| CTRI Number |
CTRI/2025/05/087069 [Registered on: 16/05/2025] Trial Registered Prospectively |
| Last Modified On: |
10/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of Advanced Platelet-Rich Fibrin (A-PRF) as an Adjunct to Scaling and Root Planing in Periodontitis Patients with Type 2 Diabetes Mellitus: A Randomized Clinical Study |
|
Scientific Title of Study
|
Evaluation of Advanced Platelet-Rich Fibrin (A-PRF) as an Adjunct to Scaling and Root Planing in Periodontitis Patients with Type 2 Diabetes Mellitus: A Randomized 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 |
Dr Anubha Singh |
| Designation |
Post Graduate Student |
| Affiliation |
AB Shetty Memorial Institute Of Dental Sciences |
| Address |
Dr Anubha Singh, Department Of Periodontology ,ABShetty Institute Of Medical Sciences, Mangalore
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9538898868 |
| Fax |
|
| Email |
anubhasingh08031997@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof (Dr) Santhosh Shenoy |
| Designation |
Additional professor |
| Affiliation |
AB Shetty Memorial Institute Of Dental Sciences |
| Address |
Prof(Dr) Santhosh Shenoy, Additional Professor, Department Of Periodontology, ABShetty Institute Of Medical Sciences, Mangalore
Dakshina Kannada KARNATAKA 575022 India |
| Phone |
9448104417 |
| Fax |
|
| Email |
drsanthoshshenoy@nitte.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Anubha Singh |
| Designation |
Post Graduate Student |
| Affiliation |
AB Shetty Memorial Institute Of Dental Sciences |
| Address |
Dr Anubha Singh, Department Of Periodontology ,ABShetty Institute Of Medical Sciences, Mangalore
KARNATAKA 575018 India |
| Phone |
9538898868 |
| Fax |
|
| Email |
anubhasingh08031997@gmail.com |
|
|
Source of Monetary or Material Support
|
| dr Anubha Singh AB SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES ,DERALAKATTE,MANGALORE,Karnataka,575022 |
|
|
Primary Sponsor
|
| Name |
Dr Anubha Singh |
| Address |
Dr Anubha Singh, Department Of Periodontology ,ABShetty Institute Of Medical Sciences, Deralakatte, Mangalore,Karnataka,India
575022 |
| Type of Sponsor |
Other [self sponsored] |
|
|
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 Anubha Singh |
A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES |
DEPARTMENT OF PERIODONTOTLOGY,A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES,DERALAKATTE,MANGALORE
Dakshina Kannada
KARNATAKA Dakshina Kannada KARNATAKA |
9538898868
anubhasingh08031997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Advanced platelet rich fibrin (A-PRF) |
10 ml of peripheral blood will be drawn from the antecubital vein of each patient into sterile non-coated plastic vacutainers without any anticoagulants. A-PRF produced by Duo Quattro with a 40-degree rotor angulation and a radius of 88mm to the minimum and 110 to the maximum at 1300 rpm for 8 min. A-PRF membranes will be created in the 10 ml test tube. After centrifugation, three different layers formed in each Tarsons 15ml graduated centrifuge tube from bottom to top as follows: red blood cell clot, platelet-rich fibrin clot and liquid plasma layer. The fibrin clot will be then held with anatomical tweezers and separated from the other two layers with surgical scissors. Afterward, It will be placed in a PRF box and pressed between two flat metal plates which will transform it into a membrane. The membrane will be cut into even pieces. A-PRF will be placed in the Test site using packing instruments after scaling and root planning. After scaling and root planning, the control sites will be treated with saline in a similar manner for the placebo effect. |
| Comparator Agent |
Scaling and Root planning |
After screening examination random sites
in split mouth are allocated as test and the
contralateral site is allocated as control.Patient will undergo full
mouth scaling and root
planning followed by
saline irrigation in both the test and control site. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
stage III periodontitis.
2 single rooted teeth in different quadrants.
periodontal destruction in more than 2 interproximal sites in non adjacent sites.
patient willing to attend 3 month and 6 month follow up.
|
|
| ExclusionCriteria |
| Details |
pregnant or lactating women.
current smokers
patients with any other systemic diseases(cardiovascular disease, autoimmune disorders platelet disorders)
taking medications that affect wound healing (bisphosphonates, high-dose steroids.
history of periodontal treatment within 6 months.
history of radiotherapy or chemotherapy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Periodontal Pocket Depth (PPD)
Clinical Attachment Loss
Visual Analogue scale (VAS)score
|
1 week, 3 months and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue scale (VAS)score |
1 week. |
|
|
Target Sample Size
|
Total Sample Size="110" Sample Size from India="110"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/05/2025 |
| 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 Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anubhasingh08031997@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The periodontium consists of tissues that support the dentition, including the gingiva, periodontal ligament, and alveolar bone. Periodontal health relies on maintaining host-microbe homeostasis, which is disrupted in diabetes mellitus, leading to accelerated periodontal destruction and impaired wound healing. The initial step in periodontal disease treatment involves professional cleaning through scaling and root planing (SRP) to remove supra- and subgingival plaque and calculus, followed by evaluation. Various therapeutic approaches have been suggested to enhance SRP outcomes and minimize surgical interventions. Advanced Platelet-Rich Fibrin (A-PRF) has shown promising potential in wound healing and tissue regeneration through the sustained release of growth factors. The fibrin structure in A-PRF, characterized by thick fibers, branch points, porosity, and permeability, enhances wound stabilization. This randomized split-mouth study will evaluate the efficacy of A-PRF as an adjunct to SRP in diabetic patients, with test sites receiving A-PRF while control sites undergo SRP alone.
The study aims to compare the effectiveness of A-PRF in conjunction with SRP in Type II diabetic patients with periodontitis. The objectives include assessing the effectiveness of A-PRF combined with SRP, evaluating SRP alone, and comparing the outcomes of both treatments. Inclusion criteria include patients aged 30-60 years with Type II diabetes and diagnosed with stage III periodontitis (5-7mm probing pocket depth and attachment loss). Patients must require periodontal treatment for at least two single-rooted teeth in different quadrants and have periodontal destruction at two non-adjacent interproximal sites. Exclusion criteria include pregnancy, smoking, systemic diseases, medications affecting wound healing, recent periodontal treatment, and a history of radiotherapy or chemotherapy. The study follows a randomized split-mouth design with 50 test and 50 control teeth. The sample size is calculated as 110, considering a 10% attrition rate, with a 95% confidence level and pooled standard deviation estimates of 0.66 (Group I) and 0.54 (Group II).
The methodology includes fabricating acrylic stents, conducting blood tests, preparing A-PRF, and documenting periodontal clinical parameters such as the Gingival Index, probing pocket depth (PPD), and clinical attachment level (CAL) using a UNC-15 probe and acrylic stent for standardization. A Visual Analogue Scale (VAS) will be recorded for pain assessment. All patients will undergo full-mouth SRP, with test sites receiving subgingival A-PRF and both test and control sites covered with COE-PAK periodontal dressing. Periodontal assessments will be conducted at 1 week, 3 months, and 6 months. Data will be analyzed using SPSS version 22.0, with ANOVA and Independent ’t’ tests used for group comparisons. A p-value of <0.05 will be considered statistically significant, and Karl Pearson correlation will assess relationships between variables. |