Recession, GingivalNCT06782035
The Effect of Periodontal Dressings and Various Materials on the Donor Site's Quality of Life After Free Gingival Graft Surgery
A study testing Ora-Aid-Oral Wound Dressing, Platelet rich fibrin and Palatal Stent in people with Recession, Gingival, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The inadequate width of attached gingiva, resulting from the loss of the attached gingiva band, is one of the primary mucogingival issues. Free gingival graft (FGG) is a mucogingival surgical technique used to increase the amount of attached gingiva, cover exposed root surfaces in localized gingival recessions, deepen… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Recession, Gingival
- What is being tested?
- Ora-Aid-Oral Wound Dressing, Platelet rich fibrin and Palatal Stent
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2025to 25 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systemically healthy Non-smoker Insufficient attached gingiva Not using any medication regularly Age 18-85 years No previous graft taken from the same area Not in pregnancy or lactation period Agreement to participate in the study and sign the "Informed Consent Form"
Who cannot join
- Systemic disease Regular systemic medication use Under 18 years old Pregnant or breastfeeding women Smoker Previous graft taken from the same area
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Izmir Katip Celebi University Faculty of Dentistry Department of Periodontology
Izmir
Sare Eröz, Research Assistant, +90 (537) 648 9064, sareeroz@gmail.com
Sare Eröz, Research Assistant
About this study
Official title: The Influence of Periodontal Dressings (Ora-Aid) and Various Materials on the Donor Site's Quality of Life After Free Gingival Graft Surgery
The inadequate width of attached gingiva, resulting from the loss of the attached gingiva band, is one of the primary mucogingival issues. Free gingival graft (FGG) is a mucogingival surgical technique used to increase the amount of attached gingiva, cover exposed root surfaces in localized gingival recessions, deepen the vestibule, and eliminate frenulum and muscle attachments. The harvested tissue is keratinized attached gingiva. Due to ease of access, the palate is most commonly preferred as the donor site.
Complications that may arise following FGG surgery are generally donor site-related. Reported complications include postoperative bleeding, recurrent herpetic lesions, delayed healing, paresthesia, mucocele, arteriovenous shunt, and postoperative pain. To aid healing and reduce discomfort and pain associated with the wound site in the palate after surgery, various materials have been applied to the donor site to facilitate recovery.
Read more
Following FGG surgery, patients will be divided into three groups based on the application of different materials to the wound site in the palate: leukocyte- and platelet-rich fibrin (L-PRF), Ora-Aid oral wound dressing, and a palatal surgical stent. In the Ora-Aid group, after harvesting the graft and placing it in the recipient site, the wound area will be irrigated with saline solution, and Ora-Aid will be trimmed to the appropriate size and shape. It will be gently pressed onto the wound for 5-10 seconds until it adheres. Ora-Aid and L-PRF will be secured to the wound site with a 4/0 silk cross suture. The Ora-Aid application will serve as the test group, the L-PRF application as the positive control group, and the palatal surgical stent as the negative control group. Randomization will be performed using a computer program.
Postoperatively, patients' pain levels will be assessed on the 3rd, 7th, and 14th days using the Visual Analog Scale (VAS) test and the OHIP-14 questionnaire. Wound site epithelialization will be evaluated during follow-up sessions on the 7th and 14th days and at 1 month. After evaluating all questionnaire results, statistical analyses will be conducted.
Read the detailed description
Clinically, the gingiva is part of the oral mucosa and periodontium that covers the alveolar processes of the jaws and surrounds the cervical portions of the teeth. Topographically, it is divided into free, attached, and interdental gingiva. Following tooth eruption, the gingival margin is located 0.5-2 mm coronally to the cementoenamel junction (CEJ). Histologically, the gingiva consists of epithelium and connective tissue. Anatomically and clinically, it is divided into three distinct regions: free gingiva, interdental gingiva, and attached gingiva.
