Inadequately Attached Gingiva (Disorder)Phase 1NCT04828720
Assessment of Platelet-Rich Fibrin and Topical Ozonated Oil in the Management of Palatal Wound Healing After Free Gingival Graft Harvest
A Phase 1 study testing ozonated oil in people with Inadequately Attached Gingiva (Disorder), run by Cairo University at 1 site in Egypt.
Trial summary
This randomized clinical trial was conducted to assess the effects of platelets-rich fibrin (PRF) and ozonated oil on the healing of palatal donor wound sites and the patient's morbidity after free gingival graft (FGG) harvesting Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Inadequately Attached Gingiva (Disorder)
- What is being tested?
- ozonated oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 1 Jun 2020
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- (a) age ≥18 years and (b) healthy individuals without any systemic condition that might affect directly on the inflammatory status.
Who cannot join
- (1) patients with coagulation disorders, (2) severe psychiatric disorders, (3) heavy smokers, (4) patients wearing complete or partial denture that had any contact with the palate, (5) lactating or pregnant females and (6) no FGG harvested previously from the site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Cytological Assessment of Platelet-Rich Fibrin and Topical Ozonated Oil in the Management of Palatal Wound Healing After Free Gingival Graft Harvest
This randomized clinical trial was conducted to assess the effects of platelets-rich fibrin (PRF) and ozonated oil on the healing of palatal donor wound sites and the patient's morbidity after free gingival graft (FGG) harvesting
Read the detailed description
Many surgical techniques have been suggested to enhance the width of keratinized tissue either by free gingival grafts (FGGs) or by sub-epithelial connective tissue grafts. FGG is easy to carry out and qualify the harvest of large quantities of connective tissues (CT). Contrariwise, it produces a site of secondary intention wound healing with discomfort and pain. Excessive post-operative morbidity has been reported in the literature as a possible complication of harvesting a FGG; different procedures with primary-intention healing have been proposed to overcome this problem.
The use of a platelet-rich fibrin (PRF) membrane to coat the fresh wound may accelerate the process of healing by providing a more stable rigid fibrin mesh, which is better than a blood clot and supplying a sustained release of growth factors promoting rapid hemostasis at the FGG donor site. PRF is a platelet concentrate obtained by inexpensive and simple procedure that does not need biochemical blood handling, it promotes efficient neovascularization, hastened wound closure and rapid cicatricial tissue remodeling through its three-dimensional fibrin meshwork. PRF owing its energizing effect on wound healing as it provides a superb scaffold for epithelialization and angiogenesis together with the presence of many growth factors such as platelet-derived growth factor (PDGF), epidermal growth factor and fibroblast growth factor (FGF).
Presently, most of researches in dental field using either ozone gas only, dissolved in water (ozonated water) or in plant oils such as olive oil (ozonated oil), focusing on its excellent antimicrobial efficacy, enhancement of wound healing in oral cavity without the possibility of drug resistance.
Oral wound healing is a dynamic process and complex phenomenon involving series overlapping stages of restoring tissue and cellular structures. Cellular and biochemical events in wound healing can be divided into several phases: inflammation, granulation tissue formation, matrix formation, re-epithelialization and tissue remodeling. Epithelial healing or re-epithelialization is an important process that involves the interactions between keratinocytes and extracellular matrix upon which cells migrate, proliferate and differentiate, hence restoring tissue function and structure. The rate of re-epithelization is considered as one of the criteria that reflect the influence of PRF and ozonated oil on healing of wound sites.
- Conditions
- Inadequately Attached Gingiva (Disorder)
- Being tested
- ozonated oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ozonated oilDrug
All patients in ozone group were asked to visit the clinic on a daily basis through the first week and have their allocated therapeutic medication applied to their particular palatal donor site wounds. The wounds were coated with 2 ml ozonated oil per day, with a concentration of 15 µg of ozone/ml of olive oil. Moreover, palatal wounds in control group were managed by compressing the donor site with gauze and periodontal pack was placed. Patients in ozone group used a soft stent to protect the palatal donor wound site and to retain the tested oils in the post harvested palatal wounds. Patients were instructed firmly not to shatter the stent for 1 week. The stent was removed and reseated only by the operator during the application of medications and collection of smears. One week postoperatively, the protective stents were discontinued.
| Study group | Role | What they receive |
|---|---|---|
| PRF group | Active comparator | The PRF was prepared according to Choukroun et al. [5] immediately before surgery, a 10 ml blood sample was taken by venipuncture of the antecubital vein without anticoagulant. The tubes were centrifuged immediately by a dedicated centrifuge at 3,000 rpm for 10 minutes.
