| CTRI Number |
CTRI/2024/04/065645 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive Other (Specify) [non surgical] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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To compare and evaluate treatment procedures of photobiomodulation therapy, injectable PRF and optimized diet to enhance gingival biotype.
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Scientific Title of Study
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Comparative evaluation of efficacy of photobiomodulation, injectable platelet rich fibrin and optimized diet, adjunct to microneedling in enhancing gingival biotype- A clinical study.
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| Trial Acronym |
NIL |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Angel Srujana Moogala |
| Designation |
Postgraduate |
| Affiliation |
Sharavathi Dental College and Hospital |
| Address |
Department of periodontology,room number 7,Sharavathi Dental college and hospital, Shimoga, Karnataka
Shimoga KARNATAKA 577205 India |
| Phone |
9912409416 |
| Fax |
|
| Email |
angelsrujan@gmail.com |
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Details of Contact Person Scientific Query
|
| Name |
Dr Shrinidhi MS |
| Designation |
Professor and HOD |
| Affiliation |
Sharavathi Dental College and Hospital |
| Address |
Department of periodontology,
room number 7,
Sharavathi dental college and hospital, Shimoga, Karnataka
Shimoga KARNATAKA -577205 India |
| Phone |
9912409416 |
| Fax |
|
| Email |
shrinidhims75@gmail.com |
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Details of Contact Person Public Query
|
| Name |
Dr Angel Srujana Moogala |
| Designation |
Postgraduate |
| Affiliation |
Sharavathi Dental College and Hospital |
| Address |
Department of periodontology,
room number 7,Sharavathi Dental college and hospital, Shimoga, Karnataka
Shimoga KARNATAKA 577205 India |
| Phone |
9912409416 |
| Fax |
|
| Email |
angelsrujan@gmail.com |
|
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Source of Monetary or Material Support
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| Department of periodontology,
Sharavathi Dental College and Hospital, Shimoga, Karnataka |
|
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Primary Sponsor
|
| Name |
Sharavathi Dental College and Hospital |
| Address |
Department of Periodontology,
Room number 7, Sharavathi Dental College and Hospital, Shimoga
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| Type of Sponsor |
Research institution |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Angel Srujana Moogala |
Sharavathi Dental College and Hospital, Shimoga |
Department of periodontology
Room Number 7
Sharavathi Dental College and Hospital Shimoga Shimoga KARNATAKA |
9912409416
angelsrujan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHARAVATHI ETHICS COMMITTEE |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Healthy Human Volunteers |
healthy patients with thin gingival biotype |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
iPRF adjunct to microneedling |
Thirty patients are treated by injecting i-PRF into the attached gingiva adjunct to microneedling,i-PRF is prepared using 10 ml of patient blood and centrifuging for 3 min, and then injected into the attached gingiva using a syringe. for four sessions with a time interval of ten days. |
| Comparator Agent |
Optimized diet adjunct to microneedling |
Thirty patients are provided with optimized dietary supplements, which includes flax seeds (Linum Usitatisimum) powder, 5 grams and gooseberry (Phyllanthus emblica) powder, 5 grams are delivered in sachets, for a time interval of one month after consultation with a dietician adjunct to microneedling, for four sessions with duration of ten days interval.
|
| Intervention |
Photobiomodulation therapy adjunct to
microneedling |
Thirty patients with thin gingiva are chosen to enhance gingival thickness, photobiomodulation therapy adjunct to microneedling is conducted to enhance thin gingiva. A diode laser of 660nm is used for 60 seconds, 6J at 100 watt is used in the maxillary anterior gingival region for the patients with thin gingival biotype. Treatment is conducted in 4 sessions with a duration of alternate day interval. Primary and secondary outcomes involving clinical parameters and thickness of gingiva are calculated at baseline, 3 months and 6 months |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy individuals of different age groups ranging from 18 years to 30 years.
2.Patients presenting with thin gingival biotype maxillary anteriors.
3.Patients with good periodontal health and oral hygiene without bone loss or gingival inflammation.
4.No history of dental or traumatic lesion.
5.Patients having adequate keratinized tissue width.
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| ExclusionCriteria |
| Details |
. Patients who have undergone periodontal treatment less than six months before the study.
2. Patients allergic to Flax seeds (Linum Usitatisimum) or gooseberry (Phyllanthus emblica).
3. Patients with severe malocclusion or those undergoing active orthodontic therapy.
4. Smokers and tobacco chewers.
5. Patients with systemic diseases.
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Method of Generating Random Sequence
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Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Participant Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
1. Plaque index(Silness and Loe 1964)
2. Gingival index(Loe and Silness 1963)
3. Probing pocket depth recorded using UNC15 probe.
4. Keratinized tissue width
5. Free gingival margin location.
6.Transgingival probing
7. Thickness of gingiva
|
BASELINE
3 MONTHS
6 MONTHS |
|
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Secondary Outcome
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| Outcome |
TimePoints |
Biotype thickness
Patient centered outcome results
VAS |
Baseline
3 months
6 months |
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Target Sample Size
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Total Sample Size="90" Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 2/ Phase 3 |
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Date of First Enrollment (India)
|
20/04/2024 |
| 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 |
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Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [angelsrujan@gmail.com].
