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

NCT03895476 | Completed Results

• 2 other identifiers: IRB-300002777UAB Periodontology
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gingival Recession; Palate; Wound

Outcome Measures

Primary Outcomes (2)

• Pain Assessment (0=No Pain to 10=Worst)

  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.

  day 14

• Bleeding Assessment

  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.

  day 14

Secondary Outcomes (3)

• Activity Tolerance

  day 14

• Amount of Swelling

  day 14

• The Need for Painkiller

  day 14

Study Arms (4)

Collagen Plug with sutures

ACTIVE COMPARATOR

Palatal wound will be protected with collagen plug and sutures.

Diagnostic Test: palatal wound will be cover with collagen and sutures

Platelet Rich Fibrin (PRF)

ACTIVE COMPARATOR

palatal wound will be protected with Platelet rich Fibrin

Diagnostic Test: palatal wound covered with platelet rich fibrin

Collagen Plug with Cyanoacrylate (CPC)

ACTIVE COMPARATOR

Palatal wound will consist of collagen protection with the additional layer of cyanoacrylate surgical glue.

Diagnostic Test: palatal wound covered with a collagen sponge and cyanoacrylate

Palatal Stent

ACTIVE COMPARATOR

Palatal wound will be protected with palatal stent.

Diagnostic Test: palatal wound covered with a stent

Interventions

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

Collagen Plug with sutures

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

Platelet Rich Fibrin (PRF)

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

Collagen Plug with Cyanoacrylate (CPC)

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

Palatal Stent

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Unversity of Alabama at Birmingham, School of Dentistry

Birmingham, Alabama, 35294-0007, United States

Location

MeSH Terms

Conditions

Gingival Recession; Wounds and Injuries

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Results Point of Contact

• Title: Hussein Basma, DDS, MS
• Organization: University of Alabama at Birmingham

basma86@uab.edu

2059344506

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 29, 2019
• Study Start: June 8, 2020
• Primary Completion: July 30, 2021
• Study Completion: February 27, 2023
• Last Updated: August 23, 2024
• Results First Posted: August 23, 2024

Record last verified: 2024-08

Locations

US (1)