Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05869136
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2023-05-11
Brief Title:
Evaluation Of Microneedling Alone vs Microneedling Along With Hyaluronic Acid In Thin Gingival Phenotype
Sponsor:
Postgraduate Institute of Dental Sciences Rohtak
Organization:
Postgraduate Institute of Dental Sciences Rohtak
Study Overview
Official Title:
Comparative Evaluation Of Microneedling Alone vs Microneedling Along With Hyaluronic Acid In Thin Gingival Phenotype A Split Mouth Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The periodontal phenotype has been defined as the combination of gingival phenotype and buccal bone plate thickness bone morphotypePeriodontal phenotype cannot be fully assessed but gingival phenotype can be evaluated through a standard and reproducible way
Gingival recession is usually observed in the presence of trauma and inflammation in individuals with thin phenotypes whereas pocket formation has been reported in individuals with thick phenotypes
Various soft tissue augmentation procedures include sub-epithelial connective tissue graft free gingival graft modified roll technique and use of acellular dermal matrix The drawbacks of these techniques include second surgical site creation post-operative discomfort time consuming procedure etc
Recent studies have shown i-PRF microneedeling and hyaluronic acid procedures to be effective in increasing gingival tissue thickness
HA has been widely used in the dental field specially periodontology due to its bacteriostatic fungistatic anti-inflammatory anti-edematous osteoinductive and pro-angiogenetic properties HAs role in tissue regeneration and wound healing has gained huge interest in recent studies
Microneedling MN is also known as percutaneous collagen induction therapy Microinjuries created by MN result in minimal superficial bleedings and create a wound-healing cascade from which various growth factors such as platelet-derived growth factors transforming growth factors connective tissue growth factor and fibroblast growth factors are releasedStudy has shown a statistically significant increase in gingival thickness when microneedling was performed along with i-PRF in comparison to standalone i-PRF
Few human trials have been conducted using MN and Hyaluronic acids in literature for gingival augmentation in thin periodontal phenotype Considering the effects of MN and hyaluronic acid on the biological potential neoangiogenesis neocollagenesis and wound the present Randomized clinical trial is designed to evaluate the effects of MN alone and MN along with hyaluronic acid in thin gingival phenotype
Gingival recession is usually observed in the presence of trauma and inflammation in individuals with thin phenotypes whereas pocket formation has been reported in individuals with thick phenotypes
Various soft tissue augmentation procedures include sub-epithelial connective tissue graft free gingival graft modified roll technique and use of acellular dermal matrix The drawbacks of these techniques include second surgical site creation post-operative discomfort time consuming procedure etc
Recent studies have shown i-PRF microneedeling and hyaluronic acid procedures to be effective in increasing gingival tissue thickness
HA has been widely used in the dental field specially periodontology due to its bacteriostatic fungistatic anti-inflammatory anti-edematous osteoinductive and pro-angiogenetic properties HAs role in tissue regeneration and wound healing has gained huge interest in recent studies
Microneedling MN is also known as percutaneous collagen induction therapy Microinjuries created by MN result in minimal superficial bleedings and create a wound-healing cascade from which various growth factors such as platelet-derived growth factors transforming growth factors connective tissue growth factor and fibroblast growth factors are releasedStudy has shown a statistically significant increase in gingival thickness when microneedling was performed along with i-PRF in comparison to standalone i-PRF
Few human trials have been conducted using MN and Hyaluronic acids in literature for gingival augmentation in thin periodontal phenotype Considering the effects of MN and hyaluronic acid on the biological potential neoangiogenesis neocollagenesis and wound the present Randomized clinical trial is designed to evaluate the effects of MN alone and MN along with hyaluronic acid in thin gingival phenotype
Detailed Description:
Gingival phenotype refers to gingival thickness GT and keratinized tissue width KTW
Gingival phenotypes can be classified as scalloped and thin or flat and thick gingiva Thin gingival phenotype are very friable and might be prone to recede in response to traumatic insults such as plaque-related inflammation and traumatic toothbrushing Studies have believed that HA accelerates the wound healing process and promotes regeneration as it maintains the viability of oral fibroblasts increases their proliferative and migratory abilities and enhances the expression of genes encoding type III collagen and transforming growth factor-β Study has shown a statistically significant increase in gingival thickness when microneedling was performed along with i-PRF in comparison to standalone i-PRF
Given these characteristicsthis study will be conducted to comparative evaluation of microneedling alone and along with hyaluronic acid on thin gingival phenotype
The present randomized controlled clinical trial will be conducted in the department of periodontics and oral implantologyPost Graduate Institute of Dental SciencesRohtakStudy design is of 24 months
Total 20 patients will be recruited on the basis of inclusion and exclusion criteria with thin periodontal phenotypes who had consulted to the Department of Periodontology Post Graduate Institute of Dental Sciences Rohtak
20 systematically healthy patients having thin gingival phenotypes will be included in this split-mouth randomized controlled trial For each patient each side of the anterior mandible will be randomly allocated to one of the two procedures MN or MN with Hyaluronic acidusing chit system In the MN group microneedling will be done 1 mm below the gingival margin with 30-gauze lancet needles In the HA with MN group the selected sites of the gingiva will injected with cross-linked HA using a 30-gauge microneedle followed by microneedling This described procedure will be repeated in both groups three times with intervals of 10 days The GT KTW and periodontal indices gingival index GI bleeding on probing BOP and probing depth PD will be measured at baseline 1 month 6 months and 9 months
Gingival phenotypes can be classified as scalloped and thin or flat and thick gingiva Thin gingival phenotype are very friable and might be prone to recede in response to traumatic insults such as plaque-related inflammation and traumatic toothbrushing Studies have believed that HA accelerates the wound healing process and promotes regeneration as it maintains the viability of oral fibroblasts increases their proliferative and migratory abilities and enhances the expression of genes encoding type III collagen and transforming growth factor-β Study has shown a statistically significant increase in gingival thickness when microneedling was performed along with i-PRF in comparison to standalone i-PRF
Given these characteristicsthis study will be conducted to comparative evaluation of microneedling alone and along with hyaluronic acid on thin gingival phenotype
The present randomized controlled clinical trial will be conducted in the department of periodontics and oral implantologyPost Graduate Institute of Dental SciencesRohtakStudy design is of 24 months
Total 20 patients will be recruited on the basis of inclusion and exclusion criteria with thin periodontal phenotypes who had consulted to the Department of Periodontology Post Graduate Institute of Dental Sciences Rohtak
20 systematically healthy patients having thin gingival phenotypes will be included in this split-mouth randomized controlled trial For each patient each side of the anterior mandible will be randomly allocated to one of the two procedures MN or MN with Hyaluronic acidusing chit system In the MN group microneedling will be done 1 mm below the gingival margin with 30-gauze lancet needles In the HA with MN group the selected sites of the gingiva will injected with cross-linked HA using a 30-gauge microneedle followed by microneedling This described procedure will be repeated in both groups three times with intervals of 10 days The GT KTW and periodontal indices gingival index GI bleeding on probing BOP and probing depth PD will be measured at baseline 1 month 6 months and 9 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None