Gingival RecessionNCT03895476
To Measure Pain Perception Following De-Epithelized Free Gingival Graft Harvesting
A study testing palatal wound will be cover with collagen and sutures, palatal wound covered with platelet rich fibrin and palatal wound covered with a collagen sponge and cyanoacrylate in people with Gingival Recession and Palate; Wound, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Palate; Wound
- What is being tested?
- palatal wound will be cover with collagen and sutures, palatal wound covered with platelet rich fibrin and palatal wound covered with a collagen sponge and cyanoacrylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2020to 27 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- Ability of the participants to maintain good oral hygiene
- Patient not pregnant or breastfeeding
- Not taking medications known to cause gingival enlargement
Who cannot join
- 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.
Show all 9Show fewer
- Poor oral hygiene
- Patient pregnant or breastfeeding
- Taking medications known to cause gingival enlargement
Trial locations and contacts
1 site in 1 country.
United States1 site
Unversity of Alabama at Birmingham, School of Dentistry
Birmingham, Alabama, 35294-0007
About this study
Official title: A Randomized Controlled Trial 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.
Read the detailed description
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.
- Conditions
- Gingival Recession, Palate; Wound
- Being tested
- palatal wound will be cover with collagen and sutures, palatal wound covered with platelet rich fibrin, palatal wound covered with a collagen sponge and cyanoacrylate, palatal wound covered with a stent
- Medical subject headings
- Gingival Recession, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palatal wound will be cover with collagen and suturesDiagnostic 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 fibrinDiagnostic 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 cyanoacrylateDiagnostic test
after harvesting the graft from the palate a collagen sponge will be sealed with cyanoacrylate in position
palatal wound covered with a stentDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Collagen Plug with sutures | Active comparator | Palatal wound will be protected with collagen plug and sutures. Receives: 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 Receives: 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. Receives: Diagnostic Test: palatal wound covered with a collagen sponge and cyanoacrylate |
| Palatal Stent | Active comparator | Palatal wound will be protected with palatal stent. Receives: Diagnostic Test: palatal wound covered with a stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: day 14
Secondary outcomes (3)
Activity Tolerance
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.
Measured: day 14
Amount of Swelling
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.
Measured: day 14
The Need for Painkiller
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.
Measured: day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start8 Jun 2020
- Primary completion30 Jul 2021
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein Basma, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895476
- Sponsor's protocol ID
- IRB-300002777
- Other IDs
- UAB Periodontology
- Status last verified
- Aug 2024
- First submitted
- 26 Mar 2019
- Last updated
- 23 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Measure Pain Perception Following De-Epithelized Free Gingival Graft Harvesting
- ClinicalTrials.gov ID
- NCT03895476
- Acronym / sponsor ID
- IRB-300002777
- Conditions
- Gingival Recession, Palate; Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 29 Mar 2019 (actual)
- Results
- Posted 23 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Collagen Plug with sutures | Active comparator | Diagnostic Test: palatal wound will be cover with collagen and suturesPalatal wound will be protected with collagen plug and sutures. |
| Platelet Rich Fibrin (PRF) | Active comparator | Diagnostic Test: palatal wound covered with platelet rich fibrinpalatal wound will be protected with Platelet rich Fibrin |
| Collagen Plug with Cyanoacrylate (CPC) | Active comparator | Diagnostic Test: palatal wound covered with a collagen sponge and cyanoacrylatePalatal wound will consist of collagen protection with the additional layer of cyanoacrylate surgical glue. |
| Palatal Stent | Active comparator | Diagnostic Test: palatal wound covered with a stentPalatal wound will be protected with palatal stent. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| palatal wound will be cover with collagen and suturesafter harvesting the graft from the palate, a collagen sponge will be sutured to cover the harvested site | Diagnostic test | Collagen Plug with sutures |
| palatal wound covered with platelet rich fibrinafter harvesting the graft from the palate the platelet rich fibrin will be sutured to covered the harvested site | Diagnostic test | Platelet Rich Fibrin (PRF) |
| palatal wound covered with a collagen sponge and cyanoacrylateafter harvesting the graft from the palate a collagen sponge will be sealed with cyanoacrylate in position | Diagnostic test | Collagen Plug with Cyanoacrylate (CPC) |
| palatal wound covered with a stentafter harvesting the graft from the palate a stent that will be prepared for the patient, will be placed on to cover the wound | Diagnostic test | Palatal Stent |
Primary outcome
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.
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.
3 secondary outcomes
Activity Tolerance
Time frame: day 14
Amount of Swelling
Time frame: day 14
The Need for Painkiller
Time frame: day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing palatal wound will be cover with collagen and sutures, palatal wound covered with platelet rich fibrin and palatal wound covered with a collagen sponge and cyanoacrylate in people with Gingival Recession and Palate; Wound, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Assessment (0=No Pain to 10=Worst) (time frame: day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.