The Effect of Two Different Approaches on Palatal Donor Site

Not Applicable

Completed

• Conditions: Wound Heal
• Interventions: Device: Gelatin sponge stabilization with suture and cyanoacrylate; Procedure: Gelatin sponge stabilization with suture and cyanoacrylate and coconut oil application

• Registration Number: NCT06583226
• Lead Sponsor: Medipol University

Brief Summary

An epithelialized gingival graft will be harvested from the palate for the treatment of various mucogingival deformities. The donor site will be treated with either a combination of a collagen sponge, cyanoacrylate and suspending sutures or a collagen sponge, cyanoacrylate, suspending sutures and coconut oil.

Detailed Description

After epithelialized gingival graft harvesting, intraoperatively, measurements will be taken for palatal tissue thickness, graft dimensions, working time, and primary bleeding time. Data regarding pain perception will be gauged using a visual analog scale, and the number of analgesics, secondary bleeding, epithelization level, and color match will be assessed prospectively. These outcomes will be evaluated on the first 7 days and subsequently on the 14th, 21st, and 28th days. Patient-reported outcomes will be recorded using the Oral Health Impact Profile-14 questionnaire.

Study Timeline

• Study Start: 2023-10-10
• Primary Completion: 2024-05-20
• Study Completion: 2024-05-20
• Status Verified: 2024-09
• Study First Submitted: 2024-09-01
• Study First Submitted QC: 2024-09-01
• Last Update Submitted: 2024-09-01
• Study First Posted: 2024-09-03
• Last Update Posted: 2024-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

age ≥18; mucogingival surgical treatment indication that needs connective tissue graft in the 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 the surgical site; systemic disease; pregnancy; use of medications with potential adverse effects on periodontal tissues

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gelatin sponge + cyanoacrylate + suspending sutures	Gelatin sponge stabilization with suture and cyanoacrylate	After administration of local anesthesia (2% articaine hydrochloride with epinephrine 1:100,000), palatal thickness will be measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area. Epithelialized gingival graft will be harvested. After a rectangular-shaped initial incision, a graft with 1-1.5 mm thickness will be harvested approximately 1.5 to 3 mm away from the gingival margins of the upper teeth. The donor site will be closed with a gelatin sponge + cyanoacrylate + suspending sutures.
gelatin sponge + cyanoacrylate + suspending sutures + coconut oil	Gelatin sponge stabilization with suture and cyanoacrylate and coconut oil application	After local anesthesia (2% articaine hydrochloride with epinephrine 1:100,000) administration, palatal thickness will be measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area and the mean value will be recorded as palatal tissue thickness. The epithelialized gingival graft will be harvested using 15 knives. After a rectangular-shaped initial incision, a graft with 1-1.5 mm thickness will be harvested approximately 1.5 to 3 mm away from the gingival margins of the upper teeth. The donor site will be closed with a gelatin sponge, cyanoacrylate suspending sutures and coconut oil.

Primary Outcome Measures

Name	Time	Method
Donor site pain perception	everyday in first week	Patients score their daily donor site pain perception using visual analog score level by giving numbers from 0 to 10 according to the visual analog scale (0: no pain, 1: minimal pain, 10: severe pain)
Secondary bleeding time	during first week	Patients will record presence or absence of secondary bleeding (presence=1 or absence=0).

Secondary Outcome Measures

Name	Time	Method
Graft thickness	during surgery	Dimensions will be measured during surgery by clinician using Michigan O probe (will be reported in mm)
Working time	during surgery	Harvesting process will be recorded by an blinded research assistant
Graft height	during surgery	Dimensions will be measured during surgery by clinician using Michigan O probe (will be reported in mm)
Graft width	during surgery	Dimensions will be measured during surgery by clinician using Michigan O probe.(will be reported in mm)
Quantity of analgesics	first week	Patients recorded the quantity of analgesics taken will be reported as quantity of pill
Sensation loss	first week, second week , third week, fourth week.	Sensation loss will be scored by the help of clinician comparing with the symmetrical side an will be recorded as no-loss, medium loss or severe loss
Color match	first week, second week, third week, fourth week.	Color match with the adjacent tissue was determined by researcher using a Visual Analog Pain Scale scale (0: absence of harmony, 10: excellent harmony)
Epithelization level	first week, second week, third week, fourth week.	Epithelization level was scored by researcher as none, partial or full epithelization by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface
The Oral Health Impact Profile-14 is a questionnaire that measures how oral disorders impact a patient's quality of life.	first week	The questionnaire has 14 items with answers rated on a 5-point Likert scale (from 1 = never to 5 = very often) to indicate a level of different problems related to oral health

Trial Locations

Locations (1)

Istanbul Medipol University; 🇹🇷 Istanbul, Fatih, Turkey