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临床试验/CTRI/2024/04/065645
CTRI/2024/04/065645尚未招募2/3 期

Comparative evaluation of efficacy of photobiomodulation, injectable platelet rich fibrin and optimized diet, adjunct to microneedling in enhancing gingival biotype- A clinical study.

Sharavathi Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年4月20日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
1. Plaque index(Silness and Loe 1964)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • Patients who have undergone periodontal treatment less than six months before the study.
  • Patients allergic to Flax seeds (Linum Usitatisimum) or gooseberry (Phyllanthus emblica).
  • Patients with severe malocclusion or those undergoing active orthodontic therapy.
  • Smokers and tobacco chewers.
  • Patients with systemic diseases.

结局指标

主要结局

1. Plaque index(Silness and Loe 1964)

时间窗: BASELINE | 3 MONTHS | 6 MONTHS

2. Gingival index(Loe and Silness 1963)

时间窗: BASELINE | 3 MONTHS | 6 MONTHS

3. Probing pocket depth recorded using UNC15 probe.

时间窗: BASELINE | 3 MONTHS | 6 MONTHS

4. Keratinized tissue width

时间窗: BASELINE | 3 MONTHS | 6 MONTHS

5. Free gingival margin location.

时间窗: BASELINE | 3 MONTHS | 6 MONTHS

6.Transgingival probing

时间窗: BASELINE | 3 MONTHS | 6 MONTHS

7. Thickness of gingiva

时间窗: BASELINE | 3 MONTHS | 6 MONTHS

次要结局

  • Biotype thickness(Patient centered outcome results)

研究者

发起方
Sharavathi Dental College and Hospital
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Angel Srujana Moogala

Sharavathi Dental College and Hospital

研究点 (1)

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