| CTRI Number |
CTRI/2024/01/061186 [Registered on: 08/01/2024] Trial Registered Prospectively |
| Last Modified On: |
01/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the study between two blood products to form new bone. |
|
Scientific Title of Study
|
Comparative Evaluation of concentrated growth factor with platelet rich fibrin for the treatment of infrabony defects- A randomized controlled study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Angela Johnson |
| Designation |
Post graduate student |
| Affiliation |
K M Shah dental college and hospital |
| Address |
Sumandeep vidyapeeth At and Po pipariya, Ta.Waghodia dist.Vadodara
Room no. 7, Department of Periodontology, K.M Shah dental college and hospital,Sumandeep vidyapeeth AT And PO Pipariya, TA.Waghodia Dist.vadodara, gujarat- 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9702004902 |
| Fax |
|
| Email |
angelajohnson250796@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Monali Shah |
| Designation |
HOD, professor and Guide |
| Affiliation |
K M Shah dental college and hospital |
| Address |
Sumandeep vidyapeeth At and Po pipariya, Ta.waghodia dist.Vadodara
Room no. 7, Department of periodontology, K.M Shah dental college and hospital,Sumandeep vidyapeeth At and Po pipariya, Ta.Waghodia dist.vadodara, gujarat- 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9824003228 |
| Fax |
|
| Email |
smonali2011@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Angela Johnson |
| Designation |
Post graduate student |
| Affiliation |
K M Shah dental college and hospital |
| Address |
Sumandeep vidyapeeth AT and PO pipariya, TA.waghodia dist.vadodara
Room no. 7, department of periodontology, K.M Shah dental college and hospital,Sumandeep vidyapeeth AT and PO pipariya, TA.waghodia dist.vadodara, gujarat- 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9702004902 |
| Fax |
|
| Email |
angelajohnson250796@gmail.com |
|
|
Source of Monetary or Material Support
|
| KM Shah dental college and hospital,sumandeep vidyapeeth At and Po pipariya, Ta.waghodia dist.vadodara, gujarat-391760 |
|
|
Primary Sponsor
|
| Name |
Dr Angela Johnson |
| Address |
Sumandeep vidyapeeth At and Po pipariya, Ta.waghodia dist.vadodara- 391760, gujarat |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Monali Shah |
Room No. 7, Department of periodontology, KM Shah dental college and hospital, Sumandeep University, Pipariya, Waghodia Road, Vadodara, Gujarat-391760. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Angela Johnson |
KM Shah dental college and hospital |
Room no. 7, department of periodontology, 2nd floor.
Vadodara
GUJARAT |
9702004902
angelajohnson250796@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics 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 |
Concentrated growth factors |
Concentrated growth factor promote periodontal regeneration and is used in the treatment of periodontal intrabony defects.
It is an excellent material for enhancing bone healing. |
| Comparator Agent |
Platelet Rich Fibrin |
It is an autologous non- transfusional hemo-component. The dense fibrin matrix contains leukocytes, platelets, and growth factors, and it can be employed as a biomaterial for healing. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Systemically healthy Participants diagnosed with localized or generalized Stage II/III
periodontitis within the age group of 18-50 years.
2. Participants with at least one tooth with probing depth (PPD) > 5mm and presence of
infrabony component (IC) >3mm site after phase I therapy. |
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women
2. Medications which interfere with platelet
function within last three months and
antibiotics taken within 1 month prior to
treatment.
3. Patients with systemic disease.
4. History of Smoking or tobacco consumption.
5. Patients with poor oral hygiene or previous
lack of cooperation with the maintenance
program. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Relative attachment levels
2.Probing depth
3.Bleeding index
|
Baseline - on the day of the surgery and at 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Radiographic bone level
2.Bone fill % |
Baseline - on the day of the surgery and at 3 months |
|
|
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)
|
11/01/2024 |
| 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="1"
Months="6"
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
|
Periodontitis is a chronic, inflammatory, non-communicable condition that damages the periodontium in all ways and cannot be reversed. It is a localized inflammatory response caused by bacterial infection of a periodontal pocket associated with subgingival plaque.The early stages of the disease (gingivitis), inflammation is limited to the gingiva, but in periodontitis, it spreads to deeper tissues, causing swelling, bleeding, and poor smell in the gingiva. When the condition progresses, the periodontium’s supporting collagen degenerates, alveolar bone starts to resorb, and gingival epithelium migrates along the tooth’s surface to produce a "periodontal pocket. The course of periodontitis starts with pocket formation induced by bacterial plaque and a subsequent alveolar bone destruction typical of chronic periodontitis. Bone destruction during periodontitis can be of different morphological patterns including horizontal defects and vertical defects. Periodontal defects can be differentiated based on bone resorption patterns into ‘supraosseous’ (‘suprabony’) and ‘infraosseous’ (‘infrabony’). An infrabony defect is the anatomical consequence of the dental plaque’s apical advancement during the course of the disease. Suprabony defects are those in which the base of the pocket is positioned proximal to the alveolar crest. On the other hand, infrabony defects are those in which the base of the pocket is located apically in relation to the bone crest.Such defects, if left untreated, easily promote periodontitis progression and further loss of attachment. There are many surgical procedures have been developed in an effort to treat periodontitis effectively. One of the earliest and most promising techniques is open flap debridement (OFD). Open flap debridement (OFD) has been shown to result in successful treatment of intrabony defects. A high concentration of platelets make up platelet-rich fibrin (PRF), an autologous non- transfusional hemo-component. The dense fibrin matrix contains leukocytes, platelets, and growth factors, and it can be employed as a biomaterial for healing. PDGF-AB (platelet- derived growth factor AB), TGFß-1 (transforming growth factor ß-1), and VEGF are all found in platelets (vascular endothelial growth factor). These growth factors promote angiogenesis, matrix remodelling, and cell proliferation. Concentrated growth factor (CGFs) are a new generation of platelets concentrates, which contain abundant growth factor. CGFs promote periodontal regeneration and is used in the treatment of periodontal intrabony defects. Concentrated growth factor (CGF) is an excellent material for enhancing bone healing and stimulatory effect on angiogenesis and epithelialization. So concentrated growth factor can be used for the treatment of infrabony defects. |