The Use of Flowable Resin Composite Stent in Reduction of Donor Site Morbidity After Free Gingival Graft Harvesting

Free Gingival Graft Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05779800
• Other study ID #: 9322
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: December 5, 2023

Study information

• Verified date: March 2023
• Source: Cairo University
• Contact: Mohamed E Temraz, bachelor
• Phone: 00201020117827
• Email: mohamed.temraz[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

After harvesting free gingival graft from the hard palate, Postoperative pain as well as bleeding are the most common complications.Different 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 graft.I: 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.

Description:

Intervention:

Flowable resin composite stent.

Procedure:

After the palatal sites be anaesthetized with 0.3 ml of a solution of 4% Articaine and 0.001% 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 5, 2023
• Est. primary completion date: November 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 62 Years

Eligibility

Inclusion Criteria:

• Patients with mucogingival defects scheduled for free gingival graft or de-epithelialized connective tissue graft.

• Systemically healthy

Exclusion Criteria:

• Smokers

• Occlusal trauma at site of graft

• Pregnancy and lactation

• Patients allergic to the used agents

• Severe gagging reflex

Related Conditions & MeSH terms

• Free Gingival Graft

Intervention

Device:
• Flowble resin composite stent
Flowble resin composite is a filling material used in operative dentistry and characterized by being flow and easily adapting the surfaces.
• periodontal pack
Non eugenol containing dressing supplied in two tubes

Locations

Country	Name	City	State
Egypt	Faculty of dentistry, Cairo univesity	Cairo	Manial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative pain	Pain score reported by the patient directly through Visual Analogue Scale score (between 0 and 100. 0: no pain, 10: minimal pain, 50:moderate pain, 100: severe pain)	on day 7
Secondary	Color match	The color of the palatal mucosa will be assessed by comparing it with that of the adjacent and opposite side by using the objective VAS (VAS score 0-10) represented by a continuous line, by a clinician blinded to the treatment group assignment.	On day 42
Secondary	wound size	To be recorded using (UNC 15) periodontal probe to the nearest measurement of 0.5 mm , length and width only	at day 21