A structured fibrin clot was produced by such preparation protocol in the middle of the tube, with the erythrocytes at the bottom and acellular plasma at the top. Following elimination of acellular plasma, a sterile scissors was used to separate the PRF from the erythrocytes. A membrane of PRF was formed by squeezing it gently between two pieces of gauze. Folding of the membrane was performed to achieve the required thickness (1.0 mm) with accurate trimming to match the palatal wound. The obtained membrane was then placed at the palatal donor site and compressed with gauze. Then, it was secured with 3-0 black plaited silk and a stent was placed. Receives: Drug: ozonated oil |
| Control group | Placebo comparator | the palatal wounds in control group were managed by compressing the donor site with gauze and periodontal pack was placed. Patients in control group used a soft stent to protect the palatal donor wound site . Patients were instructed firmly not to shatter the stent for 1 week. The stent was removed and reseated only by the operator during the application of medications and collection of smears. One week postoperatively, the protective stents were discontinued. Receives: Drug: ozonated oil |
| ozonated group | Experimental | the palatal wound in ozanaited group will be painted by ozainated oil 2ml daily for 1 week, Patients used a soft stent to protect the palatal donor wound site . Patients were instructed firmly not to shatter the stent for 1 week. The stent was removed and reseated only by the operator during the application of medications and collection of smears. One week postoperatively, the protective stents were discontinued. Receives: Drug: ozonated oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Healing
The healing assesed by healing index
1- very poor. 5- excellent
Measured: assessed weekly for 1 month
Secondary outcomes (2)
The Pain
assessed by visual analogue scale (VAS)
Measured: after 24 hours and 1 week
cytological analysis
assess the re-epithelization and keratinization rate
Measured: after 7, 14, 21 days and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start1 Oct 2019
- Primary completion1 Apr 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inadequately Attached Gingiva (Disorder)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In patients with inadequate zone of attached gingiva, treatment planned for FGGs to augment keratinized tissue dimensions in the mandibular incisor area.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- October 6 University
- Responsible party
- Principal investigator, Asma Serag, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828720
- Sponsor's protocol ID
- 0000034
- Status last verified
- Apr 2021
- First submitted
- 29 Mar 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Cytological Assessment of Platelet-Rich Fibrin and Topical Ozonated Oil in the Management of Palatal Wound Healing After Free Gingival Graft Harvest
- ClinicalTrials.gov ID
- NCT04828720
- Acronym / sponsor ID
- 0000034
- Conditions
- Inadequately Attached Gingiva (Disorder)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- October 6 University
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 2 Apr 2021 (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.
This randomized clinical trial was conducted to assess the effects of platelets-rich fibrin (PRF) and ozonated oil on the healing of palatal donor wound sites and the patient's morbidity after free gingival graft (FGG) harvesting
Detailed description
Many surgical techniques have been suggested to enhance the width of keratinized tissue either by free gingival grafts (FGGs) or by sub-epithelial connective tissue grafts. FGG is easy to carry out and qualify the harvest of large quantities of connective tissues (CT). Contrariwise, it produces a site of secondary intention wound healing with discomfort and pain. Excessive post-operative morbidity has been reported in the literature as a possible complication of harvesting a FGG; different procedures with primary-intention healing have been proposed to overcome this problem.
The use of a platelet-rich fibrin (PRF) membrane to coat the fresh wound may accelerate the process of healing by providing a more stable rigid fibrin mesh, which is better than a blood clot and supplying a sustained release of growth factors promoting rapid hemostasis at the FGG donor site. PRF is a platelet concentrate obtained by inexpensive and simple procedure that does not need biochemical blood handling, it promotes efficient neovascularization, hastened wound closure and rapid cicatricial tissue remodeling through its three-dimensional fibrin meshwork. PRF owing its energizing effect on wound healing as it provides a superb scaffold for epithelialization and angiogenesis together with the presence of many growth factors such as platelet-derived growth factor (PDGF), epidermal growth factor and fibroblast growth factor (FGF).
