Pulp Capping procedure in MIH affected first permanent molars in pediatric patients aged 7-10 years with and without nitrous oxide oxygen sedation. |
| 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 SHILPA S NAIK |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT |
| Affiliation |
Dr D Y Patil School of Dentistry , Deemed to be University |
| Address |
Dept. of Pediatric and Preventive Dentistry, Dr D Y Patil School of Dentistry ,Deemed to be University , Nerul, Navi Mumbai
Mumbai (Suburban)
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9769600440 |
| Fax |
|
| Email |
shilpa.naik@dypatil.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Rhea Vinit Shah |
| Designation |
Post graduate student |
| Affiliation |
Dr D.Y. Patil University, School of Dentistry, Navi Mumbai. |
| Address |
77/22 Marine drive F-Road, patan jain mandal building no 2, 3rd floor Flat numbe
Mumbai
MAHARASHTRA
400020
India |
| Phone |
9619174826 |
| Fax |
|
| Email |
rheashah64@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rhea Vinit Shah |
| Designation |
Post graduate student |
| Affiliation |
Dr D.Y. Patil University, School of Dentistry, Navi Mumbai. |
| Address |
77/22 Marine drive F-Road, patan jain mandal building no 2, 3rd floor Flat numbe
MAHARASHTRA
400020
India |
| Phone |
9619174826 |
| Fax |
|
| Email |
rheashah64@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dept of Pediatric and Preventive Dentistry |
| Address |
Dr. D.Y. Patil Deemed to be University, School of Dentistry, Sector 7,Highway Road, , Nerul, Navi Mumbai, Thane, Maharashtra. 400706 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Rhea Vinit Shah |
Dr D.Y. Patil University, School of Dentistry, Navi Mumbai. |
Dept of pediatric and preventive dentistry, D Y Patil school of dentistry, deemed to be university, nerul, navi mumbai.
Mumbai
MAHARASHTRA |
09619174826
rheashah64@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutionalresearchand ethicalboard, D. Y.PatilDeemed tobeUniversitySchool ofDentistry,NaviMumbai. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
• First permanent molars affected by MIH requiring Indirect pulp capping procedure as per radiograph
• Children exhibiting Frankel’s behaviour rating 3 or 4
• Children aged between 7-10 years
• Vital pulp with no fistula or abscess, no history of continuous pain and absence of clinical and radiographic signs of pulp necrosis (internal and external root resorption, movement of the tooth, and swelling)
• Based on –
1. Clinical examination
2. Symptoms of the patient
3. Radiographic examination
|
|
| ExclusionCriteria |
| Details |
The presence of any systemic disease
Any potential confounding enamel defects like amelogenesis imperfecta Uncooperative children according to Frankel’s scale (scale 1 and 2)
Children with special health care needs A history of allergic reactions to local anaesthetics or some components of the materials used
Children with upper respiratory tract infections
Any recent middle ear disturbances or infections
Children undergoing treatment with bleomycin sulphate
Untreated cobalamin (vitamin B12) deficiency
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Evaluation of dental pain and anxiety during Indirect Pulp Capping procedure in MIH affected teeth under nitrous oxide-oxygen sedation pre treatment and during caries excavation
2. Evaluation of dental pain and anxiety during Indirect Pulp Capping procedure in MIH affected teeth without nitrous oxide-oxygen sedation
3. Comparative evaluation of dental pain and anxiety during Indirect Pulp Capping procedure in MIH affected teeth with and without nitrous oxide-oxygen sedation.
|
Anxiety will be recorded at baseline and during caries excavation.
Pain will be recorded during caries excavation.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
05/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
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
|
Molar incisor hypomineralization (MIH)–affected first
permanent molars often present with hypersensitivity and exaggerated pain
responses, making routine restorative procedures such as indirect pulp capping
challenging in pediatric patients. Increased dental anxiety and reduced
cooperation in children aged 7–10 years can compromise effective pain control
and treatment outcomes. Nitrous oxide–oxygen inhalation sedation is widely used
in pediatric dentistry for its anxiolytic and analgesic properties, yet evidence
comparing its effectiveness with conventional behavior management during
MIH-related procedures is limited. Therefore, evaluating dental pain and
anxiety during indirect pulp capping with and without nitrous oxide sedation is
clinically relevant for optimizing MIH management in children. A
prospective, comparative, two-arm randomized controlled clinical trial was
conducted on 30 children diagnosed with MIH and requiring indirect pulp therapy
between 7-10 years of age with or without nitrous oxide oxygen sedation. After
initial examination, the children were divided into Group A (Control group- IPC
without nitrous oxide sedation) and Group B (Test group- IPC with nitrous oxide
sedation). Anxiety levels were evaluated by recording the pulse rate and the
Facial Image Scale (FIS) before the procedure and during caries excavation and
Dental pain was evaluated during caries excavation using the Visual Analogue
Scale. |