Cyanoacrylate With Sutures for Fixation of Free Gingival Graft

Cyanoacrylate Tissue Adhesive Assisted Soft Tissue Stabilization: a Novel Technique for Free Gingival Graft Fixation (Case Series Study)

fixation of FGG with sutures alone is not sufficient,we use cyanoacrylate beside sutures for fixation

Study Overview

• Status: Unknown
• Conditions: Soft Tissue Atrophy
• Intervention / Treatment: Drug: cyanoacrylate tissue adhesive beside sutures

Detailed Description

Inadequate zone of attached mucosa around implants, gingival recession, inadequate ridge width or height despite there is enouph bone for implant placement are problems that face periodontists and can be treated by soft tissue graft Studies have demonstrated the importance of the tissues stability for the first hours when support is provided by underlying osseous or dental structures.

Movement of the graft during mastication and phonation will disturb healing procedures. Most of the clinicians prefer a protective device during the healing phase.

Transitional dentures are not stable themselves, and hence are not suitable for stabilizing.

Circummandibular wiring and impact posts are seemingly very aggressive for patients and need extra clinical practices, skills, and equipment.

Studies proved that the maximum tissue shrinkage (approximately 20%-40%) occurs during the first 3 months post operation and will proceed until 12 postsurgical months with a persistent, significantly lower rate.

In this study we give more stabilization for free gingival grafts by using cyanoacrylate tissue adhesive beside sutures Its autogenous character, maintenance of keratinization, predictability, ease of technique tlead CTG to be accepted as the golden standard to increase attached gingival dimensions Cyanoacrylate is a simple, inexpensive haemostatic and biocompatible material It is used as tissue adhesives in paediatric surgery general surgery and also dentistry.

it has been applied intraorally with different purposes such as periodontal dressing,for sealing sinus membrane perforations for stabilizing bone fragments during fracture fixation, and in closing peripheral nerve anastomosis it seems promising in the intraoral field due to their strong sealing, bacteriostatic, and hemostatic properties. Multiple studies examined the use of cyanoacrylate glues as an alternative to suturing intraoral and extraoral wounds concluding that cyanoacrylates are faster, more reliable ,and less painful and cause better hemostasis .

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with hopeless teeth that need extraction
• Age: between 20 and 60 years
• Both sexes.
• Subjects willing to sign an informed consent form ,participate in the study and return for follow-up visits

Exclusion Criteria:

• • Patients with coagulation disorders (Hemophilia a/b, von Willebrand disease, liver disease, anticoagulative therapy),

  • patients on corticosteroids,
  • patients with uncontrolled diabetes mellitus
  • smokers
  • Pregnant or lactating mother.
  • Known systemic diseases and/ or drug therapy which may interfere with wound healing or contraindicate periodontal therapy
  • Allergy to cyanoacrylate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: cyanoacrylate beside sutures for FGG fixation; butyl cyanoacrylate	Drug: cyanoacrylate tissue adhesive beside sutures; using cyanoacrylate tissue adhesive for FGG fixation; Other Names: tissue adhesive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
graft shrinkage in millimeter	graft area ,thickness in millimeter	2 weeks,month,3months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success percentage	% percentage (success of Free Gingival Graft Fixation)	3 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 16, 2019
• Primary Completion (ANTICIPATED): June 1, 2020
• Study Completion (ANTICIPATED): June 1, 2020

Study Registration Dates

• First Submitted: June 16, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (ACTUAL): August 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: cyanoacrylate in FGG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No