The Influence of Tissue Adhesive to Palatal Donor Site Healing.

• Sponsor: Hacettepe University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04403503
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2
• Actual Duration (Months): 8
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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. Patients recorded the quantity of analgesics (QA) taken, presence of secondary bleeding (SB) and pain perception (PP) daily for first postoperative week. Sensation loss (SL), color match (CM), epithelization level (EL) were evaluated at days 7, 14, 21 and 28.

Condition or Disease	Intervention/Treatment	Phase
Donor Site Complication	Drug: Gelatin Sponge;Thrombin, Bovine 5000 IU Multiple Routes Kit [GELFOAM-JMI SPONGE KIT]; Drug: Cyanoacrylate, Isobutyl	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Supportive Care
• Official Title: The Influence of Tissue Adhesive to Palatal Donor Site Healing. A Randomized Controlled Clinical Trial
• Actual Study Start Date: Jul 1, 2018
• Actual Primary Completion Date: Feb 1, 2019
• Actual Study Completion Date: Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Gelatine Sponge 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]; Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) (GS group)
Active Comparator: Gelatine sponge +Cyanoacrylate 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; 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).

Outcome Measures

Primary Outcome Measures

1. Donor site pain perception (PP) [first week]

   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)

Secondary Outcome Measures

1. Primary bleeding time (PBT) [during surgery]

   Immediately after harvesting, sterile gauze was compressed to the palatal wound for 2 minutes, blood wiped once in every 30 seconds until bleeding stops. The duration was recorded as primary bleeding time (PBT).

2. Graft height (GH) [during surgery]

   Dimensions were measured with periodontal probe

3. Graft width (GW) [during surgery]

   Dimensions were measured with periodontal probe

4. Graft thickness (GT) [during surgery]

   Dimensions were measured with periodontal probe

5. Working time (WT) [during surgery]

   Harvesting process was recorded

6. Quantity of analgesics (QA) [first week]

   Patients recorded the quantity of analgesics (QA) taken

7. Secondary bleeding (SB) [first week]

   Patients recorded presence/absence of secondary bleeding (SB) (yes or no).

8. Sensation loss (SL) [first week, second week , third week, fourth week.]

   Sensation loss (SL) was scored as none, medium or severe

9. Color match (CM) [first week, second week, third week, fourth week.]

   Color match (CM) with the adjacent tissue was determined by using a VAS scale (0: absence of harmony, 10: excellent harmony)

10. Epithelization level (EL) [first week, second week, third week, fourth week.]

    Epithelization level (EL) was scored as none, partial or full epithelization by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface following surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• age ≥18;

• PPS indication that needs CTG in anterior mandible;

• stable periodontium after phase I therapy;

• full-mouth plaque and bleeding scores <15%

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hacettepe University	Ankara		Turkey	06100

Sponsors and Collaborators

• Hacettepe University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gencay Keceli, Assoc. Prof. Dr., Hacettepe University
• ClinicalTrials.gov Identifier: NCT04403503
• Other Study ID Numbers: Cyanoacrylate
• First Posted: May 27, 2020
• Last Update Posted: May 29, 2020
• Last Verified: May 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Thrombin; Gelatin Sponge, Absorbable

Study Results

No Results Posted as of May 29, 2020