| 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 |
|
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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 |
| 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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,kamineni institute of dental sciences |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
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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. |
|
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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
|
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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. |