SurgeryNCT05684913
The Effects of Zn-containing Granulate on Patient Morbidity and Wound Healing After Free Gingival Graft Surgery
A study testing Zn granulate stent after FGG surgery and Hemostatic agent suturing in people with Surgery, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
There is no study in the literature showing the effects of Zn on wound healing after free gingival graft (FGG) operation. The aim of this randomized clinical study was to compare the early healing results of the palatal wound after FGG harvesting by sterile hemostatic agent suturing or the use of surgical stent from… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- Zn granulate stent after FGG surgery and Hemostatic agent suturing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2022to 10 Dec 2022
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Periodontal and systemically healthy
- ≥19 years old
- Amount of attached gingival width in the maxillary or mandibular anterior region <2 mm
- Full mouth plaque index score, bleeding index score on full-mouth probing <15%
Who cannot join
- Previously undergone surgery for a graft harvested from the palate
- Presence of systemic disease
- Taking medication known to interfere with periodontal health
- Smoking
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cukurova University Faculty of Dentistry
Adana, 01330
About this study
Official title: Cukurova University Faculty of Dentistry
There is no study in the literature showing the effects of Zn on wound healing after free gingival graft (FGG) operation. The aim of this randomized clinical study was to compare the early healing results of the palatal wound after FGG harvesting by sterile hemostatic agent suturing or the use of surgical stent from thermoplastic Zn-containing granules which was prepared chairside.
Read the detailed description
There are many studies reporting paresthesia, herpetic lesion, mucocele, excessive bleeding and severe postoperative pain after procedure.The highest pain level perceived in the palatal region after the FGG operation is experienced on the first day after the operation and decreases to the preoperative levels approximately 2 weeks after the operation. Although hemostatics, bioactive substances, antibacterial and antiseptic agents, herbal effective products, platelet concentrations, low-dose laser applications, palatal stents are used in the palatal region to accelerate the healing stages and prevent such complications, an ideal support has not been found.
- Conditions
- Surgery
- Being tested
- Zn granulate stent after FGG surgery, Hemostatic agent suturing
- Keywords
- free gingival graft surgery, surgical stent, zinc, pain, bleeding
- Medical subject headings
- Pain, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zn granulate stent after FGG surgeryProcedure or surgery
Immediately after FGG harvesting from the palatal tissue, homeostasis was achieved by sterile wet gauzes and the ZnG was prepared according to the manufacturer guidelines. Briefly, approximately 10 grams of granulate was poured into hot water and then manually shaped to cover the surgical area. The retention was achieved from the palatal, occlusal and buccal surfaces of the teeth. The patient was asked to wear the ZnG for 7 days except for eating.(
Hemostatic agent suturingProcedure or surgery
Immediately after FGG harvesting from the palatal tissue, homeostasis was achieved by sterile wet gauzes. Then hemostatic agent containing cellulose were sutured on the palatal wound area with 4.0 vicryl sutures in this group. Sutures were removed after 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Zinc granulate group | Experimental | The patients in this group will receive a chair-side prepared surgical stent from Zn granulates on the palatal wound after FGG surgery. Receives: Procedure: Zn granulate stent after FGG surgery |
| Hemostatic agent group | Active comparator | The patients in this group will receive hemostatic agent sutured on the palatal wound after FGG surgery. Receives: Procedure: Hemostatic agent suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Pain was scored from 0 to 10 experienced by the patients as a result of palatal wound (0: no pain, 1: minimal pain, 10: severe pain).
Measured: post operative 8 weeks
Secondary outcomes (5)
Bleeding
Bleeding of the palatal wound was described as prolonged hemorrhaging after the surgery and was recorded 'yes' or 'no'
Measured: post operative 7 days
Burning sensation
BS was assessed as the level of sense of burning of the palatal wound via Visual Analogue Scale (0:absent 10:severe burning)
Measured: post operative 8 weeks
Change in dietary habits
evaluated according to inability to chew resulting from the presence of the palatal wound via Visual Analogue Scale (0: no changes 10: not capable of eating)
Measured: post operative 8 weeks
Complete epithelization
evaluated clinically with the 3% Hydrogen Peroxide test. While the H2O2 epithelial barrier is intact, it doesn't diffuse into the connective tissue, and oxygen isn't released. The absence of bubbles after H2O2 application was considered as CE positive, and CE was recorded as a triple variable
Measured: post-operative 8 weeks
Patient discomfort
PD was assessed by application of air spray for 5 seconds over the palatal site and then patients scored the VAS considering sensitive function (0: no discomfort, 10: extreme).