- For how long will this data be available start date provided 07-04-2024 and end date provided 07-04-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
| NEED FOR THE STUDY: Gingival biotype is described as the thickness of the gingiva in the faciopalatal/ faciolingual dimension. It is one of the important parameters that influences the outcome of the periodontal procedures. The prognosis of orthodontic procedures, crown lengthening, gingival contouring and implant prosthesis significantly depend on the gingival biotype for its value added esthetics. Several factors that contribute to the gingival health include the dimension of the alveolar process, the morphology of the tooth structure, inclination and tooth position in the arch, presence of trauma and inflammation. Compromised gingival thickness acts as an aggravating factor for periodontal attachment loss and marginal tissue recession. Ochsenbien and Ross (1969) described gingival biotype as scalloped and thin or flat and thick gingiva. A gingival thickness of ⩾2 mm was considered as a thick tissue biotype and a gingival thickness of <1.5 mm is referred to as thin tissue biotype. The thick gingival biotype due to its adequate vascularity enhances healing after regenerative procedures compared to thin biotype which might compromise it. Thick gingival tissues are more resistant to mucosal recession and mechanical irritation by maintaining its contours and marginal tissue integrity. Hence, a thick biotype is preferred over a thin biotype. A thin biotype can be treated by various modalities like soft tissue augmentation procedures such as subepithelial connective tissue grafting, acellular dermal matrix, injecting platelet rich fibrin. However, no single procedure has been identified as the gold standard till date. Macro and micronutrients in the diet have been found to have a profound effect on periodontium in terms of healing, repair, altering the plaque formation, enhancing the tissue resistance and altering the oxidative stress in the tissues. The omega-3 polyunsaturated fatty acids (PUFA) reduce tissue inflammation by generating bioactive lipid mediators. Flax seeds (Linum Usitatisimum) are a rich source of omega-3 fatty acid, dietary fibre, high quality of proteins and anti-oxidants. In addition the antimicrobial properties of flax seeds have synergistic action by decreasing inflammation and bone loss. Further, omega-3 fatty acid have positive effect on wound healing exhibiting reduction in clinical attachment loss and pocket depth. Similarly Vitamin C also has an essential role in collagen synthesis and immune function in addition to stimulation of periodontal progenitor cells. Therefore, it can be inferred that the benefits of intake of a collagen promoting diet include modifying thin tissue biotype into thick gingival biotype thereby increasing the resistance to infection or recession. An innovative and less invasive approach to increase gingival biotype is by microneedling or injecting injectable platelet rich fibrin (i-PRF) into the gingival tissues. Microneedling is often referred to as percutaneous collagen induction therapy. Micro injuries created on the gingiva result in release of various growth factors collagen, triggering fibroblast mediated repair thereby remodeling the tissues. Injectable platelet rich fibrin enables slow and sustained release of growth factors and have a positive influence in increasing gingival thickness by promoting collegen-1 synthesis. It accelerates the wound healing process with increased tissue vascularization. In periodontal procedures i-PRF was found to be effective in tissue and bone regeneration. Hence, i-PRF and micro needling are preferred as a nonsurgical periodontal treatment modality in modifying thin gingival biotype. Photobiomodulation therapy (PBMT) which was previously known as Low level Laser therapy, improves soft tissue healing and has a wide range of anti-inflammatory, analgesic and regenerative properties. It causes neuropharmacological effects, resulting in either production or inhibition of several biochemical substances. In addition it also accelerates tissue re-epithelization by upregulating the collagen synthesis, angiogenesis and by releasing growth factors.12 Photobiomodulation as an adjunct to microneedling can achieve faster and optimal wound healing. However, literature that correlates the effect of diet or photobiomodulation on the improvement of gingival biotype is scanty. Hence, a comparative study is intended to assess the role of optimized diet in comparison to i-PRF and PBMT in improving the gingival thickness. | AIM AND OBJECTIVES OF THE STUDY: 1. To evaluate and measure the changes in the gingival biotype in patients on optimized diet, after microneedling. 2. To evaluate and measure the changes in the gingival biotype on injecting i-PRF after microneedling. 3. To evaluate and measure the changes in the gingival biotype on photobiomodulation after microneedling. 4. To comparatively evaluate and assess the changes in the gingival biotype after intake of adequate optimized diet, photobiomodulation and treating with i-PRF. Methodology:
- Source of Data: Outpatient department attendees aged 18-30 with thin gingival biotype.
- Sampling Method: Non-randomized clinical trial with 90 participants.
- Group Allocation:
- Group I: Optimized diet (flax seeds and gooseberry) with microneedling.
- Group II: i-PRF injection with microneedling.
- Group III: PBMT with microneedling.
- Data Collection:
- Baseline parameters: Demographics, plaque index, gingival index, probing pocket depth, keratinized tissue width, free gingival margin location, transgingival probing and gingival thickness.
- Clinical measurements recorded at baseline and after three months.
- Statistical Analysis: Descriptive statistics, independent T-test/Mann-Whitney U test, SPSS version 23.
- CONCLUSION:
- This study aims to compare the effectiveness of an optimized diet, i-PRF, and PBMT in modifying thin gingival biotype. The findings could contribute valuable insights to periodontal care and guide clinical practices in enhancing gingival health.
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