Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04692558
Status:
UNKNOWN
Last Update Posted:
2021-01-05
First Post:
2019-12-13
Brief Title:
Effect of Hyaluronic Acid on Gingival Recession Treatment
Sponsor:
Krishnadevaraya College of Dental Sciences Hospital
Organization:
Krishnadevaraya College of Dental Sciences Hospital
Study Overview
Official Title:
Efficacy of Hyaluronic Acid on Connective Tissue Graft With Coronally Advanced Flap in the Treatment of Isolated Gingival Recession - A Randomized Controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
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:
Gingival marginal tissue recession is the displacement of the soft tissue margin apical to the cementoenamel junction CEJ with exposure of the root surface It is a common clinical finding in patients with high standards of oral hygiene and can be found in more than 90 of patients Buccal exposure of roots leading to esthetic concerns and dentinal hypersensitivity are the most frequent reasons for patients to seek treatment for the same
Gingival recession therapy is still challenging for clinicians The ultimate goal of root coverage procedures is the complete coverage of the recession defect with an esthetic appearance comparable to adjacent healthy soft tissues in combination with physiological probing pocket depths
Various treatment modalities have been put forth for the correction of gingival recession These include free gingival autograft subepithelial connective tissue graft SCTG coronally advanced flap CAF and various combinations Coronally advanced flap CAF in conjunction with the connective tissue graft CTG is considered the gold standard of treatment of gingival recession due to its high predictability of the treatment results
Several authors have explored the use of biological agents or like enamel matrix derivative EMD platelet-derived growth factor-BB PDGF fibroblast growth factor-2 FGF-2 which are a group of proteins capable of inducing gene or cell activation for cell recruitment matrix biosynthesis and cellular differentiation in an attempt to regenerate the lost periodontium to enhance its long term stability Hyaluronic acid HA is one such biologic agent that demonstrates future for periodontal regeneration It is a major component of the extracellular matrix in almost all tissues The primary role of HA is to bind water and to allow the transportation of key metabolites and therefore to maintain the structural and homeostatic integrity of these tissues HA suppresses tissue breakdown activating metalloproteinase inhibitors It represents one of the most hygroscopic molecules known in nature As a physical background material it functions as space filler lubricant and a protein excluder as well In vitro studies and animal studies have demonstrated that HA significantly increases the tensile strength of granulation tissue stimulates clot formation induces angiogenesis increases osteogenesis and does not interfere in the calcification nodules during bone formation Furthermore HA facilitates cell migration and differentiation during tissue formation and repair of both soft and hard tissues It improves ligament cell viability and early osteogenic differentiation
Considering the fact that HA has positive effects on wound healing we hypothesized that it may also improve the results of root coverage by CAFCTG Therefore the aim of this randomized controlled clinical trial RCT will be to evaluate the potential benefit of the adjunctive use of HA in combination with CAFCTG and to compare the outcomes with CAFCTG alone when treating single Miller class I and class IIRT1gingival recessions
Gingival recession therapy is still challenging for clinicians The ultimate goal of root coverage procedures is the complete coverage of the recession defect with an esthetic appearance comparable to adjacent healthy soft tissues in combination with physiological probing pocket depths
Various treatment modalities have been put forth for the correction of gingival recession These include free gingival autograft subepithelial connective tissue graft SCTG coronally advanced flap CAF and various combinations Coronally advanced flap CAF in conjunction with the connective tissue graft CTG is considered the gold standard of treatment of gingival recession due to its high predictability of the treatment results
Several authors have explored the use of biological agents or like enamel matrix derivative EMD platelet-derived growth factor-BB PDGF fibroblast growth factor-2 FGF-2 which are a group of proteins capable of inducing gene or cell activation for cell recruitment matrix biosynthesis and cellular differentiation in an attempt to regenerate the lost periodontium to enhance its long term stability Hyaluronic acid HA is one such biologic agent that demonstrates future for periodontal regeneration It is a major component of the extracellular matrix in almost all tissues The primary role of HA is to bind water and to allow the transportation of key metabolites and therefore to maintain the structural and homeostatic integrity of these tissues HA suppresses tissue breakdown activating metalloproteinase inhibitors It represents one of the most hygroscopic molecules known in nature As a physical background material it functions as space filler lubricant and a protein excluder as well In vitro studies and animal studies have demonstrated that HA significantly increases the tensile strength of granulation tissue stimulates clot formation induces angiogenesis increases osteogenesis and does not interfere in the calcification nodules during bone formation Furthermore HA facilitates cell migration and differentiation during tissue formation and repair of both soft and hard tissues It improves ligament cell viability and early osteogenic differentiation
