Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05779800
Status:
RECRUITING
Last Update Posted:
2023-03-22
First Post:
2023-02-25
Brief Title:
The Use of Flowable Resin Composite Stent in Reduction of Donor Site Morbidity After Free Gingival Graft Harvesting
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Clinical Comparison of the Use of Flowable Resin Composite Stent Versus Periodontal Pack to Reduce Donor Site Morbidity After Free Gingival Graft Harvesting A Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-03
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:
After harvesting free gingival graft from the hard palate Postoperative pain as well as bleeding are the most common complicationsDifferent agents were used to protect the denuded areas on the palate as gelatin sponge Hyaluronic acid gel and platelet rich fibrin PRF but still no gold standard material is present
PICO format
P patients with mucogingival problems in need for free gingival graft or de-epithelialized connective tissue graftI Flowable resin composite stent C Periodontal pack O Post-operative pain T day 3 7 14 21 and 42 postoperative
Aim of the study
To compare the effect of flowable composite stent versus periodontal pack applied to palatal donor site after free gingival graft harvesting in terms of post-operative pain reduction
PICO format
P patients with mucogingival problems in need for free gingival graft or de-epithelialized connective tissue graftI Flowable resin composite stent C Periodontal pack O Post-operative pain T day 3 7 14 21 and 42 postoperative
Aim of the study
To compare the effect of flowable composite stent versus periodontal pack applied to palatal donor site after free gingival graft harvesting in terms of post-operative pain reduction
Detailed Description:
Intervention
Flowable resin composite stent
Procedure
After the palatal sites be anaesthetized with 03 ml of a solution of 4 Articaine and 0001 Adrenalin Graft harvesting will be performed by basic surgical techniques described by Miller 1982 A rectangular shaped piece of mucosa will be harvested from the area of the hard palate by a split-thickness dissection
The graft will then be used as it on the recipient bed The graft dimensions will be recorded width and length
Denuded palatal area will then be protected using one of the following options
1 Periodontal pack control group
2 flowble resin composite NEXOCOMP FLOW intervention group
Postoperative instructions
Postoperative instructions will include discontinuing tooth brushing and flossing around the surgical sites until the day of periodontal dressing removal day 7
Patients will be directed to consume only soft foods during the first week and to avoid any mechanical trauma
Patients will be scheduled to be seen on days 7 14 21 and 42 Periodontal pack and flowble resin composite stent will be first removed on day 7 and donor sites will be evaluated using selected parameters in both groups
Thereafter all patients will be followed up on days 14 21 and 42 for further evaluation
Flowable resin composite stent
Procedure
After the palatal sites be anaesthetized with 03 ml of a solution of 4 Articaine and 0001 Adrenalin Graft harvesting will be performed by basic surgical techniques described by Miller 1982 A rectangular shaped piece of mucosa will be harvested from the area of the hard palate by a split-thickness dissection
The graft will then be used as it on the recipient bed The graft dimensions will be recorded width and length
Denuded palatal area will then be protected using one of the following options
1 Periodontal pack control group
2 flowble resin composite NEXOCOMP FLOW intervention group
Postoperative instructions
Postoperative instructions will include discontinuing tooth brushing and flossing around the surgical sites until the day of periodontal dressing removal day 7
Patients will be directed to consume only soft foods during the first week and to avoid any mechanical trauma
Patients will be scheduled to be seen on days 7 14 21 and 42 Periodontal pack and flowble resin composite stent will be first removed on day 7 and donor sites will be evaluated using selected parameters in both groups
Thereafter all patients will be followed up on days 14 21 and 42 for further evaluation
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