Clinical trial NCT06060119: Comparison of Microneedling and CTG for Gingival Augmentation- A RCT
Official title: Comparison of Microneedling With Subepithelial Connective Tissue Auto Graft for Gingival Augmentation- A Randomized Case Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Gingival Phenotype
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SAMPLING TECHNIQUE Purposive Sampling technique will be done. All the patients meeting the criteria will be screened and then 12 patients will be randomly allotted into either of the two groups. The treatment allocation to the test and control group will be assigned by means of a sealed envelope containing a code derived from a computer generated randomized list to receive either -

1. TEST GROUP (n = 12) - Microneedling on the selected area.
2. CONTROL GROUP (n = 12) - Subepithelial connective tissue grafting at the contralateral site
Primary purpose: TREATMENT

Brief summary: The presence study is toComparison of Microneedling with Subepithelial Connective Tissue Auto Graft for Gingival Augmentation- A Randomized Case Control Trial. The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

Detailed description: The periodontal phenotype previously called as biotype is a reflection of gingiva and buccal bone thickness. It is a vital clinical parameter as it will determine whether there will be recession , dehiscence and fenestration or pocket formation.1Basically gingival epithelium provides a physical barrier to infection and protects the deeper structures thus, the gingival phenotype has major impact on the outcome of the restorative, regenerative, implant and orthodontic therapy.2 Common causes of recession are faulty toothbrushing ,tooth malposition, abnormal frenum attachment, trauma from occlusion and orthodontic tooth movement in labial direction.2 Gingiva can be classified as thick \> 1mm and thin \< 1mm according to recent 2017 world work shop classification.3 Traditionally, gingival augmentation is achieved using free gingival graft, connective tissue graft, soft tissue substitutes. Subepithelial connective tissue auto graft is still the gold standard. All of these technique's are invasive, complicated, technique senstive and do not have cost efficiency4, thus there is an on going reasearch for a more simpler non invasive method to increase gingival thickness.

Microneedling also knows as "percutaneous collagen induction therapy" is a novel and innovative method to thicken gingiva.5It involves creating several microinjuries in the form of inducing superficial bleeding points there by inducing a wound healing cascade which releases a few key soft tissue growth factor's such as platelet-derived growth factors, transforming growth factors, connective tissue growth factor and fibroblast growth factors.1 Fernandes has developed a percutaneous technology based on principals of microneedling to initiate natural post traumatic inflammatory reaction by using microneedles.6 The growthfactor's thus released post injury stimulate proliferation of new cells and transformation of fibroblast into collagen and elastin fiber, starting from 5th day up to 8th week. Newly formed fibers thicken the tissue during the process known as neocollagenesis. Fibroblasts also trigger neoangiogenesis by accelerating the proliferation of endothelial cells in the blood vessels. The tissue remodeling changes continue from 8 weeks up to 1 year.7 Thus, this non-invasive technique of microneedling will be compared to the time tested subepithelial connective tissue autograft to obtain a deeper insight over its feasibility.

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years of age.
* Patients with esthetic concern .
* Patient under going orthodontic, prosthodontic, restorative treatment where thick gingiva is necessary.
* Systemically healthy subjects
* Full mouth plaque index,full mouth bleeding on probing score \< or = 15
* Patient with palatal mucosa greater than 4mm

Exclusion Criteria:

* Previous periodontal surgery
* Patients with history of coagulation disorder
* Smoking habit
* Pregnant and lactating females
* Use of any

Primary outcomes:
measure: OBJECTIVES OF THE STUDY: The primary outcomes measured will be : 1) Increase in gingival augmentation with microneedling
timeFrame: 6 months
Secondary outcomes:
measure: thickness in mm
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: