| CTRI Number |
CTRI/2024/09/074279 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision of two commercially available Sensitivity toothpastes in reducing Dental hypersensitivity after Teeth cleaning. |
|
Scientific Title of Study
|
Comparative evaluation of Calcium sodium phospho silicate dentifrice (CSPS) and Nano-hydroxy apatite dentifrice (NHA) in reducing Dentinal hypersensitivity after Scaling and Root planing. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GUMMADI TEJASREE |
| Designation |
Post Graduate |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Department of periodontics, room no 8, 2nd floor, Sibar institute of dental sciences, Takkellapadu, Guntur
Guntur ANDHRA PRADESH 522509 India |
| Phone |
9912837197 |
| Fax |
|
| Email |
gummadits@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dhulipalla ravindranath |
| Designation |
Professor and HOD |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Department of periodontics, room no 8, 2nd floor, Sibar institute of dental sciences, Takkellapadu, Guntur
ANDHRA PRADESH 522509 India |
| Phone |
9849222259 |
| Fax |
|
| Email |
ravident69@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
GUMMADI TEJASREE |
| Designation |
Post Graduate |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Department of periodontics, room no 8, 2nd floor, Sibar institute of dental sciences, Takkellapadu, Guntur
ANDHRA PRADESH 522509 India |
| Phone |
9912837197 |
| Fax |
|
| Email |
gummadits@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sibar institute of dental sciences, takkellapadu, guntur, 522509.
Andhra pradesh. |
|
|
Primary Sponsor
|
| Name |
Sibar institute of dental sciences |
| Address |
Sibar institute of dental sciences, Takkellapadu, Guntur, 522509 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Gummadi Tejasree |
Sibar institute of dental sciences |
Department of periodontics, room no 8, 2nd floor, Sibar institute of dental sciences, takkellapadu, guntur, 522509.
Guntur
ANDHRA PRADESH Guntur ANDHRA PRADESH |
9912837197
gummadits@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
| Intervention |
Calcium sodium phosphosilicate |
Calcium sodium phosphosilicate, a bioactive glass, reacts when exposed to aqueous media and
provides calcium and phosphate ions that form a hydroxyl carbonate, a mineral that is chemically similar to the mineral in enamel and dentin. The chemical reaction initiated by calcium sodium
phosphosilicate to promote the formation of a hydroxyl carbonate layer for the treatment of Dentine hypersensitivity
is also useful in treating demineralized tooth structure or in preventing further demineralization. 2 mg of the tooth paste is applied on the tooth and polished for 30 seconds using micromotor and polishing bur. |
| Comparator Agent |
Nano-hydroxy apatite |
Synthetic carbonate hydroxyl-apatite nanocrystals have been shown to produce re-mineralization of the altered enamel surfaces and to be effective in closing dentinal tubules. The mechanism of action is based on occluding the dentinal tubules to block the hydrodynamic mechanism and pain stimulation by depositing a thin coating, or artificial smear layer, on the exposed dentin. Also, remineralizing the exposed dentin surface with deposits or precipitation of fine particles work to occlude the dentinal tubules. 2 mg of the tooth paste is applied on the tooth and polished for 30 seconds using micromotor and polishing bur. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who underwent scaling and root planing.
Subjects with Schiff score of 2-3 for atleast two teeth after scaling and root planing.
Subjects with VAS score of more than 4 for atleast two teeth after scaling and root planing.
Subjects willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Subjects with dentinal hypersensitivity prior to scaling and root planing.
Subjects who are using agents to treat hypersensitivity in the past 3 months.
Subjects having pharmacotherapeutic histories that may compromise the protocol,
including chronic use of anti-inflammatory, analgesic, or mind-altering drugs, and
allergic to the test products (CSPS or NHA).
Dentin hypersensitivity caused by dental caries, defective restorations, fractured tooth,
abrasion or abfraction, extensively restored teeth, orthodontic treatment within the past 3
months, crowded teeth, or abutment teeth for fixed or removable prosthesis. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare Schiff score and visual analog score in both groups. |
baseline, after application, 2 weeks, 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| schiff score, visual analog score. |
Baseline, after application, 2 weeks, 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="16" Sample Size from India="16"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
08/10/2024 |
| Date of Study Completion (India) |
24/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="2" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Dentine hypersensitivity (DH) is characterized by short, sharp pain arising from exposed dentine
in response to stimuli, typically thermal, evaporative, tactile, osmotic or chemical and which
cannot be ascribed to any other dental defects or pathology. The diagnosis of this disease is often
based on the subject’s self report of pain and requires exclusion of other dental and periodontal
conditions that might cause pain. The successful treatment of periodontal disease depends on the effective removal of bacterial
deposits from the tooth surfaces. This can be accomplished by thorough daily oral hygiene
measures achieved by the patient and by professionally performed mechanical debridement.
However, the establishment of healthy periodontal conditions by active treatment may often
result in receding of the gingival tissues, leaving root surfaces exposed to the oral environment.
The iatrogenic denudation of root dentin due to removal of the cementum layer is yet another
complication to scaling procedures. The ultimate goal for treating DH is immediate relief with a long-lasting action. The efficacy of desensitizing
agent’s that blocks the pain stimulus such as potassium or strontium-containing dentifrices is
limited. Therefore, desensitizing agents that can occlude tubules and resist chemical substances
and abrasion have been developed. Calcium sodium phosphosilicate, a bioactive glass, reacts when exposed to aqueous media and
provides calcium and phosphate ions that form a hydroxyl carbonate, a mineral that is chemically
similar to the mineral in enamel and dentin. The chemical reaction initiated by calcium sodium
phosphosilicate to promote the formation of a hydroxyl carbonate layer for the treatment of DH
is also useful in treating demineralized tooth structure or in preventing further demineralization. Synthetic carbonate hydroxyl-apatite nanocrystals have been shown to produce re-mineralization
of the altered enamel surfaces and to be effective in closing dentinal tubules. The mechanism of
action is based on occluding the dentinal tubules to block the hydrodynamic mechanism and pain
stimulation by depositing a thin coating, or artificial smear layer, on the exposed dentin. Also,
remineralizing the exposed dentin surface with deposits or precipitation of fine particles work to
occlude the dentinal tubules. Patients will be receiving phase I therapy which includes scaling and root planing and
thorough oral hygiene instructions will be given. Patients will be assessed for eligibility after 1 week. Parameters such as Schiff score; visual analog score will be measured at baseline. The dentifrice is applied to the teeth using a rubber cup with a low speed hand piece. Then two consecutive 3- second applications focusing on exposed cementum and dentine
will be done. The clinical parameters were re-assessed immediately after the application. The participants were instructed about the home use of their dentifrice. Each participant will be given a new soft toothbrush and a tube of the assigned dentifrice. They will be informed to use only the toothbrush and dentifrice provided for the trial and
instructed to not use a mouthwash while participating in this study. The home care instructions will be given, which comprises brushing twice daily using the
modified bass technique with a 1-inch strip of the dentifrice for 2 minutes and rinsing one
time with water. Patient will be recalled after 2 and 4 weeks parameters will be re-assessed. Follow up will be done at 2 weeks and 4 weeks for parameters. |