Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Gingival Recession
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 55 years
Gender
Both males and females

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 subepit...

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 CAF+CTG 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 days.28 For patients allergic to penicillin Clindamycin 300 mg 4 times daily for 5 days will be prescribed.29 A 60s rinse with 0.2% 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 month.3 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 procedure.18

Tracking Information

NCT #
NCT04692558
Collaborators
Not Provided
Investigators
Study Director: PRABHUJI MLV, MDS Krishnadevaraya College of Dental Sciences & Hospital