Mucogingival issues arise as a result of insufficient attached gingiva. A thick keratinized attached gingiva is necessary to protect against masticatory trauma. When attached gingiva is reduced, plaque control becomes difficult, and the area becomes prone to inflammation. For periodontal health, 2 mm of attached gingiva is considered essential. The protective barrier function of attached gingiva prevents free gingival margin movement caused by the effects of perioral muscles in cases of insufficient attached gingiva. Movement of the gingival margin increases the risk of inflammation progression and gingival recession.
Free gingival graft (FGG) is one of the mucogingival surgical procedures used to increase the amount of attached gingiva, cover exposed root surfaces in localized gingival recession, deepen the vestibule, and eliminate frenulum and muscle attachments. The harvested tissue is keratinized attached gingiva. During the FGG procedure, vestibular depth increases, allowing patients to perform brushing more comfortably. The tuberosity region, edentulous alveolar crest, and hard palate are commonly preferred as donor sites due to ease of access.
Post-FGG complications are generally related to the donor site and include postoperative bleeding, recurrent herpetic lesions, delayed healing, paresthesia, mucocele, arteriovenous shunt, and postoperative pain. The palatal donor site often causes more discomfort and pain during the healing process. To support healing, various procedures have been implemented for the palatal donor site, including palatal stent + periodontal dressing application, suturing of hemostatic sponges, and surgical cauterization or laser application.
Recent studies report that Platelet-Rich Fibrin (PRF) accelerates healing and reduces postoperative morbidity when used to cover palatal wounds. Studies have shown that PRF supports "immunity," "angiogenesis," and "cellular proliferation," which play key roles in wound healing. Its use in non-healing wounds and surgical areas left for secondary healing has garnered significant attention. Choukroun developed a method to obtain leukocyte- and platelet-rich fibrin (L-PRF) by centrifuging 9 ml of whole venous blood in non-anticoagulant tubes at 2700 rpm for 12 minutes at room temperature. The process produces three layers within the tube: platelet-poor plasma at the top, red blood cells at the bottom, and L-PRF, a fibrin structure rich in platelets and growth factors, in the middle. The L-PRF layer is extracted with forceps, separated from the red blood cell layer using scissors, and compressed between two metal trays in a sterile container to form a 1-mm-thick membrane for clinical use.
Ora-Aid wound dressing is a relatively new material used for palatal donor site healing following FGG surgery. The adhesive side of Ora-Aid is applied directly to the oral mucosa, forming a protective layer. Ora-Aid offers advantages such as aiding hemostasis, providing physical protection against food particles, bacterial irritants, and smoking, and reducing oral malodor with its natural mint flavor. Another advantage is that it naturally detaches without requiring an additional appointment for removal. Ora-Aid consists of hydrophilic high-density polymers encapsulated within water-insoluble mucoadhesive synthetic cellulose and contains vitamin E, which has wound-healing and hemostatic effects. It is available in two sizes: 50 mm × 20 mm and 25 mm × 15 mm.
After harvesting the FGG, the palatal wound is irrigated with saline solution, and Ora-Aid is trimmed to the appropriate size and shape. It is then peeled from its transparent film and applied to the wound using forceps. The dressing is gently pressed for 5-10 seconds until it adheres to the wound. Ora-Aid use has demonstrated superior results for both patients and clinicians, being effective in reducing postoperative pain and enhancing wound healing. It holds significant potential as a palatal wound dressing material.
The aim of this study is to evaluate the quality of life in patients receiving L-PRF and periodontal dressings on the donor site after free gingival graft surgery.
- Conditions
- Recession, Gingival
- Being tested
- Ora-Aid-Oral Wound Dressing, Platelet rich fibrin, Palatal Stent
- Keywords
- Free gingival graft, Mucogingival surgery, Periodontal dressing
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ora-Aid-Oral Wound DressingDevice
Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. This product is a non-eugenol protective material applied to intraoral wounds. Ora-Aid is a new concept of pasting intra-oral patch to protect the affected area such as post implant, extraction, orthodontic, and ulcers. This new concept of pasting intra-oral wound dressing is designed to protect the affected area and aid natural healing.
