Clinical trial

Multicenter Randomized Clinical Trial of the Use of Cyanoacrylate in Healing and Pain in the Palatal Donor Site of Connective Tissue Grafts

Name
cyanoacrylate multicenter
Description
Periodontal plastic surgery has been performed successfully for a long time in the treatment of gingival recessions and mucogingival defects. Epithelial and connective tissue grafts are considered the "gold standard" treatment for gingival recession due to their biocompatibility and long-term stability, however they require tissue harvesting from a donor area, usually the palate, increasing patient discomfort. Various hemostatic and healing agents have been used in conjunction with suturing to speed healing and reduce complications associated with this procedure, such as bleeding and pain. These include absorbable synthetic collagen, absorbable gelatin sponges, oxidized regenerated cellulose, ferric subsulfate, and more recently, cyanoacrylate cements and platelet-rich fibrin. Cyanoacrylate adhesives are synthesized as monomers by condensation of a cyanoacetate with formaldehyde in the presence of catalysts and the adhesive film is developed by rapid polymerization caused by hydroxide groups to the surfaces to be adhered. The properties of cyanoacrylate tissue adhesives of greatest interest in the surgical field are excellent hemostasis, rapid tissue adhesion, and possible bacteriostatic qualities.
Trial arms
Trial start
2024-01-01
Estimated PCD
2024-03-01
Trial end
2024-05-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Cyanoacrylate
In the test group, a cyanoacrylate-based tissue adhesive (PeriAcryl 90 HV; Glustitch, Delta, Canada) will be applied.
Arms:
Cyanoacrylate Group
Suture
After harvesting the full-thickness connective tissue graft, the edges of the control group will be approximated with 4/0 non-absorbable monofilament nylon suture (Aragó, Barcelona, Spain).
Arms:
Suture Group
Size
80
Primary endpoint
Pain perception
Days 1,2,3,4,5,6,7 and 14 after the procedure
Eligibility criteria
Inclusion Criteria: * The patient must be considered a candidate for mucogingival treatment * Requiring grafting around teeth or implants. * No age limit is established for the sample. Exclusion Criteria: * Patients with systemic or scarring compromises * Treated with bisphosphonates * Smokers of more than 10 cigarettes a day * With a history of previous palatal grafting in that location * Present any type of contraindication to undergo surgery cannot take part in the study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2023-11-03

1 organization

1 product

3 indications

Indication
Pain
Indication
Postoperative