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

• Sponsor: Cairo University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05779800
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9.6
• Patients Per Site Per Month: 3.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Free Gingival Graft	Device: Flowble resin composite stent; Device: periodontal pack	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 15, 2023
• Anticipated Primary Completion Date: Nov 8, 2023
• Anticipated Study Completion Date: Dec 5, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Flowable resin composite stent group Flowable resin composite is a bio compatible material used in dental field many years ago.	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.; Other Names: NEXOCOMP FLOW
Active Comparator: Periodontal pack group Non eugenol containing periodontal pack used in periodontal surgeries to protect the wound. Other name :COE_PAK	Device: periodontal pack; Non eugenol containing dressing supplied in two tubes; Other Names: COE-PAK

Outcome Measures

Primary Outcome Measures

1. Post operative pain [on day 7]

   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)

Secondary Outcome Measures

1. Color match [On day 42]

   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.

2. wound size [at day 21]

   To be recorded using (UNC 15) periodontal probe to the nearest measurement of 0.5 mm , length and width only

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 62 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of dentistry, Cairo univesity	Cairo	Manial	Egypt	11

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed Elsayed Ahmed Hassan Temraz, demonstrator, Cairo University
• ClinicalTrials.gov Identifier: NCT05779800
• Other Study ID Numbers: 9322
• First Posted: Mar 22, 2023
• Last Update Posted: Mar 22, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mohamed Elsayed Ahmed Hassan Temraz, demonstrator, Cairo University: palatal donor site; Gingival Recession; Periodontal Diseases; Protective Agents; flowable composite

Study Results

No Results Posted as of Mar 22, 2023