The Influence of Tissue Adhesive to Palatal Donor Site Healing.

NCT04403503 | Completed

• 1 other identifier: Cyanoacrylate
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

CTG was harvested from 21 patients in each group. Donor site was treated with either GS (control) or GS+CY (test). Palatal tissue thickness, graft dimensions, working time (WT) and primary bleeding time were recorded intraoperatively. The data of pain perception (PP) will be measured using visual analog scale, quantity of analgesics (QA), secondary bleeding (SB), epithelization level (EL), and color match (CM) will be assessed prospectively. these outcomes will be evaluated in the first 7 days and 14th, 21th, and 28th days. Patient reported outcomes will be recorded using OHIB 14 questionnaire.

Conditions

Donor Site Complication

Outcome Measures

Primary Outcomes (1)

• Donor site pain perception (PP)

  Patients score their daily donor site pain perception (PP) level by giving numbers from 0 to 10 according to the visual analog scale (VAS) (0: no pain, 1: minimal pain, 10: severe pain)

  first week

Secondary Outcomes (10)

• Primary bleeding time (PBT)

  during surgery

• Graft height (GH)

  during surgery

• Graft width (GW)

  during surgery

• Graft thickness (GT)

  during surgery

• Working time (WT)

  during surgery

Study Arms (2)

Gelatine Sponge

ACTIVE COMPARATOR

After local anesthesia (2% articaine HCl with epinephrine 1:100,000) administration, palatal thickness was measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area and mean value was recorded as 'palatal tissue thickness (PTT)'. Epithelialized gingival graft was harvested with the method described by Zucchelli et al.19 After a rectangular shaped initial incision, graft with 1-1.5 mm thickness was harvested approximately 1.5 to 3 mm away from gingival margins of upper teeth. After harvesting, excess fatty tissues were removed and de-epithelialization was performed to obtain DGG. Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA)

Drug: Gelatin Sponge;Thrombin, Bovine 5000 IU Multiple Routes Kit [GELFOAM-JMI SPONGE KIT]

Gelatine sponge +Cyanoacrylate

ACTIVE COMPARATOR

After local anesthesia (2% articaine HCl with epinephrine 1:100,000) administration, palatal thickness was measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area and mean value was recorded as 'palatal tissue thickness (PTT)'. Epithelialized gingival graft was harvested with the method described by Zucchelli et al.19 After a rectangular shaped initial incision, graft with 1-1.5 mm thickness was harvested approximately 1.5 to 3 mm away from gingival margins of upper teeth. After harvesting, excess fatty tissues were removed and de-epithelialization was performed to obtain DGG. Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) and GS covered with high viscosity CY (PeriAcryl®, Glustitch Inc., Delta, Canada) (GS+CY group)

Drug: Cyanoacrylate, Isobutyl

Interventions

Gelatin Sponge;Thrombin, Bovine 5000 IU Multiple Routes Kit [GELFOAM-JMI SPONGE KIT] DRUG

Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) (GS group)

Gelatine Sponge

Cyanoacrylate, Isobutyl DRUG

Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) (GS group) and GS covered with high viscosity CY (PeriAcryl®, Glustitch Inc., Delta, Canada) (GS+CY group).

Gelatine sponge +Cyanoacrylate

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age ≥18;
• PPS indication that needs CTG in anterior mandible;
• stable periodontium after phase I therapy;
• full-mouth plaque and bleeding scores \<15%

You may not qualify if:

• previous palatal harvesting history;
• unstable endodontic conditions;
• tooth mobility at surgical site;
• systemic disease;
• pregnancy;
• use of medications with potential adverse effects to periodontal tissues

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Bucrylate

Intervention Hierarchy (Ancestors)

Cyanoacrylates; Acrylates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitriles; Enbucrilate; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Tissue Adhesives; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: One author (H.G.K.) randomly assigned the patients, with 1:1 allocation ratio, into GS and GS+CY groups by making simple randomization without blocking (computer-generated randomization scheme) (Figure 1). Number-labeled opaque envelopes containing the name of assigned method were used for allocation concealment. The surgical procedures were carried out by (B.T.Y.) whereas another author (E.C.) acquired the intra- and post-operative data. No information regarding to the applied hemostatic was given to the patients to preserve the patient blinding.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 27, 2020
• Study Start: July 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: March 1, 2019
• Last Updated: October 2, 2024

Record last verified: 2024-10

Locations

TU (1)