Presently, most of researches in dental field using either ozone gas only, dissolved in water (ozonated water) or in plant oils such as olive oil (ozonated oil), focusing on its excellent antimicrobial efficacy, enhancement of wound healing in oral cavity without the possibility of drug resistance.
Oral wound healing is a dynamic process and complex phenomenon involving series overlapping stages of restoring tissue and cellular structures. Cellular and biochemical events in wound healing can be divided into several phases: inflammation, granulation tissue formation, matrix formation, re-epithelialization and tissue remodeling. Epithelial healing or re-epithelialization is an important process that involves the interactions between keratinocytes and extracellular matrix upon which cells migrate, proliferate and differentiate, hence restoring tissue function and structure. The rate of re-epithelization is considered as one of the criteria that reflect the influence of PRF and ozonated oil on healing of wound sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- In patients with inadequate zone of attached gingiva, treatment planned for FGGs to augment keratinized tissue dimensions in the mandibular incisor area.
| Arm | Type | Receives |
|---|---|---|
| PRF group | Active comparator | Drug: ozonated oilThe PRF was prepared according to Choukroun et al. [5] immediately before surgery, a 10 ml blood sample was taken by venipuncture of the antecubital vein without anticoagulant. The tubes were centrifuged immediately by a dedicated centrifuge at 3,000 rpm for 10 minutes. A structured fibrin clot was produced by such preparation protocol in the middle of the tube, with the erythrocytes at the bottom and acellular plasma at the top. Following elimination of acellular plasma, a sterile scissors was used to separate the PRF from the erythrocytes. A membrane of PRF was formed by squeezing it gently between two pieces of gauze. Folding of the membrane was performed to achieve the required thickness (1.0 mm) with accurate trimming to match the palatal wound. The obtained membrane was then placed at the palatal donor site and compressed with gauze. Then, it was secured with 3-0 black plaited silk and a stent was placed. |
| Control group | Placebo comparator | Drug: ozonated oilthe palatal wounds in control group were managed by compressing the donor site with gauze and periodontal pack was placed. Patients in control group used a soft stent to protect the palatal donor wound site . Patients were instructed firmly not to shatter the stent for 1 week. The stent was removed and reseated only by the operator during the application of medications and collection of smears. One week postoperatively, the protective stents were discontinued. |
| ozonated group | Experimental | Drug: ozonated oilthe palatal wound in ozanaited group will be painted by ozainated oil 2ml daily for 1 week, Patients used a soft stent to protect the palatal donor wound site . Patients were instructed firmly not to shatter the stent for 1 week. The stent was removed and reseated only by the operator during the application of medications and collection of smears. One week postoperatively, the protective stents were discontinued. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- (a) age ≥18 years and (b) healthy individuals without any systemic condition that might affect directly on the inflammatory status.
Key exclusion criteria (1 listed)
- (1) patients with coagulation disorders, (2) severe psychiatric disorders, (3) heavy smokers, (4) patients wearing complete or partial denture that had any contact with the palate, (5) lactating or pregnant females and (6) no FGG harvested previously from the site.
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 |
|---|---|---|
| ozonated oilAll patients in ozone group were asked to visit the clinic on a daily basis through the first week and have their allocated therapeutic medication applied to their particular palatal donor site wounds. The wounds were coated with 2 ml ozonated oil per day, with a concentration of 15 µg of ozone/ml of olive oil. Moreover, palatal wounds in control group were managed by compressing the donor site with gauze and periodontal pack was placed. Patients in ozone group used a soft stent to protect the palatal donor wound site and to retain the tested oils in the post harvested palatal wounds. Patients were instructed firmly not to shatter the stent for 1 week. The stent was removed and reseated only by the operator during the application of medications and collection of smears. One week postoperatively, the protective stents were discontinued. | Drug | Control group, PRF group, ozonated group |
Primary outcome
the Healing
Time frame: assessed weekly for 1 month
The healing assesed by healing index 1- very poor. 5- excellent
2 secondary outcomes
The Pain
Time frame: after 24 hours and 1 week
cytological analysis
Time frame: after 7, 14, 21 days and 2 months
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 19 Apr 2021.
- Individual participant dataSharing planned: Undecided
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 Phase 1 study testing ozonated oil in people with Inadequately Attached Gingiva (Disorder), 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 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: finished, as of the sponsor's last update on 19 Apr 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
the Healing (time frame: assessed weekly for 1 month). 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 19 Apr 2021.