| 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
|
|
|
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
|
|
|
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. |