Free Gingival GraftNCT05779800
The Use of Flowable Resin Composite Stent in Reduction of Donor Site Morbidity After Free Gingival Graft Harvesting
A study testing Flowble resin composite stent and periodontal pack in people with Free Gingival Graft, run by Cairo University at 1 site in Egypt.
Trial summary
After harvesting free gingival graft from the hard palate, Postoperative pain as well as bleeding are the most common complications.Different agents were used to protect the denuded areas on the palate as gelatin sponge, Hyaluronic acid gel and platelet rich fibrin (PRF) but still no gold standard material is present. Read more about this study
- Who is it for?
- Ages 21 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Free Gingival Graft
- What is being tested?
- Flowble resin composite stent and periodontal pack
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2023to 5 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with mucogingival defects scheduled for free gingival graft or de-epithelialized connective tissue graft.
- Systemically healthy
Who cannot join
- Smokers
- Occlusal trauma at site of graft
- Pregnancy and lactation
- Patients allergic to the used agents
- Severe gagging reflex
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry, Cairo univesity
Cairo, Manial, 11
Ahmed M Barbari, A.Professor, 00201223153678, ahmed.barbari@dentistry.cu.edu.eg
Faculty of dentistry, Cairo univesity, 0020223642705, dentmail@dentistry.cu.edu.eg
About this study
Official title: Clinical Comparison of the Use of Flowable Resin Composite Stent Versus Periodontal Pack to Reduce Donor Site Morbidity After Free Gingival Graft Harvesting: A Randomized Clinical Trial
After harvesting free gingival graft from the hard palate, Postoperative pain as well as bleeding are the most common complications.Different agents were used to protect the denuded areas on the palate as gelatin sponge, Hyaluronic acid gel and platelet rich fibrin (PRF) but still no gold standard material is present.
PICO format:
Read more
P: patients with mucogingival problems in need for free gingival graft or de-epithelialized connective tissue graft.I: Flowable resin composite stent. C: Periodontal pack. O: Post-operative pain T: day 3, 7, 14, 21 and 42 postoperative.
Aim of the study:
To compare the effect of flowable composite stent versus periodontal pack applied to palatal donor site after free gingival graft harvesting in terms of post-operative pain reduction.
Read the detailed description
Intervention:
Flowable resin composite stent.
Procedure:
After the palatal sites be anaesthetized with 0.3 ml of a solution of 4% Articaine and 0.001% Adrenalin. Graft harvesting will be performed by basic surgical techniques described by Miller (1982). A rectangular shaped piece of mucosa will be harvested from the area of the hard palate by a split-thickness dissection.
The graft will then be used as it on the recipient bed. The graft dimensions will be recorded (width and length).
Denuded palatal area will then be protected using one of the following options:
- Periodontal pack (control group)
- flowble resin composite NEXOCOMP FLOW (intervention group)
Postoperative instructions:
Postoperative instructions will include discontinuing tooth brushing and flossing around the surgical sites until the day of periodontal dressing removal (day 7).
Patients will be directed to consume only soft foods during the first week and to avoid any mechanical trauma.
Patients will be scheduled to be seen on days 7, 14, 21 and 42 Periodontal pack and flowble resin composite stent will be first removed on day 7, and donor sites will be evaluated using selected parameters in both groups.
Thereafter, all patients will be followed up on days 14, 21 and 42 for further evaluation.
- Conditions
- Free Gingival Graft
- Being tested
- Flowble resin composite stent, periodontal pack
- Keywords
- palatal donor site, Gingival Recession, Periodontal Diseases, Protective Agents, flowable composite
- Medical subject headings
- Gingival Recession, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flowble resin composite stentDevice
Also called NEXOCOMP FLOW
Flowble resin composite is a filling material used in operative dentistry and characterized by being flow and easily adapting the surfaces.
periodontal packDevice
Also called COE-PAK
Non eugenol containing dressing supplied in two tubes
| Study group | Role | What they receive |
|---|---|---|
| Flowable resin composite stent group | Experimental | Flowable resin composite is a bio compatible material used in dental field many years ago. Receives: Device: Flowble resin composite stent |
| Periodontal pack group | Active comparator | Non eugenol containing periodontal pack used in periodontal surgeries to protect the wound.
Other name :COE_PAK Receives: Device: periodontal pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
Pain score reported by the patient directly through Visual Analogue Scale score (between 0 and 100. 0: no pain, 10: minimal pain, 50:moderate pain, 100: severe pain)
Measured: on day 7
Secondary outcomes (2)
Color match
The color of the palatal mucosa will be assessed by comparing it with that of the adjacent and opposite side by using the objective VAS (VAS score 0-10) represented by a continuous line, by a clinician blinded to the treatment group assignment.
