Clinical trial NCT05779800: The Use of Flowable Resin Composite Stent in Reduction of Donor Site Morbidity After Free Gingival Graft Harvesting
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Free Gingival Graft
Keywords: palatal donor site
Gingival Recession
Periodontal Diseases
Protective Agents
flowable composite
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 34
Sex: ALL
Minimum age (years): 21
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post operative pain
timeFrame: on day 7
Secondary outcomes:
measure: Color match
timeFrame: On day 42
measure: wound size
timeFrame: at day 21
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry, Cairo univesity
state: Manial
Study officials:
References: