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

NCT04780360 | Unknown

• 1 other identifier: 567
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

The Effect of Local Aplication of Cayanoacrylate Tissue Adhesives on Improving the Healing

Outcome Measures

Primary Outcomes (1)

• Early Wound Healing

  Measured By Modified Early Wound Healing Index

  1 week

Study Arms (2)

Cayanoacrylate tissue adhesives

EXPERIMENTAL

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

Silk suture material

ACTIVE COMPARATOR

interrupted knots

Procedure: Silk suture

Interventions

Cayanoacrylate tissue adhesives PROCEDURE

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

Cayanoacrylate tissue adhesives

Silk suture PROCEDURE

Non Absorbalble suture materiel used to fixed the edges of the incision in place until healing

Silk suture material

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo Universty

Cairo, 0000, Egypt

RECRUITING

Central Study Contacts

Mohamed S Mohamed Ibrahium Abdullah, Invistegator

CONTACT

01283626196; dr.mohamed15.ms@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: November 17, 2019
• First Posted: March 3, 2021
• Study Start: February 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 8, 2021

Record last verified: 2021-03

Locations

EG (1)