The Influence of Tissue Adhesive to Palatal Donor Site Healing.

Not Applicable

Completed

• Conditions: Donor Site Complication
• Interventions: Drug: Gelatin Sponge;Thrombin, Bovine 5000 IU Multiple Routes Kit [GELFOAM-JMI SPONGE KIT]; Drug: Cyanoacrylate, Isobutyl

• Registration Number: NCT04403503
• Lead Sponsor: Hacettepe University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-07-01
• Primary Completion: 2019-02-01
• Study Completion: 2019-03-01
• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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%

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gelatine Sponge	Gelatin Sponge;Thrombin, Bovine 5000 IU Multiple Routes Kit [GELFOAM-JMI SPONGE KIT]	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)
Gelatine sponge +Cyanoacrylate	Cyanoacrylate, Isobutyl	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)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Quantity of analgesics (QA)	first week	Patients recorded the quantity of analgesics (QA) taken
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).
Graft height (GH)	during surgery	Dimensions were measured with periodontal probe
Graft width (GW)	during surgery	Dimensions were measured with periodontal probe
Graft thickness (GT)	during surgery	Dimensions were measured with periodontal probe
Working time (WT)	during surgery	Harvesting process was recorded
Secondary bleeding (SB)	first week	Patients recorded presence/absence of secondary bleeding (SB) (yes or no).
Sensation loss (SL)	first week, second week , third week, fourth week.	Sensation loss (SL) was scored as none, medium or severe
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)
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

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey