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Completed

NCT Number: NCT06583226

The Effect of Two Different Approaches on Palatal Donor Site

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.

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Key information

Conditions

Wound Heal

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, Fatih, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%

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

Treatment and study plan

Gelatin sponge stabilization with suture and cyanoacrylate

Device

The donor site will be closed both with gelatin sponge +Cyanoacrylate (Spongostan®, Ethicon, USA)+ supporting sutures (control group)

Gelatin sponge stabilization with suture and cyanoacrylate and coconut oil application

Procedure

Seconder The donor site will be closed both with gelatin sponge +Cyanoacrylate (Spongostan®, USA) and coconut oil (test group)

Primary outcomes

  1. Donor site pain perception

    Time frame: 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)

  2. Secondary bleeding time

    Time frame: during first week

    Patients will record presence or absence of secondary bleeding (presence=1 or absence=0).

Secondary outcomes

  1. Graft height

    Time frame: during surgery

    Dimensions will be measured during surgery by clinician using Michigan O probe (will be reported in mm)

  2. Graft width

    Time frame: during surgery

    Dimensions will be measured during surgery by clinician using Michigan O probe.(will be reported in mm)

  3. Graft thickness

    Time frame: during surgery

    Dimensions will be measured during surgery by clinician using Michigan O probe (will be reported in mm)

  4. Working time

    Time frame: during surgery

    Harvesting process will be recorded by an blinded research assistant

  5. Quantity of analgesics

    Time frame: first week

    Patients recorded the quantity of analgesics taken will be reported as quantity of pill

  6. Sensation loss

    Time frame: 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

  7. Color match

    Time frame: 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)

  8. Epithelization level

    Time frame: 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

  9. The Oral Health Impact Profile-14 is a questionnaire that measures how oral disorders impact a patient's quality of life.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

The Effect of Two Different Approaches on Palatal Donor Site Management After De-epithelialized Graft Harvesting: Randomized Clinical Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 3, 2024
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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