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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 
 
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