Platelet rich fibrinBiological
It has been reported that the use of Platelet-Rich Fibrin (PRF) to cover palatal wounds accelerates healing and reduces postoperative morbidity. Studies have demonstrated that PRF supports key processes in wound healing, such as "immunity," "angiogenesis," and "cellular proliferation." Its use has garnered significant interest, particularly in non-healing wounds and areas left to heal by secondary intention after surgery. Leukocyte and Platelet-Rich Fibrin (L-PRF) is frequently used in periodontal surgical applications. The platelets and growth factors it contains accelerate the healing process and facilitate tissue repair.
Palatal StentDevice
Palatal stents help prevent complications such as infection or excessive discomfort. These plates are typically customized to fit the patient's palate by taking impressions before the surgery. Once placed, they serve as a barrier, especially during the early stages of healing. Additionally, they may reduce the need for postoperative interventions, such as the use of strong painkillers.
| Study group | Role | What they receive |
|---|---|---|
| Ora-Aid | Experimental | For the test group, Ora-Aid® measuring 25 mm x 15 mm is used. After achieving hemostasis and irrigating the wound area on the palate with sterile saline, Ora-Aid® is cut to appropriate dimensions to fully cover the wound site. Using tweezers, it is separated from its transparent film layer and applied to the wound. Gentle pressure is applied for 5-10 seconds until the dressing adheres to the wound site. To enhance the stabilization of Ora-Aid® in the area, it is secured using 4/0 silk sutures with a cross-suture technique. Receives: Device: Ora-Aid-Oral Wound Dressing |
| L-PRF | Active comparator | For the L-PRF group, venous blood is collected from patients using a disposable sterile syringe and placed into glass tubes without anticoagulants. The blood samples are centrifuged at 2700 rpm for 12 minutes in a centrifuge device. After the centrifugation process is completed, the clot formed in the middle layer of the tube is removed using tweezers and placed between two sterile metal plates to be compressed into a membrane. The dimensions of the obtained L-PRF membrane are adjusted according to the size of the donor site. The wound area on the palate is sutured crosswise using 4/0 silk suture material, and the L-PRF membrane is placed on the wound surface. Receives: Biological: Platelet rich fibrin |
| Palatal Stent | Active comparator | For the palatal stent group, impressions are taken from patients preoperatively, and a plate is prepared. The fit of the plate is checked in the oral cavity. After the free gingival graft is harvested, hemostasis is achieved at the wound site, and the palatal stent is placed on the maxilla. Receives: Device: Palatal Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Patient Satisfaction Data Assessed with the Oral Health Impact Profile-14 (OHIP-14) Questionnaire"
In our study, the OHIP-14 questionnaire was used to evaluate patient satisfaction on postoperative days 3, 7, and 14. The OHIP-14 questionnaire comprises 14 questions (S1-S14) related to functional limitation (S1-S2), physical pain (S3-S4), psychological discomfort (S5-S6), physical disability (S7-S8), psychological disability (S9-S10), social disability (S11-S12), and handicap (S13-S14). Each question was scored on a 5-point Likert scale.
Measured: Postoperative days 3, 7, and 14
Use of Visual Analog Scale (VAS) for Pain Measurements
The Visual Analog Scale (VAS) test is used to measure pain levels in patients on postoperative days 3, 7, and 14. For VAS scoring, patients are asked to mark an integer value between 0 and 10.
Measured: Postoperative days 3, 7, and 14
Secondary outcomes (1)
Hydrogen Peroxide Test for the Presence of Epithelialization
Wound epithelialization is assessed on days 7, 14, and 1 month as "present/absent."
Measured: Postoperative day 7, day 14, and month 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start2 Jan 2025
- Primary completion30 Mar 2025 (estimated)
- Study completion25 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recession, GingivalStudies of the same condition, open and under way.
- 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
- Model description
- After free gingival graft surgery, different materials were applied to aid healing due to the discomfort and pain caused by the wound in the palatal donor site during the postoperative healing process. A total of 36 patients were included in the study and divided into three groups based on the material applied. The test group consisted of "Ora-Aid," while the control groups included L-PRF and the palatal stent group, with 12 patients in each group.In our study, the OHIP-14 questionnaire was used to evaluate patient satisfaction on postoperative days 3, 7, and 14. To measure pain levels on postoperative days 3, 7, and 14, the Visual Analog Scale (VAS) test was used. For VAS scoring, patients were asked to mark an integer value between 0 and 10. Wound epithelialization was assessed on days 7, 14, and 1 month postoperatively as either "present" or "absent."
