| CTRI Number |
CTRI/2024/10/074907 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of Stage II Periodontitis with injectable Platelet rich fibrin or Ozonated olive oil gel after teeth cleaning. |
|
Scientific Title of Study
|
Clinical efficacy of injectable Platelet rich fibrin and Ozonated olive oil gel as an adjunctive to Non-surgical periodontal therapy in Stage II Periodontitis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhimavarapu Sumanth |
| Designation |
Post graduate |
| Affiliation |
Sibar Institute Of Dental Sciences |
| Address |
Department of Periodontics, Room no.8, second floor, Sibar Institute of Dental Sciences, Takkellapadu, Guntur
522509 Room no:8; Department of periodontics Guntur ANDHRA PRADESH 522509 India |
| Phone |
8500046546 |
| Fax |
|
| Email |
Sumanthbhimavarapu5@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Dhulipalla Ravindranath |
| Designation |
Professor and HOD |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Department of Periodontics, Room no.8, second floor, Sibar Institute of Dental Sciences, Takkellapadu, Guntur
522509
Guntur ANDHRA PRADESH 522509 India |
| Phone |
9849222259 |
| Fax |
|
| Email |
ravident69@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dhulipalla Ravindranath |
| Designation |
Professor and HOD |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Department of Periodontics, Room no.8, second floor, Sibar Institute of Dental Sciences, Takkellapadu, Guntur
522509
ANDHRA PRADESH 522506 India |
| Phone |
9849222259 |
| Fax |
|
| Email |
ravident69@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sibar institute of dental sciences, Department of Periodontics, Room no 8, Second floor, Takkellapadu Guntur, 522509 |
|
|
Primary Sponsor
|
| Name |
Sibar institute of dental sciences |
| Address |
Room no 8, Second floor, Sibar institute of dental sciences, Takkellapadu, Guntur, Andhra pradesh, India, 522509. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Bhimavarapu Sumanth |
Sibar institute of dental sciences |
Room no 8, 2nd floor, Sibar institute of dental sciences Takkellapadu, Guntur, 522509
Guntur
ANDHRA PRADESH Guntur ANDHRA PRADESH |
8500046546
Sumanthbhimavarapu5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sibar institute of dental sciences |
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 |
Injectable Platelet rich fibrin |
Platelet-rich fibrin (PRF), developed by Choukroun et al. enables getting a scaffold enriched with platelets and GFs, and leukocytes as well. The concentrate is generated from a blood harvest without any artificial biochemical modifications and anticoagulants. The previous researches have demonstrated that PRF contains greater number of GFs than PRP. It induces higher fibroblast migration and expression of a transforming growth factor-β, a platelet-derived growth factor, and a vascular endothelial growth factor. Since the standard PRF is not entirely appropriate for injection, a new injectable formulation of PRF enables easier use of platelet concentrate in a liquid state. Injectable PRF will be injected into the pocket until the material is detected at the gingival margin after scaling and root planing. 0.5 ml of PRF is placed into the pocket using syringe till it overflows. |
| Comparator Agent |
Ozonated olive oil gel |
Ozone is a naturally occurring gas created from three oxygen atoms. It is a powerful oxidizing agent with a high antimicrobial power against oral pathogens. The antibacterial action of ozone is related to its reacting capacity with lipid double bonds, thus leading to bacterial wall lysis and bacterial cell content extravasation. By entering the cell, ozone promotes oxidation of nucleic and amino acids; and cell lysis depends on the extent of these reactions. It also inactivates viruses by diffusing through the protein coat into the nucleic acid core, resulting in damage of the viral nucleic acid. The antimicrobial action of ozone is nonspecific and selective to microbial cells; it does not damage human body cells because of their major antioxidative ability. 0.5 ml of Ozonated Olive oil gel is placed into the pocket using syringe till it overflows. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Apparently Healthy individual.
Subjects with Stage-II periodontitis.
Subjects with bilateral apparently clinical conditions.
Subjects who are willing to give informed consent. |
|
| ExclusionCriteria |
| Details |
Pregnancy or lactating females.
Any form of tobacco usage.
History of systemic diseases.
