Postoperative PainNCT03685396
Patient Morbidity After Palatal Free Gingival Grafts With or Without PRF Membranes Coverage
A study testing Platelet rich fibrin ( PRF) and hemostatic agents with oxidized and regenerated cellulosa in people with Postoperative Pain and Postoperative Complications, run by Azienda Ospedaliera San Paolo at 1 site in Italy.
Trial summary
This study evaluates postoperative morbidity of patients that undergo free gingival graft harvesting from palate with or without use of autogenous PRF (Platelet Rich Fibrin) membranes to cover the donor site.In the Test Group venous blood sampling was done in order to prepare PRF membranes used to cover the donor… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Postoperative Complications, Gingival Recession
- What is being tested?
- Platelet rich fibrin ( PRF) and hemostatic agents with oxidized and regenerated cellulosa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 27 Nov 2017to 9 Sep 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- FMPS (Full Mouth Plaque Score) and FMBS (Full Mouth Bleeding Score) < 20%,
- presence of two adjacent Miller's Class I and II recession defects on natural teeth (≥ 2mm in depth);
Who cannot join
- contraindications for periodontal surgery
- taking medications or having diseases known to interfere with periodontal tissue health or healing and coagulation.
- smoking more than 10 cigarettes a day
- Gingival recessions on molar teeth were excluded.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliera San Paolo - Polo Universitario - Università degli Studi di Milano
Milan, Milano, 20142
About this study
Official title: Patient Morbidity After Palatal Free Gingival Grafts With or Without PRF Membranes Coverage: a Comparative Randomized Clinical Trial
This study evaluates postoperative morbidity of patients that undergo free gingival graft harvesting from palate with or without use of autogenous PRF (Platelet Rich Fibrin) membranes to cover the donor site.In the Test Group venous blood sampling was done in order to prepare PRF membranes used to cover the donor site, whereas in Control Group hemostatic agents with oxidized and regenerated cellulosa were used.
- Being tested
- Platelet rich fibrin ( PRF), hemostatic agents with oxidized and regenerated cellulosa
- Keywords
- Connective tissue graft, Platelet concentrates, PRF, Mucogingival surgery
- Medical subject headings
- Pain, Postoperative, Postoperative Complications, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich fibrin ( PRF)Biological
Venous blood was collected with a butterfly needle in two 10 mL tubes without anticoagulants or other chemicals. The tubes were immediately centrifuged at 3000 rpm for 10 minutes.
At the end of centrifugation a fibrin clot (PRF) was obtained in the middle of the tube, just between the red corpuscles at the bottom and acellular plasma at the top. The PRF clot was taken from the tube and the red cells portion at the base of the clot was eliminated with sterile scissors Then the PRF was enveloped in sterile gauzes and positioned between two glass plates: the compression drove out the serum from the clot obtaining PRF membranes that were ready to be used in the surgical site.
hemostatic agents with oxidized and regenerated cellulosaDrug
In the Control Group hemostatic agents with oxidized and regenerated cellulosa were sutured to the palatal wound with mattress suture ( silk 5/0).
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | In the Test Group venous blood sampling was done in order to prepare PRF membranes used to cover the donor site of the connective tissue graft. Receives: Biological: Platelet rich fibrin ( PRF) |
| Control Group | Active comparator | In Control Group hemostatic agents with oxidized and regenerated cellulosa were used to cover the donor site. Receives: Drug: hemostatic agents with oxidized and regenerated cellulosa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pain: VAS
The patient morbidity was evaluated with a questionnaire given to patients 1 week following surgery considering parameters such as post-operative pain, discomfort, bleeding, stress and inability to chew. The questionnaire included the evaluation of the intensity of these parameters on a Visual Analogical Scale (VAS) of 100 mm. Patients had to show their level of pain by indicating a position along a continuous line of 100mm between two end-points. The 0 end-point corresponded to abscence of pain, whereas the end-point at 100mm corresponded to the worst level of pain felt in life. Then the point indicated by the patient was measured in millimeters.
Measured: 2 weeks.
Post-operative Discomfort
Discomfort was defined as the level of soreness experienced by the patients during the first post-operative week due to the palatal wound and how it influenced the ability to work and the quality of the sleep. The questionnaire included the evaluation of the intensity of post-operative discomfort on a Visual Analogical Scale (VAS) of 100 mm. Patients had to show their level of discomfort by indicating a position along a continuous line of 100mm between two end-points. The 0 end-point corresponded to abscence of discomfort whereas the end-point at 100mm corresponded to the worst possible discomfort . Then the point indicated by the patient was measured in millimeters.
Measured: 2 weeks
Post-operative Stress
Stress was related to the level of apprehension and fear experienced by the patients of jeopardizing the palatal wound. The questionnaire included the evaluation of the intensity of post-operative stress on a Visual Analogical Scale (VAS) of 100 mm. Patients had to show their level of stress by indicating a position along a continuous line of 100mm between two end-points. The 0 end-point corresponded to abscence of stress whereas the end-point at 100mm corresponded to the worst possible stress . Then the point indicated by the patient was measured in millimeters.
Measured: 2 weeks
Post-operative Inability to Chew
Inability to chew was described as the level of variation of the patients' eating habits due to the presence of the palatal wound.