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sare Eröz, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782035
- Sponsor's protocol ID
- E-61749811-000-3341706
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Periodontal Dressings (Ora-Aid) and Various Materials on the Donor Site's Quality of Life After Free Gingival Graft Surgery
- ClinicalTrials.gov ID
- NCT06782035
- Acronym / sponsor ID
- E-61749811-000-3341706
- Conditions
- Recession, Gingival
- Keywords
- Free gingival graft, Mucogingival surgery, Periodontal dressing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 25 May 2025 (estimated)
- First posted
- 17 Jan 2025 (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.
The inadequate width of attached gingiva, resulting from the loss of the attached gingiva band, is one of the primary mucogingival issues. Free gingival graft (FGG) is a mucogingival surgical technique used to increase the amount of attached gingiva, cover exposed root surfaces in localized gingival recessions, deepen the vestibule, and eliminate frenulum and muscle attachments. The harvested tissue is keratinized attached gingiva. Due to ease of access, the palate is most commonly preferred as the donor site.
Complications that may arise following FGG surgery are generally donor site-related. Reported complications include postoperative bleeding, recurrent herpetic lesions, delayed healing, paresthesia, mucocele, arteriovenous shunt, and postoperative pain. To aid healing and reduce discomfort and pain associated with the wound site in the palate after surgery, various materials have been applied to the donor site to facilitate recovery.
Following FGG surgery, patients will be divided into three groups based on the application of different materials to the wound site in the palate: leukocyte- and platelet-rich fibrin (L-PRF), Ora-Aid oral wound dressing, and a palatal surgical stent. In the Ora-Aid group, after harvesting the graft and placing it in the recipient site, the wound area will be irrigated with saline solution, and Ora-Aid will be trimmed to the appropriate size and shape. It will be gently pressed onto the wound for 5-10 seconds until it adheres. Ora-Aid and L-PRF will be secured to the wound site with a 4/0 silk cross suture. The Ora-Aid application will serve as the test group, the L-PRF application as the positive control group, and the palatal surgical stent as the negative control group. Randomization will be performed using a computer program.
Postoperatively, patients' pain levels will be assessed on the 3rd, 7th, and 14th days using the Visual Analog Scale (VAS) test and the OHIP-14 questionnaire. Wound site epithelialization will be evaluated during follow-up sessions on the 7th and 14th days and at 1 month. After evaluating all questionnaire results, statistical analyses will be conducted.
Detailed description
Clinically, the gingiva is part of the oral mucosa and periodontium that covers the alveolar processes of the jaws and surrounds the cervical portions of the teeth. Topographically, it is divided into free, attached, and interdental gingiva. Following tooth eruption, the gingival margin is located 0.5-2 mm coronally to the cementoenamel junction (CEJ). Histologically, the gingiva consists of epithelium and connective tissue. Anatomically and clinically, it is divided into three distinct regions: free gingiva, interdental gingiva, and attached gingiva.
Mucogingival issues arise as a result of insufficient attached gingiva. A thick keratinized attached gingiva is necessary to protect against masticatory trauma. When attached gingiva is reduced, plaque control becomes difficult, and the area becomes prone to inflammation. For periodontal health, 2 mm of attached gingiva is considered essential. The protective barrier function of attached gingiva prevents free gingival margin movement caused by the effects of perioral muscles in cases of insufficient attached gingiva. Movement of the gingival margin increases the risk of inflammation progression and gingival recession.
Free gingival graft (FGG) is one of the mucogingival surgical procedures used to increase the amount of attached gingiva, cover exposed root surfaces in localized gingival recession, deepen the vestibule, and eliminate frenulum and muscle attachments. The harvested tissue is keratinized attached gingiva. During the FGG procedure, vestibular depth increases, allowing patients to perform brushing more comfortably. The tuberosity region, edentulous alveolar crest, and hard palate are commonly preferred as donor sites due to ease of access.
