| CTRI Number |
CTRI/2026/04/108161 [Registered on: 10/04/2026] Trial Registered Prospectively |
| Last Modified On: |
10/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Menopausal Status on Dental Anxiety and Pain Perception in patients undergoing root canal treatment. |
|
Scientific Title of Study
|
Impact of Menopausal Status on Dental Anxiety and Pain Perception During Endodontic Management of Symptomatic Irreversible Pulpitis: An Observational Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alpa Gupta |
| Designation |
Professor |
| Affiliation |
Manav Rachna Dental College Faridabad,Haryana. India |
| Address |
Department of Conservative Dentistry and Endodontics
room No: 07, second floor
Faridabad Haryana India
Faridabad
HARYANA
121004
India |
| Phone |
9050312010 |
| Fax |
|
| Email |
alpagupta2008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Alpa Gupta |
| Designation |
Professor |
| Affiliation |
Manav Rachna Dental College Faridabad,Haryana. India |
| Address |
Department of Conservative Dentistry & Endodontics, Room No. 07, Second Floor
Faridabad Haryana India
Department of Conservative Dentistry & Endodontics, Room No. 07, Second Floor
Faridabad Haryana India
Faridabad
HARYANA
121004
India |
| Phone |
9050312010 |
| Fax |
|
| Email |
alpagupta2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Alpa Gupta |
| Designation |
Professor |
| Affiliation |
Manav Rachna Dental College Faridabad,Haryana. India |
| Address |
Department of Conservative Dentistry & Endodontics, Room No. 07, Second Floor
Faridabad Haryana India
Department of Conservative Dentistry & Endodontics, Room No. 07, Second Floor
Faridabad Haryana India
Faridabad
HARYANA
121004
India |
| Phone |
9050312010 |
| Fax |
|
| Email |
alpagupta2008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manav Rachna Dental College, Sector 43 Faridabad Haryana |
|
|
Primary Sponsor
|
| Name |
Alpa Gupta |
| Address |
Manav Rachna Dental College, sector 43, Faridabad Haryana |
| 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 Monika Tandan |
Manav Rachna Dental College |
Department of Conservative Dentistry and Endodontics, Room No. 07, second floor, Sector 43, suraj kund badhkal road, faridabad
Faridabad
HARYANA |
9999063631
monikatandan@mrei.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MANAV RACHNA DENTAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteer patients undergoing root canal treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
a) Female patients aged 18–65 years
b) Diagnosed with symptomatic irreversible pulpitis in mandibular molars.
c) Indicated for single-visit root canal treatment
d) ASA I / II
e) Willing to provide informed consent
|
|
| ExclusionCriteria |
| Details |
a) Pregnant or lactating women
b) Patients on hormone replacement therapy (HRT)
c) Patients with chronic pain disorders (fibromyalgia, migraine)
d) Psychiatric illness or use of anxiolytics/antidepressants
e) Previous endodontic treatment in the same tooth
f) Acute apical abscess or swelling
g) Uncontrolled systemic diseases (e.g., uncontrolled diabetes)
h) Previous traumatic dental experiences not related to menopause.
i) Patients who had taken analgesics or antibiotics 12 hours before the treatment
j) Teeth with calcified canals and aberrant root canal morphology, root resorption and prior endodontic intervention for same tooth
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Despite growing evidence that menopausal status affects pain thresholds and anxiety in medical settings, there is limited clinical data in dental and endodontic settings, particularly during acute pain conditions like SIP.
Understanding these differences can help clinicians tailor pain control strategies, communication, and anxiety management protocols in menopausal women.
|
6, 12, 24, 48 and 72 hours post treatment |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
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)
|
01/06/2026 |
| 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="2"
Months="0"
Days="0" |
|
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
|
The Prospective observational comparative study will be done in the department of conservative dentistry and endodontics, where 81 females are divided in 3 groups of 27 Premenopausal, 27 perimenopausal, & 27 post-menopausal participants each the study will be conducted over the period of 18 months. Female Patients with symptomatic irreversible pulpitis in mandibular molar teeth, ranging from 18—65 year of age will be selected based on the inclusion & exclusion criteria. Single sitting root canal treatment will be performed by the endodontists. The data in the form of scales will be recorded 1. Pre & Post modified dental anxiety scale, 2. HP VAS pain scale will be recorded at defined intervals of pre operative, during access cavity preparation, during root canal instrumentation, and post operatively (6 hour, 12, 24, 48 & 72 hours). |