Measured: On day 42
wound size
To be recorded using (UNC 15) periodontal probe to the nearest measurement of 0.5 mm , length and width only
Measured: at day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start15 Feb 2023
- Primary completion8 Nov 2023 (estimated)
- Study completion5 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Free Gingival GraftStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsayed Ahmed Hassan Temraz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779800
- Sponsor's protocol ID
- 9322
- Status last verified
- Mar 2023
- First submitted
- 25 Feb 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- 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 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of the Use of Flowable Resin Composite Stent Versus Periodontal Pack to Reduce Donor Site Morbidity After Free Gingival Graft Harvesting: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05779800
- Acronym / sponsor ID
- 9322
- Conditions
- Free Gingival Graft
- Keywords
- palatal donor site, Gingival Recession, Periodontal Diseases, Protective Agents, flowable composite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 8 Nov 2023 (estimated)
- Study completion
- 5 Dec 2023 (estimated)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After harvesting free gingival graft from the hard palate, Postoperative pain as well as bleeding are the most common complications.Different agents were used to protect the denuded areas on the palate as gelatin sponge, Hyaluronic acid gel and platelet rich fibrin (PRF) but still no gold standard material is present.
PICO format:
P: patients with mucogingival problems in need for free gingival graft or de-epithelialized connective tissue graft.I: Flowable resin composite stent. C: Periodontal pack. O: Post-operative pain T: day 3, 7, 14, 21 and 42 postoperative.
Aim of the study:
To compare the effect of flowable composite stent versus periodontal pack applied to palatal donor site after free gingival graft harvesting in terms of post-operative pain reduction.
Detailed description
Intervention:
Flowable resin composite stent.
Procedure:
After the palatal sites be anaesthetized with 0.3 ml of a solution of 4% Articaine and 0.001% Adrenalin. Graft harvesting will be performed by basic surgical techniques described by Miller (1982). A rectangular shaped piece of mucosa will be harvested from the area of the hard palate by a split-thickness dissection.
The graft will then be used as it on the recipient bed. The graft dimensions will be recorded (width and length).
Denuded palatal area will then be protected using one of the following options:
- Periodontal pack (control group)
- flowble resin composite NEXOCOMP FLOW (intervention group)
Postoperative instructions:
Postoperative instructions will include discontinuing tooth brushing and flossing around the surgical sites until the day of periodontal dressing removal (day 7).
Patients will be directed to consume only soft foods during the first week and to avoid any mechanical trauma.
Patients will be scheduled to be seen on days 7, 14, 21 and 42 Periodontal pack and flowble resin composite stent will be first removed on day 7, and donor sites will be evaluated using selected parameters in both groups.
Thereafter, all patients will be followed up on days 14, 21 and 42 for further evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flowable resin composite stent group | Experimental | Device: Flowble resin composite stentFlowable resin composite is a bio compatible material used in dental field many years ago. |
| Periodontal pack group | Active comparator | Device: periodontal packNon eugenol containing periodontal pack used in periodontal surgeries to protect the wound. Other name :COE_PAK |
Who may qualify
- Ages
- 21 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with mucogingival defects scheduled for free gingival graft or de-epithelialized connective tissue graft.
- Systemically healthy
Key exclusion criteria (5 listed)
- Smokers
- Occlusal trauma at site of graft
- Pregnancy and lactation
- Patients allergic to the used agents
- Severe gagging reflex
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 |
|---|---|---|
| Flowble resin composite stentAlso: NEXOCOMP FLOWFlowble resin composite is a filling material used in operative dentistry and characterized by being flow and easily adapting the surfaces. | Device | Flowable resin composite stent group |
| periodontal packAlso: COE-PAKNon eugenol containing dressing supplied in two tubes | Device | Periodontal pack group |
Primary outcome
Post operative pain
Time frame: on day 7
Pain score reported by the patient directly through Visual Analogue Scale score (between 0 and 100. 0: no pain, 10: minimal pain, 50:moderate pain, 100: severe pain)
2 secondary outcomes
Color match
Time frame: On day 42
wound size
Time frame: at day 21
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
Related trials for Free Gingival Graft
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Keratinized Tissue Augmentation Using Augmented Gingival Matrix Compared to Free Gingival Graft Around Implants
Keratinized Tissue Augmentation Around Dental Implants
Recruiting
Effects of Low-Level Laser Therapy and Hyaluronic Acid After Free Gingival Graft
Gingival Recession, Mucogingival Surgery
Not yet recruiting
Comparison of the Keratinized Tissue Gain in Frenal Relocation Alone to Frenal Relocation Combined With the Application of Free Gingival Graft in High Frenum Attachment in Adults
Keratinized Tissue Gain
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flowble resin composite stent and periodontal pack in people with Free Gingival Graft, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Mar 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed E Temraz, bachelor (00201020117827, mohamed.temraz@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain (time frame: on day 7). 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 22 Mar 2023.