Post-FGG complications are generally related to the donor site and include postoperative bleeding, recurrent herpetic lesions, delayed healing, paresthesia, mucocele, arteriovenous shunt, and postoperative pain. The palatal donor site often causes more discomfort and pain during the healing process. To support healing, various procedures have been implemented for the palatal donor site, including palatal stent + periodontal dressing application, suturing of hemostatic sponges, and surgical cauterization or laser application.
Recent studies report that Platelet-Rich Fibrin (PRF) accelerates healing and reduces postoperative morbidity when used to cover palatal wounds. Studies have shown that PRF supports "immunity," "angiogenesis," and "cellular proliferation," which play key roles in wound healing. Its use in non-healing wounds and surgical areas left for secondary healing has garnered significant attention. Choukroun developed a method to obtain leukocyte- and platelet-rich fibrin (L-PRF) by centrifuging 9 ml of whole venous blood in non-anticoagulant tubes at 2700 rpm for 12 minutes at room temperature. The process produces three layers within the tube: platelet-poor plasma at the top, red blood cells at the bottom, and L-PRF, a fibrin structure rich in platelets and growth factors, in the middle. The L-PRF layer is extracted with forceps, separated from the red blood cell layer using scissors, and compressed between two metal trays in a sterile container to form a 1-mm-thick membrane for clinical use.
Ora-Aid wound dressing is a relatively new material used for palatal donor site healing following FGG surgery. The adhesive side of Ora-Aid is applied directly to the oral mucosa, forming a protective layer. Ora-Aid offers advantages such as aiding hemostasis, providing physical protection against food particles, bacterial irritants, and smoking, and reducing oral malodor with its natural mint flavor. Another advantage is that it naturally detaches without requiring an additional appointment for removal. Ora-Aid consists of hydrophilic high-density polymers encapsulated within water-insoluble mucoadhesive synthetic cellulose and contains vitamin E, which has wound-healing and hemostatic effects. It is available in two sizes: 50 mm × 20 mm and 25 mm × 15 mm.
After harvesting the FGG, the palatal wound is irrigated with saline solution, and Ora-Aid is trimmed to the appropriate size and shape. It is then peeled from its transparent film and applied to the wound using forceps. The dressing is gently pressed for 5-10 seconds until it adheres to the wound. Ora-Aid use has demonstrated superior results for both patients and clinicians, being effective in reducing postoperative pain and enhancing wound healing. It holds significant potential as a palatal wound dressing material.
The aim of this study is to evaluate the quality of life in patients receiving L-PRF and periodontal dressings on the donor site after free gingival graft surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- After free gingival graft surgery, different materials were applied to aid healing due to the discomfort and pain caused by the wound in the palatal donor site during the postoperative healing process. A total of 36 patients were included in the study and divided into three groups based on the material applied. The test group consisted of "Ora-Aid," while the control groups included L-PRF and the palatal stent group, with 12 patients in each group.In our study, the OHIP-14 questionnaire was used to evaluate patient satisfaction on postoperative days 3, 7, and 14. To measure pain levels on postoperative days 3, 7, and 14, the Visual Analog Scale (VAS) test was used. For VAS scoring, patients were asked to mark an integer value between 0 and 10. Wound epithelialization was assessed on days 7, 14, and 1 month postoperatively as either "present" or "absent."