Previous history of any periodontal treatment before 6 months. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Probing Pocket depth |
Baseline and 4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Plaque index
Gingival index
Clinical attachment level |
Baseline, 4 Weeks |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
21/10/2024 |
| 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="0" Months="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Chronic periodontitis is an inflammatory multifactorial disease resulting in destruction of the alveolar bone and connective tissues of the gingiva and periodontal ligament. The primary etiological agents, however, are the pathogenic bacteria that colonize the Dento-gingival interface leading to gingivitis (Loe et al, 1965). These bacteria further cause the formation of periodontal pockets by conversion of junctional and sulcular epithelium to pocket epithelium. Dental plaque consists of diverse community of micro-organisms which is found on the tooth surface as a biofilm consisting of numerous species, embedded in an extracellular matrix of polymers of host and microbial origin. Removal of both supragingival and subgingival plaque is necessary for effective periodontal therapy. The primary goal of periodontal treatment is the elimination or reduction in the number of pathogenic bacteria and inflammation, decrease in the probing pocket depth (PPD), and improvement in the clinical attachment level (CAL). Scaling and root planing (SRP) is the most common non-surgical periodontal treatment. However, variations in its efficacy to gain access into deep pockets, furcations or any other root morphologic alterations can leave residual plaque deposits in the pocket which can result in the recolonization of the treated areas with pathogenic organisms. Thus, use of adjunctive systemic and local anti-microbials in addition to SRP has been advocated to further reduce/eliminate micro-organisms count more specifically. Local antimicrobial therapy in periodontitis involves direct delivery of an antimicrobial agent(s) into subgingival sites, thereby reducing the systemic effect as compared to systemic therapy. Local delivery of antimicrobial agents can be in the form of mouth rinses, gels, chips, ointments, and pocket irrigation. Subgingival irrigation is the most widespread means of applying antimicrobials subgingivally whether professionally or by the patient. Platelets have been applied in dentistry for over the past three decades. These autologous regenerative tools are concentrated suspensions of supra physiological amount of growth factors and when applied locally, they can induce soft and hard tissue regeneration. The periodontal wound healing process implies a series of cell to cell interactions and molecular signals that are primarily mediated by cytokines and growth factors. Platelet-rich fibrin (PRF), developed by Choukroun et al. enables getting a scaffold enriched with platelets and GFs, and leukocytes as well. The concentrate is generated from a blood harvest without any artificial biochemical modifications and anticoagulants. The previous researches have demonstrated that PRF contains greater number of GFs than PRP. It induces higher fibroblast migration and expression of a transforming growth factor-β, a platelet-derived growth factor, and a vascular endothelial growth factor. Since the standard PRF is not entirely appropriate for injection, a new injectable formulation of PRF enables easier use of platelet concentrate in a liquid state. After being generated during centrifugation, it maintains its liquid viscosity for about 15 minutes. PRF has been developed at high centrifugation speeds enabling a formation of fibrin clot, which could be utilized as a three-dimensional scaffold for promotion of periodontal regeneration. Ozone is a naturally occurring gas created from three oxygen atoms. It is a powerful oxidizing agent with a high antimicrobial power against oral pathogens. The antibacterial action of ozone is related to its reacting capacity with lipid double bonds, thus leading to bacterial wall lysis and bacterial cell content extravasation. By entering the cell, ozone promotes oxidation of nucleic and amino acids; and cell lysis depends on the extent of these reactions. It also inactivates viruses by diffusing through the protein coat into the nucleic acid core, resulting in damage of the viral nucleic acid. The antimicrobial action of ozone is nonspecific and selective to microbial cells; it does not damage human body cells because of their major antioxidative ability. Recent researches have reported antimicrobial effects on oral pathogens of both gaseous and aqueous forms of ozone, and the effectiveness of ozone in the treatment of oral diseases is now a topic of deep research. Additional reports have indicated that aqueous ozone is extremely biocompatible with fibroblasts, cementoblasts, and epithelial cells, suggesting that aqueous ozone would be valuable in treating oral infectious diseases such as periodontal disease, apical periodontitis, and peri-implantitis. Ozone can be used in several forms for treatment of periodontal disease: Ozonated water, ozonated oil, and gaseous ozone. Nagayoshi et al. examined the effect of ozonated water on oral microorganisms and dental plaque and observed that ozonated water was effective for killing gram-positive and gram negative oral microorganisms and oral Candida Albicans. Dowad et al compared and evaluated the effects of oral irrigation of ozonated water, 0.2% Chlorhexidine and 10% povidine iodine on periodontal pathogens such as spirochetes and observed higher percentage of reduction in spirochetes with ozone water irrigation as to 0.2% chlorhexidine and 10% povidine iodine. Recent advances in the field of alternative medicine introduced various herbal products for the treatment of periodontitis. Local application of Curcumin, aloevera, olive oil, coconut oil etc are being used as adjunctives for periodontal therapy. Latest studies confirm that olive oil, being rich in oleic acid, can help prevent the formation of biofilm, which may, in turn, protect against dental caries and periodontitis. The aim of the present study is to evaluate the clinical efficacy of injectable platelet rich fibrin and ozonated olive oil as an adjunctive to non-surgical periodontal therapy in stage-II periodontitis. At the initial visit, a clinical examination will be performed on each patient and Clinical parameters such as plaque index, gingival index, pocket depth and clinical attachment level will be recorded. At Baseline all the patients will receive Non-surgical periodontal therapy which includes Supragingival scaling and thorough oral hygiene instructions are given. Subgingival Scaling and Root planning will be done in both groups (Group A and Group B) and injectable PRF will be injected into the pocket until the material is detected at the gingival margin in Group A and ozonated olive oil will be injected into the pocket until the material is detected at the gingival margin in Group B. Then periodontal dressing will be placed on treated site to ensure that gel will Stay long enough to be effective in the pocket. After a week periodontal dressing will be removed. Clinical parameters will be recorded 4 weeks after treatment. |