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CTRI Number  CTRI/2022/04/041893 [Registered on: 18/04/2022] Trial Registered Prospectively
Last Modified On: 12/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   effect of blood cells derived gel on tooth pain  
Scientific Title of Study   EFFICACY OF PLATELET DERIVED GROWTH FACTOR GEL IN THE TREATMENT OUTCOME OF DENTINAL HYPERSENSITIVITY - A CLINICAL STUDY. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrLSwetha 
Designation  post graduate 
Affiliation  Kaloji Narayana Rao University, warangal 
Address  Room no:06 Department of Periodontics kamineni Institute of Dental Sciences,Sreepuram ,Narketpally,Nalgonda,508254.

Nalgonda
TELANGANA
508254
India 
Phone  9640401532  
Fax  8682272296  
Email  sonusonuind1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr G JAGADISH REDDY 
Designation  PROFESSOR 
Affiliation  Kaloji Narayana Rao University, warangal 
Address  Room no:06 Department of Periodontics Kamineni Institute of Dental Sciences,Sreepuram,Narketpally, Nalgonda,508254.

Nalgonda
TELANGANA
508254
India 
Phone  9949801470  
Fax    
Email  drjagadishreddy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Langer Swetha 
Designation  Post graduate 
Affiliation  Kaloji Narayana Rao University, warangal 
Address  Room no:06 Department of Periodontics kamineni Institute of Dental Sciences,Sreepuram,Narketpally, Nalgonda,508254.

Nalgonda
TELANGANA
500060
India 
Phone  9640401532  
Fax  8682272296  
Email  sonusonuind1@gmail.com  
 
Source of Monetary or Material Support  
Department of Periodontics,Kamineni Institute of Dental Sciences ,Narketpally,Nalgonda. Telangana 508254 
 
Primary Sponsor  
Name  Langer swetha 
Address  Room no:06 Department of Periodontics kamineni Institute of Dental Sciences, Sreepuram ,Narketpally, Nalgonda 
Type of Sponsor  Private medical college 
 
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 
Langer swetha  Kamineni Institute of Dental Sciences, Room no 6  Kamineni Institute of Dental Sciences Sreepuram,Narketpally,Nalgonda -508254.
Nalgonda
TELANGANA 
9640401532
8682272296
sonusonuind1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee,kamineni 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 
Comparator Agent  Periodontal Flap Surgery  At Initial phase patient is recalled for every seven days for three weeks and application of Citric Acid Root Modifying Agent followed by Novamin Tooth Paste on tooth surface and Assesment of Hypersensitivity has to be done during first week and then after four weeks Access Flap Surgery and Appication of Citric Acid Root Modifying Agent along with Novamin tooth paste on the Root Surface and Flap closure is done by placing Sutures and recalled after one week for suture removal and assesement of hypersensitivity has to be done 
Intervention  Periodontal Flap Surgery  At Initial phase patient is recalled for every seven days for three weeks and application of Citric Acid Root Modifying Agent followed by Platelet Derived Growth Factor Gel on tooth surface and assesment of Hypersensitivity has to be done during first week and then after four weeks Access Flap Surgery and Appication of Citric Acid Root Modifying Agent along with Platelet Derived Growth Factor gel on the Root Surface and Flap closure is done by placing Sutures and recalled after one week for suture removal and assesement of hypersensitivity has to be done 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion
Presence of maxillary or mandibular marginal tissue recession
2 . Age group is 18-60 yrs
3.systemically healthy patients 
 
ExclusionCriteria 
Details  1.systemically compromised patients.
2.using either homecare or inoffice desensitizing agents.
3.who underwent periodontal treatment last 6 months
4.opposing similar restorative material
5.dental carious lesion and endodontically treated tooth
6.non carious cervical lesions. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
relative attachment level
visual analog score
schiff sensitivity score 
baseline and 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
sensitivity reduction  1month 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   20/04/2022 
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="1"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Dentin hypersensitivity 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 defect or pathology.

Periodontal attachment loss could be an earlier indicator or a possible risk factor of dentin hypersensitivity . The management of dentinal hypersensitivity is primarily aimed at occluding the dentinal tubules or making coagulates inside the tubules. “At home” desensitizing agents include toothpastes, mouthwashes and chewing gums.

Root biomodifying agents has been advocated as an effective way to remove the smear layer and condition the roots for better regeneration. Root biomodification uses acid substances or chelating agents to remove the smear layer and expose root collagen fibers.

Platelet derived gowth factor (PDGF) stimulates angiogenesis, promotes cell migration into the bone defect from the surrounding tissue margins, and upregulates cell proliferation. The matrix, in addition to its role as a growth factor delivery vehicle, provides mechanical support for migrating cells and contributes to the formation of new bone, cementum and/or periodontal ligament.

Novamin® (calcium sodium phosphosilicate) is one such material, which reacts when exposed to the body fluids, and deposits hydroxycarbonate apatite, a mineral that is chemically similar to the mineral in enamel and dentin6.

Thus, the present study will be conducted to evaluate and compare effectiveness of recombinant human platelet derived growth factor gel and novamin desensitizing tooth paste in subjects with dentinal hypersensitivity.

 
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