| Arm | Type | Receives |
|---|---|---|
| Ora-Aid | Experimental | Device: Ora-Aid-Oral Wound DressingFor the test group, Ora-Aid® measuring 25 mm x 15 mm is used. After achieving hemostasis and irrigating the wound area on the palate with sterile saline, Ora-Aid® is cut to appropriate dimensions to fully cover the wound site. Using tweezers, it is separated from its transparent film layer and applied to the wound. Gentle pressure is applied for 5-10 seconds until the dressing adheres to the wound site. To enhance the stabilization of Ora-Aid® in the area, it is secured using 4/0 silk sutures with a cross-suture technique. |
| L-PRF | Active comparator | Biological: Platelet rich fibrinFor the L-PRF group, venous blood is collected from patients using a disposable sterile syringe and placed into glass tubes without anticoagulants. The blood samples are centrifuged at 2700 rpm for 12 minutes in a centrifuge device. After the centrifugation process is completed, the clot formed in the middle layer of the tube is removed using tweezers and placed between two sterile metal plates to be compressed into a membrane. The dimensions of the obtained L-PRF membrane are adjusted according to the size of the donor site. The wound area on the palate is sutured crosswise using 4/0 silk suture material, and the L-PRF membrane is placed on the wound surface. |
| Palatal Stent | Active comparator | Device: Palatal StentFor the palatal stent group, impressions are taken from patients preoperatively, and a plate is prepared. The fit of the plate is checked in the oral cavity. After the free gingival graft is harvested, hemostasis is achieved at the wound site, and the palatal stent is placed on the maxilla. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Systemically healthy Non-smoker Insufficient attached gingiva Not using any medication regularly Age 18-85 years No previous graft taken from the same area Not in pregnancy or lactation period Agreement to participate in the study and sign the "Informed Consent Form"
Key exclusion criteria (1 listed)
- Systemic disease Regular systemic medication use Under 18 years old Pregnant or breastfeeding women Smoker Previous graft taken from the same area
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 |
|---|---|---|
| Ora-Aid-Oral Wound DressingIntended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. This product is a non-eugenol protective material applied to intraoral wounds. Ora-Aid is a new concept of pasting intra-oral patch to protect the affected area such as post implant, extraction, orthodontic, and ulcers. This new concept of pasting intra-oral wound dressing is designed to protect the affected area and aid natural healing. | Device | Ora-Aid |
| Platelet rich fibrinIt has been reported that the use of Platelet-Rich Fibrin (PRF) to cover palatal wounds accelerates healing and reduces postoperative morbidity. Studies have demonstrated that PRF supports key processes in wound healing, such as "immunity," "angiogenesis," and "cellular proliferation." Its use has garnered significant interest, particularly in non-healing wounds and areas left to heal by secondary intention after surgery. Leukocyte and Platelet-Rich Fibrin (L-PRF) is frequently used in periodontal surgical applications. The platelets and growth factors it contains accelerate the healing process and facilitate tissue repair. | Biological | L-PRF |
| Palatal StentPalatal stents help prevent complications such as infection or excessive discomfort. These plates are typically customized to fit the patient's palate by taking impressions before the surgery. Once placed, they serve as a barrier, especially during the early stages of healing. Additionally, they may reduce the need for postoperative interventions, such as the use of strong painkillers. | Device | Palatal Stent |
Primary outcome
"Patient Satisfaction Data Assessed with the Oral Health Impact Profile-14 (OHIP-14) Questionnaire"
Time frame: Postoperative days 3, 7, and 14
In our study, the OHIP-14 questionnaire was used to evaluate patient satisfaction on postoperative days 3, 7, and 14. The OHIP-14 questionnaire comprises 14 questions (S1-S14) related to functional limitation (S1-S2), physical pain (S3-S4), psychological discomfort (S5-S6), physical disability (S7-S8), psychological disability (S9-S10), social disability (S11-S12), and handicap (S13-S14). Each question was scored on a 5-point Likert scale.
Use of Visual Analog Scale (VAS) for Pain Measurements
Time frame: Postoperative days 3, 7, and 14
The Visual Analog Scale (VAS) test is used to measure pain levels in patients on postoperative days 3, 7, and 14. For VAS scoring, patients are asked to mark an integer value between 0 and 10.
1 secondary outcome
Hydrogen Peroxide Test for the Presence of Epithelialization
Time frame: Postoperative day 7, day 14, and month 1.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- 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.
Izmir Katip Celebi University Faculty of Dentistry Department of Periodontology
Izmir, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ora-Aid-Oral Wound Dressing, Platelet rich fibrin and Palatal Stent in people with Recession, Gingival, run by Izmir Katip Celebi 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Patient Satisfaction Data Assessed with the Oral Health Impact Profile-14 (OHIP-14) Questionnaire" (time frame: Postoperative days 3, 7, and 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 17 Jan 2025.