Measured: post-operative 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start20 Mar 2022
- Primary completion15 Nov 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Ozcan, Cukurova University
- Investigators
- Cenk Haytac, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684913
- Sponsor's protocol ID
- CukurovaU-4
- Status last verified
- Jan 2023
- First submitted
- 14 Dec 2022
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cukurova University Faculty of Dentistry
- ClinicalTrials.gov ID
- NCT05684913
- Acronym / sponsor ID
- CukurovaU-4
- Conditions
- Surgery
- Keywords
- free gingival graft surgery, surgical stent, zinc, pain, bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 13 Jan 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.
There is no study in the literature showing the effects of Zn on wound healing after free gingival graft (FGG) operation. The aim of this randomized clinical study was to compare the early healing results of the palatal wound after FGG harvesting by sterile hemostatic agent suturing or the use of surgical stent from thermoplastic Zn-containing granules which was prepared chairside.
Detailed description
There are many studies reporting paresthesia, herpetic lesion, mucocele, excessive bleeding and severe postoperative pain after procedure.The highest pain level perceived in the palatal region after the FGG operation is experienced on the first day after the operation and decreases to the preoperative levels approximately 2 weeks after the operation. Although hemostatics, bioactive substances, antibacterial and antiseptic agents, herbal effective products, platelet concentrations, low-dose laser applications, palatal stents are used in the palatal region to accelerate the healing stages and prevent such complications, an ideal support has not been found.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc granulate group | Experimental | Procedure: Zn granulate stent after FGG surgeryThe patients in this group will receive a chair-side prepared surgical stent from Zn granulates on the palatal wound after FGG surgery. |
| Hemostatic agent group | Active comparator | Procedure: Hemostatic agent suturingThe patients in this group will receive hemostatic agent sutured on the palatal wound after FGG surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Periodontal and systemically healthy
Key exclusion criteria (4 listed)
- Previously undergone surgery for a graft harvested from the palate
- Presence of systemic disease
- Taking medication known to interfere with periodontal health
- Smoking
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 |
|---|---|---|
| Zn granulate stent after FGG surgeryImmediately after FGG harvesting from the palatal tissue, homeostasis was achieved by sterile wet gauzes and the ZnG was prepared according to the manufacturer guidelines. Briefly, approximately 10 grams of granulate was poured into hot water and then manually shaped to cover the surgical area. The retention was achieved from the palatal, occlusal and buccal surfaces of the teeth. The patient was asked to wear the ZnG for 7 days except for eating.( | Procedure or surgery | Zinc granulate group |
| Hemostatic agent suturingImmediately after FGG harvesting from the palatal tissue, homeostasis was achieved by sterile wet gauzes. Then hemostatic agent containing cellulose were sutured on the palatal wound area with 4.0 vicryl sutures in this group. Sutures were removed after 7 days. | Procedure or surgery | Hemostatic agent group |
Primary outcome
Post-operative pain
Time frame: post operative 8 weeks
Pain was scored from 0 to 10 experienced by the patients as a result of palatal wound (0: no pain, 1: minimal pain, 10: severe pain).
5 secondary outcomes
Bleeding
Time frame: post operative 7 days
Burning sensation
Time frame: post operative 8 weeks
Change in dietary habits
Time frame: post operative 8 weeks
Complete epithelization
Time frame: post-operative 8 weeks
Patient discomfort
Time frame: post-operative 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Cenk Haytac study director
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zn granulate stent after FGG surgery and Hemostatic agent suturing in people with Surgery, run by Cukurova University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 13 Jan 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post-operative pain (time frame: post operative 8 weeks). 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 13 Jan 2023.