The questionnaire included the evaluation of the intensity of post-operative inability to chew on a Visual Analogical Scale (VAS) of 100 mm. Patients had to show their level of inability to chew by indicating a position along a continuous line of 100mm between two end-points. The 0 end-point corresponded to abscence of changes in their eating habits whereas the end-point at 100mm corresponded to the worst possible inability to chew. Then the point indicated by the patient was measured in millimeters.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start27 Nov 2017
- Primary completion23 Jul 2018
- Study completion9 Sep 2018
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 Postoperative PainStudies 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
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Paolo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eliam Scaramuzza, Azienda Ospedaliera San Paolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685396
- Sponsor's protocol ID
- PRF
- Status last verified
- Jun 2019
- First submitted
- 24 Sep 2018
- Last updated
- 5 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Morbidity After Palatal Free Gingival Grafts With or Without PRF Membranes Coverage: a Comparative Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03685396
- Acronym / sponsor ID
- PRF
- Keywords
- Connective tissue graft, Platelet concentrates, PRF, Mucogingival surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Azienda Ospedaliera San PaoloUniversity, hospital or other
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 23 Jul 2018 (actual)
- Study completion
- 9 Sep 2018 (actual)
- First posted
- 26 Sep 2018 (actual)
- Results
- Posted 5 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates postoperative morbidity of patients that undergo free gingival graft harvesting from palate with or without use of autogenous PRF (Platelet Rich Fibrin) membranes to cover the donor site.In the Test Group venous blood sampling was done in order to prepare PRF membranes used to cover the donor site, whereas in Control Group hemostatic agents with oxidized and regenerated cellulosa were used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Biological: Platelet rich fibrin ( PRF)In the Test Group venous blood sampling was done in order to prepare PRF membranes used to cover the donor site of the connective tissue graft. |
| Control Group | Active comparator | Drug: hemostatic agents with oxidized and regenerated cellulosaIn Control Group hemostatic agents with oxidized and regenerated cellulosa were used to cover the donor site. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- FMPS (Full Mouth Plaque Score) and FMBS (Full Mouth Bleeding Score) < 20%,
- presence of two adjacent Miller's Class I and II recession defects on natural teeth (≥ 2mm in depth);
Key exclusion criteria (4 listed)
- contraindications for periodontal surgery
- taking medications or having diseases known to interfere with periodontal tissue health or healing and coagulation.
- smoking more than 10 cigarettes a day
- Gingival recessions on molar teeth were excluded.
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 |
|---|---|---|
| Platelet rich fibrin ( PRF)Venous blood was collected with a butterfly needle in two 10 mL tubes without anticoagulants or other chemicals. The tubes were immediately centrifuged at 3000 rpm for 10 minutes. At the end of centrifugation a fibrin clot (PRF) was obtained in the middle of the tube, just between the red corpuscles at the bottom and acellular plasma at the top. The PRF clot was taken from the tube and the red cells portion at the base of the clot was eliminated with sterile scissors Then the PRF was enveloped in sterile gauzes and positioned between two glass plates: the compression drove out the serum from the clot obtaining PRF membranes that were ready to be used in the surgical site. | Biological | Test Group |
| hemostatic agents with oxidized and regenerated cellulosaIn the Control Group hemostatic agents with oxidized and regenerated cellulosa were sutured to the palatal wound with mattress suture ( silk 5/0). | Drug | Control Group |
Primary outcome
Post-operative Pain: VAS
Time frame: 2 weeks.
The patient morbidity was evaluated with a questionnaire given to patients 1 week following surgery considering parameters such as post-operative pain, discomfort, bleeding, stress and inability to chew. The questionnaire included the evaluation of the intensity of these parameters on a Visual Analogical Scale (VAS) of 100 mm. Patients had to show their level of pain by indicating a position along a continuous line of 100mm between two end-points. The 0 end-point corresponded to abscence of pain, whereas the end-point at 100mm corresponded to the worst level of pain felt in life. Then the point indicated by the patient was measured in millimeters.
Post-operative Discomfort
Time frame: 2 weeks
Discomfort was defined as the level of soreness experienced by the patients during the first post-operative week due to the palatal wound and how it influenced the ability to work and the quality of the sleep. The questionnaire included the evaluation of the intensity of post-operative discomfort on a Visual Analogical Scale (VAS) of 100 mm. Patients had to show their level of discomfort by indicating a position along a continuous line of 100mm between two end-points. The 0 end-point corresponded to abscence of discomfort whereas the end-point at 100mm corresponded to the worst possible discomfort . Then the point indicated by the patient was measured in millimeters.
Post-operative Stress
Time frame: 2 weeks
Stress was related to the level of apprehension and fear experienced by the patients of jeopardizing the palatal wound. The questionnaire included the evaluation of the intensity of post-operative stress on a Visual Analogical Scale (VAS) of 100 mm. Patients had to show their level of stress by indicating a position along a continuous line of 100mm between two end-points. The 0 end-point corresponded to abscence of stress whereas the end-point at 100mm corresponded to the worst possible stress . Then the point indicated by the patient was measured in millimeters.
Post-operative Inability to Chew
Time frame: 2 weeks
Inability to chew was described as the level of variation of the patients' eating habits due to the presence of the palatal wound. The questionnaire included the evaluation of the intensity of post-operative inability to chew on a Visual Analogical Scale (VAS) of 100 mm. Patients had to show their level of inability to chew by indicating a position along a continuous line of 100mm between two end-points. The 0 end-point corresponded to abscence of changes in their eating habits whereas the end-point at 100mm corresponded to the worst possible inability to chew. Then the point indicated by the patient was measured in millimeters.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- 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 Platelet rich fibrin ( PRF) and hemostatic agents with oxidized and regenerated cellulosa in people with Postoperative Pain and Postoperative Complications, run by Azienda Ospedaliera San Paolo at 1 site in Italy.
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 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 5 Aug 2019. 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 Italy. 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 5 Aug 2019). 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?
Post-operative Pain: VAS (time frame: 2 weeks.). The study lists 4 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 5 Aug 2019.