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Cyanoacrylate Tissue Adhesives Versus Silk Suture at the Palatal Donor Site of Sub Epithelial Connective Tissue Graft

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ClinicalTrials.gov Identifier: NCT04780360
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : March 8, 2021
Sponsor:
Information provided by (Responsible Party):
Mohamed Saeed Mohamed Ibrahuim Abdullah, Cairo University

Brief Summary:
Subepithelial connective tissue grafts (CTG) are considered the gold standard procedure with proven clinical success when it comes to gingival augmentation aims to to improve periodontal health, which can enhance the long-term prognosis of teeth by obtaining soft tissue coverage of exposed root surfaces and/or augmentation the dimensions of gingival tissue. The procedure require harvesting tissue from a the palate, which increases the complexity of the procedure and patient discomfort. Complications after harvesting a graft would be pain, inflammation, bleeding, flap necrosis and infection in the donor site.

Condition or disease Intervention/treatment Phase
The Effect of Local Aplication of Cayanoacrylate Tissue Adhesives on Improving the Healing Procedure: Cayanoacrylate tissue adhesives Procedure: Silk suture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluation of Post Operative Pain, Early Wound Healing, and the Time of Application of Cyanoacrylates Tissue Adhesives Versus Silk Sutures at the Palatal Donor Area of Subepithelial Connective Tissue Grafts (CTG) A Randomized Clinical Trial: Comparative Study
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Arm Intervention/treatment
Experimental: Cayanoacrylate tissue adhesives
thin layers of high viscosity blend of n-butyl and 2-octyl cayanoacrylate tissue adhesive will be applied and rinsed with saline at least three times with interval of at least 30 seconds
Procedure: Cayanoacrylate tissue adhesives
Cyanoacrylates are a family of strong fast-acting adhesives with industrial, medical, and household uses. They are various esters of cyanoacrylic acid. The acryl groups in the resin rapidly polymerize in the presence of water to form long, strong chains

Active Comparator: Silk suture material
interrupted knots
Procedure: Silk suture
Non Absorbalble suture materiel used to fixed the edges of the incision in place until healing




Primary Outcome Measures :
  1. Early Wound Healing [ Time Frame: 1 week ]
    Measured By Modified Early Wound Healing Index



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with mucogingival defects scheduled for sub epithelial connective tissue graft
  • Age at least 18 years.
  • Not having any systemic disease that could compromise wound healing
  • No periodontal surgery on the experimental sites.
  • No smoking,
  • No pregnancy or lactation

Exclusion Criteria:

  • Patients with coagulation disorders
  • patients on corticosteroids, with uncontrolled diabetes, or with any systemic disease that precluded periodontal surgery
  • patients with a history of contact dermatitis to formaldehyde
  • Loss of maxillary premolars and molars
  • Medications or antibiotics used in the previous 6 months
  • Pregnancy or lactation
  • Smoking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780360


Contacts
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Contact: Mohamed S Mohamed Ibrahium Abdullah, Invistegator 01283626196 ext 02 dr.mohamed15.ms@gmail.com

Locations
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Egypt
Faculty of Dentistry, Cairo Universty Recruiting
Cairo, Egypt, 0000
Contact: Hassan Ahmed, Adminstrator    23634965 ext 02    hassan.ahmed@dentistry.cu.edu.eg   
Sponsors and Collaborators
Cairo University
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Responsible Party: Mohamed Saeed Mohamed Ibrahuim Abdullah, Researcher, Cairo University
ClinicalTrials.gov Identifier: NCT04780360    
Other Study ID Numbers: 567
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 8, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No