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CTRI Number  CTRI/2024/07/070193 [Registered on: 08/07/2024] Trial Registered Prospectively
Last Modified On: 05/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treatment of periodontal defects with a combination of autologous blood products and antibiotics 
Scientific Title of Study   Comparative evaluation of efficacy of doxycycline incorporated platelet rich fibrin (PRF-D) versus platelet rich fibrin (PRF) alone in the treatment of intrabony defects - A randomized control clinical trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DOGIPARTHI MOUNICA 
Designation  POSTGRADUATE STUDENT 
Affiliation  SRI BALAJI DENTAL COLLEGE 
Address  DEPARTMENT OF PERIODONTOLOGY AND IMPLANTOLOGY, SRI BALAJI DENTAL COLLEGE, MOINABAD.

Hyderabad
TELANGANA
500075
India 
Phone  9491369451  
Fax    
Email  mounica.3m@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr HARITHA AVULA 
Designation  PROFESSOR AND HEAD OF THE DEPARTMENT 
Affiliation  SRI BALAJI DENTAL COLLEGE 
Address  DEPT OF PERIODONTOLOGY AND IMPLANTOLOGY, SRI BALAJI DENTAL COLLEGE, MOINABAD.

Hyderabad
TELANGANA
500075
India 
Phone  9885446656  
Fax    
Email  harithaavula@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DOGIPARTHI MOUNICA 
Designation  POSTGRADUATE STUDENT 
Affiliation  SRI BALAJI DENTAL COLLEGE 
Address  DEPTARTMENT OF PERIODONTOLOGY AND IMPLANTOLOGY, SRI BALAJI DENTAL COLLEGE, MOINABAD.

Hyderabad
TELANGANA
500075
India 
Phone  9491369451  
Fax    
Email  mounica.3m@gmail.com  
 
Source of Monetary or Material Support  
SRI BALAJI DENTAL COLLEGE, DEPARTMENT OF PERIODONTICS AND IMPLANTOLOGY, YENKAPALLY VILLAGE, MOINABAD MANDAL, HYDERABAD, cOUNTRY: INDIA. PINCODE: 500075. 
 
Primary Sponsor  
Name  DOGIPARTHI MOUNICA 
Address  DEPARTMENT OF PERIODONTICS AND IMPLANTOLOGY, SRI BALAJI DENTAL COLLEGE, MOINABAD. 
Type of Sponsor  Other [SELF] 
 
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 Dogiparthi Mounica  SRI BALAJI DENTAL COLLEGE  DEPARTMENT OF PERIODONTICS AND IMPLANTOLOGY, Sri Balaji dental college, Moinabad, Hyderabad.
Hyderabad
TELANGANA 
9491369451

mounica.3m@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI BALAJI DENTAL COLLEGE -INSTITUTIONAL ETHICAL COMMITTEE  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  DOXYCYCLINE  DOXYCYCLINE INCORPORATED PLATELET RICH FIBRIN IN TREATMENT OF INTRABONY DEFECTS. DOSAGE - 0.5mg/ml-1.0mg/ml. PRF WITH DOXYCYCLINE WILL BE ADDED DURING THE SURGICAL PROCEDURE, DURATION OF THE ENTIRE STUDY IS 2 YEARS.  
Comparator Agent  PLATELET RICH FIBRIN  OPEN FLAP DEBRIDEMENT WITH PLATELET RICH FIBRIN IN THE TREATMENT OF INTRABONY DEFECTS. DURATION OF THE ENTIRE STUDY IS TWO YEARS 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Periodontitis patients with the presence of intra-bony defect (IBD) ≥3 mm deep (distance between alveolar crest and base of the defect) on an intraoral periapical radiograph [IOPA].
2.Interproximal probing depth (PD) ≥5 mm after phase I therapy in asymptomatic maxillary/ mandibular molar teeth.
 
 
ExclusionCriteria 
Details  1.Patients with systemic conditions known to affect the periodontal status.
2.Patients taking medications known to affect the outcomes of periodontal therapy.
3.Pregnant and lactating women.
4.Teeth with furcation defects, non-vital teeth, and mobility of at least grade II.
5.History of periodontal surgery in past one year.
6.Patients with unacceptable oral hygiene.
7.Smokers.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Linear bone growth
2.Wound healing index 
10 days, 1 month, 6 months, 9 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.Probing depth reduction
2.Relative attachment level gain
3.Full mouth bleeding scores
4.Full mouth plaque scores
5.Modified gingival index
6.Gingival margin position
7.Alveolar crest position 
Baseline, 3, 6 and 9 months 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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 2 
Date of First Enrollment (India)   14/10/2024 
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="2"
Months="0"
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  

Periodontal treatment aims at treating the infection caused by pathogenic bacterial biofilm, arresting the progression of disease and reconstituting the structures of the periodontium that are lost, ultimately preventing tooth loss. Regeneration is the ultimate goal of periodontal therapy. 

Currently a novel approach to attain periodontal regeneration is the use of Platelet rich fibrin (PRF), that releases polypeptide growth factors (PGFs) which have the ability to regulate cell proliferation, chemotaxis, and differentiation, that may directly contribute to formation of new tissues. PRF is a biomimetic agent which shows favourable results in regeneration of periodontal tissues when used alone or as a combination therapy.

Post-operative microbial colonization can hamper the outcomes of periodontal regenerative therapy. Incorporation of PRF with antibiotics could be a beneficial approach in terms of minimizing the microbial burden and enhancing the results of regenerative procedures.

Doxycycline is proven to be an effective antibiotic against periodontal pathogens and also has an additional benefit of possessing anti-collagenolytic property. Therefore, a combination of platelet rich fibrin and doxycycline can be hypothesized as a promising technique to aid in periodontal regeneration and also to reduce bacterial colonization.

 
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