| CTRI Number |
CTRI/2024/07/070472 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To assess the role of human placental extract in treating periodontitis |
|
Scientific Title of Study
|
Effects of Professional Mechanical Plaque Removal and Human Placental Extract on Gingival Crevicular Fluid levels of Matrix Metalloproteinase-8 in Patients with Stage II Grade A/B Periodontitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tamil Selvan M D |
| Designation |
PG student |
| Affiliation |
Adhiparasakthi Dental College and Hospital |
| Address |
Department of Periodontics, Adhiparasakthi Dental College and Hospital, Melmaruvathur , Tamil Nadu - 603319
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
8220725185 |
| Fax |
|
| Email |
mail4tamizhmohan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Gnanasagar W R |
| Designation |
Associate Professor |
| Affiliation |
Adhiparasakthi Dental College and Hospital |
| Address |
Department of Periodontics, Adhiparasakthi Dental College and Hospital, Melmaruvathur , Tamil Nadu - 603319
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9003209886 |
| Fax |
|
| Email |
gnanasagar.perio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tamil Selvan M D |
| Designation |
PG student |
| Affiliation |
Adhiparasakthi Dental College and Hospital |
| Address |
Department of Periodontics, Adhiparasakthi Dental College and Hospital, Melmaruvathur , Tamil Nadu - 603319
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
8220725185 |
| Fax |
|
| Email |
mail4tamizhmohan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Adhiparasakthi Dental College and Hospital, Melmaruvathur , Tamil Nadu - 603319 |
|
|
Primary Sponsor
|
| Name |
Tamil Selvan M D |
| Address |
Adhiparasakthi Dental College and Hospital, Melmaruvathur , Tamil Nadu - 603319 |
| 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 Tamil Selvan M D |
Adhiparasakthi Dental College and Hospital, |
Department of Periodontics
Kancheepuram
TAMIL NADU |
8220725185
mail4tamizhmohan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Adhiparasakthi Dental College and Hospital , Melmaruvathur - 603319 |
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 |
Human Placental extract |
Placentrex – the original research product of
Albert David Limited, India, a drug obtained from
fresh term healthy human placentae will be placed as a Local drug delivery at Baseline |
| Comparator Agent |
SRP |
Scaling and Root planing with Ultrasonic and hand instruments will be peformed at baseline. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Age: 20-45 years
2.Presence of 20 or more natural teeth
3.Localised Stage I/II Grade A/B Periodontitis(AAP
2017) [Presence of localised Supra bony pocket of
4-6mm] |
|
| ExclusionCriteria |
| Details |
1.Patients with Systemic illness
2.Patients with Molar/Incisor pattern Periodontitis
3.Pregnant and Lactating women
4.Patients using Smoking and Smokeless tobacco
5.Patient under local or systemic antibiotic or anti
inflammatory therapy in past 3 months |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Probing Pocket Depth and Gain in Clinical attachment levels |
Baseline and 2 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Gingival index & Plaque Index scores |
Baseline & 2 Months |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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 3 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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
|
Out Patients reporting to Department of Periodontics and Implantology, Adhiparasakthi Dental College and Hospital aged between 20-45 years diagnosed with Localised Stage II Grade A/B Periodontitis and meeting the inclusion and exclusion criteria will be included for the study.The nature of the study and the procedure will be explained to the patient in the vernacular language and written informed consent will be obtained from the patients who are willing to participate.
Following the sample selection, the Sites will be randomly assigned to either the Test group(Group A) or the Control group(Group B).
In Group A patients, Clinical parameters including Gingival index, Plaque index, Probing Pocket depth & Clinical attachment level were recorded using UNC 15 probe at baseline. Probing will be conducted at six sites around the tooth. The sites exhibiting the deepest PD and the greatest CAL will be chosen, and the same site will be considered during subsequent follow-up visits. At baseline, GCF collection will also be done. The selected test site will be air-dried and isolated using sterile cotton rolls. Supragingival plaque will be removed gently without touching the marginal gingiva to prevent bleeding from gingiva. By using an extracrevicular (unstimulated) method, a standardised volume of 3μL of GCF will be collected from the selected site with a 1-5 μL calibrated volumetric microcapillary pipette. The collected GCF will be transferred to eppendorf tubes containing 0.5 mL of phosphate buffer saline and stored at -70 °C until the time of assay. Only the samples devoid of visible contamination with blood or plaque will be considered for the study. After the baseline (D0) GCF sampling and clinical parameter recording, a patients will undergo thorough ultrasonic supragingival and subgingival mechanical plaque removal using Ultrasonic scaler(Woodpecker) and hand instruments (Hufriedy Universal curette 2R/2L,4R/4L) followed which 1ml of human placental extracts gel (Placentrex – the original research product of Albert David Limited, India, a drug obtained from fresh term healthy human placentae) adsorbed in gelatin foam will be placed in the Pocket. Post Operative instructions will be given.
In Group B patients, Clinical parameters(Gingival index, Plaque index, Probing Pocket depth & Clinical attachment level) will be recorded using UNC 15 probe at baseline at the selected site. At the selected tooth, probing was done at six sites. The sites that showed the deepest PD and the greatest CAL were chosen, and the same site was considered during follow-up visits. At baseline, GCF collection will also be done. The selected test site will be air-dried and isolated with sterile cotton rolls. Supragingival plaque will be removed gently without touching the marginal gingiva to prevent bleeding from gingiva. Utilising an extracrevicular (unstimulated) method, a standardised volume of 3 μL of GCF will be collected from the selected site with a 1-5 μL calibrated volumetric microcapillary pipette. The collected GCF will be transferred to eppendorf tubes containing 0.5 mL of phosphate buffer saline and promptly stored at -70 °C until the time of assay. Only the samples devoid of visible contamination with blood or plaque were considered for the study. After the baseline (D0) GCF sampling and clinical parameter recording, patients will undergo only thorough ultrasonic supragingival and subgingival mechanical plaque removal with Ultrasonic scaler(Wood Pecker) and hand instruments (Hu-friedy Universal curette 2R/2L,4R/4L).
Oral hygiene instructions will be given to the patients.
Recall appointments will be scheduled after 2months for follow-up. During the recall visit, GCF sampling and clinical parameter recordings will be repeated.GCF samples will be analysed for MMP8 levels using ELISA MMP8 assay Kit.
Recorded Clinical data and analysed GCF MMP 8 levels will be tabulated and subjected to statistical analysis.
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