Considering the fact that HA has positive effects on wound healing we hypothesized that it may also improve the results of root coverage by CAFCTG Therefore the aim of this randomized controlled clinical trial RCT will be to evaluate the potential benefit of the adjunctive use of HA in combination with CAFCTG and to compare the outcomes with CAFCTG alone when treating single Miller class I and class IIRT1gingival recessions
Detailed Description:
After administration of local anesthesia
Two oblique and divergent releasing incisions extending beyond the mucogingival junction MGJ will be performed An intra-sulcular incision was performed at the buccal aspect of the involved tooth
A second surgical site will be prepared to obtain the subepithelial CTG using single incision technique as described by Hurzeler and Weng
For the control group only CAFCTG will be performed For the test group cross-linked HA will be applied over the exposed root surface before the placement of CTG and CAF closure HA will be presented as individual cartridge for single use only For the application on the denuded root surface the cartridge will be inserted into a cartridge syringe with 23G needles as the fabricant recommended HA will be applied on the root surface until completely covered the harvested CTG will be placed and stabilized with sutures Finally the flap will be coronally displaced and sutured covering the CEJ Interrupted sutures will be placed at the vertical releasing incisions in apical-coronal direction to reduce the tension and to facilitate the coronal displacement to perform the last coronal sling suture
Post-operative pain and edema will be controlled with anti-inflammatory drugs Patients received Ibuprofen 400 mg thrice daily for 3 days19 and Amoxicillin 500mg thrice daily for 5 days28 For patients allergic to penicillin Clindamycin 300 mg 4 times daily for 5 days will be prescribed29
A 60s rinse with 02 chlorhexidine gluconate was prescribed two times per day for the first 2 weeks
All participants will be instructed to intermittently apply an ice bag on the operated area
Participants will be recalled after a period of 14 days for suture removal After this period patients will be reinstructed in mechanical cleaning of the treated teeth and use of a soft toothbrush and roll technique of brushing for one month3
Participants will be recalled for reinforcement of oral hygiene instructions and light debridement supragingivally will be carried out Clinical parameters will be recorded at 6 weeks 3 months and 6 months after surgical procedure18
Two oblique and divergent releasing incisions extending beyond the mucogingival junction MGJ will be performed An intra-sulcular incision was performed at the buccal aspect of the involved tooth
A second surgical site will be prepared to obtain the subepithelial CTG using single incision technique as described by Hurzeler and Weng
For the control group only CAFCTG will be performed For the test group cross-linked HA will be applied over the exposed root surface before the placement of CTG and CAF closure HA will be presented as individual cartridge for single use only For the application on the denuded root surface the cartridge will be inserted into a cartridge syringe with 23G needles as the fabricant recommended HA will be applied on the root surface until completely covered the harvested CTG will be placed and stabilized with sutures Finally the flap will be coronally displaced and sutured covering the CEJ Interrupted sutures will be placed at the vertical releasing incisions in apical-coronal direction to reduce the tension and to facilitate the coronal displacement to perform the last coronal sling suture
Post-operative pain and edema will be controlled with anti-inflammatory drugs Patients received Ibuprofen 400 mg thrice daily for 3 days19 and Amoxicillin 500mg thrice daily for 5 days28 For patients allergic to penicillin Clindamycin 300 mg 4 times daily for 5 days will be prescribed29
A 60s rinse with 02 chlorhexidine gluconate was prescribed two times per day for the first 2 weeks
All participants will be instructed to intermittently apply an ice bag on the operated area
Participants will be recalled after a period of 14 days for suture removal After this period patients will be reinstructed in mechanical cleaning of the treated teeth and use of a soft toothbrush and roll technique of brushing for one month3
Participants will be recalled for reinforcement of oral hygiene instructions and light debridement supragingivally will be carried out Clinical parameters will be recorded at 6 weeks 3 months and 6 months after surgical procedure18
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