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Completed

NCT Number: NCT03895476

To Measure Pain Perception Following De-Epithelized Free Gingival Graft Harvesting

This randomized clinical comparative study will evaluate the postoperative pain following the FGG graft harvest procedure technique covered by four different methods for coverage of the palatal donor site.

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Palate; Wound Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unversity of Alabama at Birmingham, School of Dentistry

Birmingham, Alabama, 35294-0007, United States

About this study

This study will compare the application of :

  • hemostatic collagen sponge
  • collagen sponge sealed with abio-adhesive material
  • Platelet rich fibrin
  • physical barrier (stent) on the palatal donor sites with the purpose of which one of these will result in least postoperative pain after epithelialized gingival graft (EGG) harvesting.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • English speaking
  • At least 18 years old- 70 years old
  • Must be a patient of the UAB Dental School
  • Able to read and understand informed consent document
  • Patients needing soft tissue graft with teeth that have miller class I or II recession (>=2mm) on the facial aspects
  • Presence of periodontally healthy teeth at the recipient site.
  • Ability of the participants to maintain good oral hygiene
  • Patient not pregnant or breastfeeding
  • Not taking medications known to cause gingival enlargement

Exclusion criteria

  • Non-English speaking
  • Less than 18 years old, older than 70 years old
  • Smokers/tobacco users
  • Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
  • Patients that have severe gingival recession (Miller class III and IV) or < 2 mm.
  • Presence of periodontal disease at the recipient site.
  • Poor oral hygiene
  • Patient pregnant or breastfeeding
  • Taking medications known to cause gingival enlargement

Treatment and study plan

palatal wound will be cover with collagen and sutures

Diagnostic Test

after harvesting the graft from the palate, a collagen sponge will be sutured to cover the harvested site

palatal wound covered with platelet rich fibrin

Diagnostic Test

after harvesting the graft from the palate the platelet rich fibrin will be sutured to covered the harvested site

palatal wound covered with a collagen sponge and cyanoacrylate

Diagnostic Test

after harvesting the graft from the palate a collagen sponge will be sealed with cyanoacrylate in position

palatal wound covered with a stent

Diagnostic Test

after harvesting the graft from the palate a stent that will be prepared for the patient, will be placed on to cover the wound

Primary outcomes

  1. Pain Assessment (0=No Pain to 10=Worst)

    Time frame: day 14

    To assess the pain outcomes using the visual analog scale from 0=No pain to 10=worst, excrutiating pain. Assessed daily from days 1 to 14, Day 14 reported.

  2. Bleeding Assessment

    Time frame: day 14

    To assessed the bleeding outcomes using the visual analog scale (VAS) from 0=No bruising/bleeding to 10=severe bruising/bleeding. Assessed daily from days 1 to 14, Day 14 reported.

Secondary outcomes

  1. Activity Tolerance

    Time frame: day 14

    To assess the effects on daily activities using the visual analog scale from 0=No Limitation to 10= Bedrest required. Assessed daily from days 1 to 14, Day 14 reported.

  2. Amount of Swelling

    Time frame: day 14

    To assessed the swelling outcomes using the visual scale (VAS) from 0=No swelling to 10=severe swelling. Assessed daily from days 1 to 14, Day 14 reported.

  3. The Need for Painkiller

    Time frame: day 14

    To assess the needs for the painkiller using the visual analog scale (VAS). (0 = No painkiller needed to 10 = Needed painkiller). Assessed daily from days 1 to 14, Day 14 reported.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

A Randomized Controlled Trial to Measure Pain Perception Following De-Epithelized Free Gingival Graft Harvesting

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Mar 29, 2019
Registry last updated
Aug 23, 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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