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

NCT ID: NCT05779800

Last Updated: 2023-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2023-12-05

Brief Summary

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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

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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.

Conditions

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Free Gingival Graft

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Flowable resin composite stent group

Flowable resin composite is a bio compatible material used in dental field many years ago.

Group Type EXPERIMENTAL

Flowble resin composite stent

Intervention Type DEVICE

Flowble resin composite is a filling material used in operative dentistry and characterized by being flow and easily adapting the surfaces.

Periodontal pack group

Non eugenol containing periodontal pack used in periodontal surgeries to protect the wound.

Other name :COE\_PAK

Group Type ACTIVE_COMPARATOR

periodontal pack

Intervention Type DEVICE

Non eugenol containing dressing supplied in two tubes

Interventions

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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.

Intervention Type DEVICE

periodontal pack

Non eugenol containing dressing supplied in two tubes

Intervention Type DEVICE

Other Intervention Names

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NEXOCOMP FLOW COE-PAK

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

62 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Elsayed Ahmed Hassan Temraz

demonstrator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of dentistry, Cairo univesity

Cairo, Manial, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed E Temraz, bachelor

Role: CONTACT

00201020117827

Nesma M Shemais, PHD

Role: CONTACT

00201005615697

Facility Contacts

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Ahmed M Barbari, A.Professor

Role: primary

00201223153678

Faculty of dentistry, Cairo univesity

Role: backup

0020223642705

Other Identifiers

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9322

Identifier Type: -

Identifier Source: org_study_id

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