| CTRI Number |
CTRI/2025/02/080431 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
09/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Gluma and Potassium Oxalate for Dentinal Hypersensitivity |
|
Scientific Title of Study
|
Evaluation and Comparison of Gluma Desensitizer and Potassium Oxalate Desensitizer in the Treatment of Dentinal Hypersensitivity Induced by 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 |
Prachi Jain |
| Designation |
Post graduate student |
| Affiliation |
Government Dental College And Hospital Jamnagar |
| Address |
Department of Periodontology, Room No.6,Government Dental College and Hospital Main Road Rameshwar Nagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9265704053 |
| Fax |
|
| Email |
jprachi0497@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prachi Jain |
| Designation |
Post graduate student |
| Affiliation |
Government Dental College And Hospital Jamnagar |
| Address |
Department of Periodontology, Room No.6,Government Dental College and Hospital Main Road Rameshwar Nagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9265704053 |
| Fax |
|
| Email |
jprachi0497@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prachi Jain |
| Designation |
Post graduate student |
| Affiliation |
Government Dental College And Hospital Jamnagar |
| Address |
Department of Periodontology, Room No.6,Government Dental College and Hospital Main Road Rameshwar Nagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9265704053 |
| Fax |
|
| Email |
jprachi0497@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology, Room No.6,Government Dental College and Hospital Main Road Rameshwar Nagar , Jamnagar, India, Pincode-361008 |
|
|
Primary Sponsor
|
| Name |
Dr Prachi Jain |
| Address |
Department of Periodontology, Room No.6,Government Dental College and Hospital Main Road Rameshwar Nagar , Jamnagar, India, Pincode-361008 |
| 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 Prachi Jain |
Government Dental College and Hospital, Jamnagar |
Department of Periodontology, Room No.6, GDCHJ, Navagam.
Jamnagar
GUJARAT
Jamnagar
GUJARAT |
9265704053
jprachi0497@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee M.P. Shah Medical College and Guru Gobindsingh Hospital |
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 |
Gluma desensitizer |
Patients were recalled after one week of periodontal therapy. Patients fulfilling the inclusion criteria were selected for the study. Hypersensitivity was checked immediate post operative, after 1 week, with three stimuli i.e.; tactile, cold, air stimulus with the help of visual analogue scale (VAS scale) with a 5 min gap between each stimulus.
• Tactile stimulus- The University of North Carolina-15 probe(UNC-15) tip was moved in mesio-distal direction in contact with the buccal tooth surface of the tooth and VAS score was recorded.
• Cold stimulus- After isolating the hypersensitive tooth, a 2-ml disposable syringe with needle (24 gauze) was filled with freshly melted ice-cold water from which 0.5 ml of the water was expelled from the syringe onto the tooth surface and VAS score was recorded.
• Air blast stimulus- Three-way syringe attached to the dental chair was used, keeping a distance of 1 cm, perpendicular to the tooth surface for 3 seconds per tooth and VAS score was recorded.
• After recording the VAS score, the quadrant was allocated with envelope method for the application of Gluma desensitizer .the agent was applied only once at one week period and was kept for 1 minute after which it was washed with the help of water.The solution was applied as per the instruction provided by the manufacturer by using a small brush applicator. Patients were recalled as per the schedule for recording the VAS score to evaluate the degree of hypersensitivity. After completion of all VAS tests scores data were assessed.
|
| Intervention |
Potassium oxalate desensitizer |
Patients were recalled after one week of periodontal therapy. Patients fulfilling the inclusion criteria were selected for the study. Hypersensitivity was checked immediate post operative, after 1 week, with three stimuli i.e.; tactile, cold, air stimulus with the help of visual analogue scale (VAS scale) with a 5 min gap between each stimulus.
• Tactile stimulus- The University of North Carolina-15 probe(UNC-15) tip was moved in mesio-distal direction in contact with the buccal tooth surface of the tooth and VAS score was recorded.
• Cold stimulus- After isolating the hypersensitive tooth, a 2-ml disposable syringe with needle (24 gauze) was filled with freshly melted ice-cold water from which 0.5 ml of the water was expelled from the syringe onto the tooth surface and VAS score was recorded.
• Air blast stimulus- Three-way syringe attached to the dental chair was used, keeping a distance of 1 cm, perpendicular to the tooth surface for 3 seconds per tooth and VAS score was recorded.
• After recording the VAS score, the quadrant was allocated with envelope method for the application of Potassium oxalate desensitizer.the agent was applied only once at one week period and was kept for 1 minute after which it was washed with the help of water .The solution was applied as per the instruction provided by the manufacturer by using a small brush applicator. Patients were recalled as per the schedule for recording the VAS score to evaluate the degree of hypersensitivity. After completion of all VAS tests scores data were assessed.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age ranging from 20 to 60 years.
Patients diagnosed with chronic periodontitis and indicated for non surgical or surgical periodontal therapy, complaining of dentin hypersensitivity after treatment on the 7th postoperative day.
Willing to provide informed consent for being included in the study.
the presence of a minimum of two teeth, hypersensitive to tactile, cold or air stimulation corresponding to 2 cm and above on the visual analog scalein two quadrants.
|
|
| ExclusionCriteria |
| Details |
Patients who had received any professional treatment with desensitizing agents during the past 6 months.
Hypersensitivity before undergoing periodontal therapy.
Any carious lesions, extensive restorations, endodontic treatment on the selected teeth, teeth diagnosed to have cracked tooth syndrome, vertical fracture and pulpitis.
Pregnant and lactating women.
Patients with deleterious oral habits such as smoking, tobacco chewing.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the reduction in dentinal hypersensitivity following periodontal therapy, as measured by patient-reported pain scores and objective sensitivity tests (such as air blast, tactile, or thermal stimulation) |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the reduction in dentinal hypersensitivity following periodontal therapy, as measured by patient-reported pain scores and objective sensitivity tests (such as air blast, tactile, or thermal stimulation) |
1 month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
20/02/2025 |
| 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="6"
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
|
| Written informed consent was obtained from all study participants before starting the study.The quadrants were randomly allocated with envelope method into the following groups:Group A- Gluma desensitizer quadrantGroup B- Potassium oxalate desensitizer quadrantPatients were recalled after one week of periodontal therapy. Patients fulfilling the inclusion criteria were selected for the study. Hypersensitivity was checked immediate post operative, after 1 week, after 2 weeks, after 1 month and after 3 months with three stimuli i.e.; tactile, cold, air stimulus with the help of visual analogue scale (VAS scale) with a 5 min gap between each stimulus. | |