Cyanoacrylate With Sutures for Fixation of Free Gingival Graft
Primary Purpose
Soft Tissue Atrophy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cyanoacrylate tissue adhesive beside sutures
Sponsored by
About this trial
This is an interventional supportive care trial for Soft Tissue Atrophy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cyanoacrylate beside sutures for FGG fixation
Arm Description
butyl cyanoacrylate
Outcomes
Primary Outcome Measures
graft shrinkage in millimeter
graft area ,thickness in millimeter
Secondary Outcome Measures
success percentage
% percentage (success of Free Gingival Graft Fixation)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04063475
Brief Title
Cyanoacrylate With Sutures for Fixation of Free Gingival Graft
Official Title
Cyanoacrylate Tissue Adhesive Assisted Soft Tissue Stabilization: a Novel Technique for Free Gingival Graft Fixation (Case Series Study)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 16, 2019 (Anticipated)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
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
5. Study Description
Brief Summary
fixation of FGG with sutures alone is not sufficient,we use cyanoacrylate beside sutures for fixation
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Atrophy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cyanoacrylate beside sutures for Fixation of FGG
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cyanoacrylate beside sutures for FGG fixation
Arm Type
Experimental
Arm Description
butyl cyanoacrylate
Intervention Type
Drug
Intervention Name(s)
cyanoacrylate tissue adhesive beside sutures
Other Intervention Name(s)
tissue adhesive
Intervention Description
using cyanoacrylate tissue adhesive for FGG fixation
Primary Outcome Measure Information:
Title
graft shrinkage in millimeter
Description
graft area ,thickness in millimeter
Time Frame
2 weeks,month,3months
Secondary Outcome Measure Information:
Title
success percentage
Description
% percentage (success of Free Gingival Graft Fixation)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cyanoacrylate With Sutures for Fixation of Free Gingival Graft
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