Healing Surgical WoundsNCT05375357
Platelet Rich Fibrin in Soft Tissue Healing After Implant Uncovering
A study testing Application of L-PRF on the donor area and Secondary intention healing of the donor area in people with Healing Surgical Wounds, run by G. d'Annunzio University at 1 site in Italy.
Trial summary
This study represents a prospective, controlled and randomized clinical trial assessing the effects of L-PRF on the healing time of the donor area and on the patient's postoperative morbidity in the 4 weeks following the Apically Positioned Flap (APF) procedure in the uncovering phase of two-stage implants. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healing Surgical Wounds
- What is being tested?
- Application of L-PRF on the donor area and Secondary intention healing of the donor area
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 20 Apr 2021to 30 Jul 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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- to have at least one implant in the maxilla with a quantity of vestibular keratinized gingiva < 2 mm
- to be in good systemic health
- to have a good oral hygiene (FMPS and FMBS < 20%)
Who cannot join
- systemic diseases: coagulation disorders; medications affecting periodontal status in the previous 6 months; pregnancy or lactation;
- smoking habits;
- peri-implant surgery on the experimental sites.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Healing Time and Postoperative Morbidity After Implant Uncovering With Vestibularly Repositioned Flap Associated With Leucocyte Platelet Rich Fibrin (L-PRF): a Randomized and Controlled Clinical Trial
This study represents a prospective, controlled and randomized clinical trial assessing the effects of L-PRF on the healing time of the donor area and on the patient's postoperative morbidity in the 4 weeks following the Apically Positioned Flap (APF) procedure in the uncovering phase of two-stage implants.
A total of 40 patients were recruited and divided into two groups. The implant uncovering procedure in the test group was performed with APF and application of L-PRF on the donor area. Patients in the control group, on the other hand, were treated with APF alone, leaving the donor area to heal by secondary intention.
- Conditions
- Healing Surgical Wounds
- Being tested
- Application of L-PRF on the donor area, Secondary intention healing of the donor area
- Keywords
- Platelet Rich Fibrin, Wound Healing, Implant Uncovering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of L-PRF on the donor areaProcedure or surgery
After implant uncovering procedure with apically positioned flap, the donor area is covered with a layer of L-PRF
Secondary intention healing of the donor areaProcedure or surgery
After implant uncovering procedure with apically positioned flap, the donor area is left to heal by secondary intention
| Study group | Role | What they receive |
|---|---|---|
| APF + L-PRF | Experimental | Application of a layer of L-PRF to protect the donor area after uncovering implant procedure using Apically Positioned Flap (APF). Receives: Procedure: Application of L-PRF on the donor area |
| APF without L-PRF | Active comparator | The donor area is left to heal by secondary intention after APF in the implant uncovering procedure. Receives: Procedure: Secondary intention healing of the donor area |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete re-epithelialization of the wound of donor area (CWE)
Time needed to obtain a complete re-epithelialization of the wound of donor area
Measured: 4 weeks
Secondary outcomes (4)
Post-Operative Discomfort (D)
Evaluation of post-operative discomfort using Visual Analogue Scale (VAS).The scale is represented by a straight horizontal line of fixed length, generally 10 cm. Extremities are defined as extreme limits of the parameter to be measured, oriented from left (worst) to right (best).
Measured: 4 weeks
Changes in Feedind Habits (CFH)
Evaluation of changes in patients' feedind habits using Visual Analogue Scale (VAS).The scale is represented by a straight horizontal line of fixed length, generally 10 cm. Extremities are defined as extreme limits of the parameter to be measured, oriented from left (worst) to right (best).
Measured: 4 weeks
Consumption of Analgesics (AU)
Assessment of postoperative pain by the number of analgesics taken
Measured: 4 weeks
Alteration of Sensivity (AS)
Evaluation of alteration of sensivity on donor area
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start20 Apr 2021
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healing Surgical WoundsStudies 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
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Paolantonio, G. d'Annunzio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375357
- Sponsor's protocol ID
- 19102021
- Status last verified
- May 2022
- First submitted
- 10 May 2022
- Last updated
- 19 Dec 2022
- 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 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Healing Time and Postoperative Morbidity After Implant Uncovering With Vestibularly Repositioned Flap Associated With Leucocyte Platelet Rich Fibrin (L-PRF): a Randomized and Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05375357
- Acronym / sponsor ID
- 19102021
- Conditions
- Healing Surgical Wounds
- Keywords
- Platelet Rich Fibrin, Wound Healing, Implant Uncovering
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 16 May 2022 (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 study represents a prospective, controlled and randomized clinical trial assessing the effects of L-PRF on the healing time of the donor area and on the patient's postoperative morbidity in the 4 weeks following the Apically Positioned Flap (APF) procedure in the uncovering phase of two-stage implants.
A total of 40 patients were recruited and divided into two groups. The implant uncovering procedure in the test group was performed with APF and application of L-PRF on the donor area. Patients in the control group, on the other hand, were treated with APF alone, leaving the donor area to heal by secondary intention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APF + L-PRF | Experimental | Procedure: Application of L-PRF on the donor areaApplication of a layer of L-PRF to protect the donor area after uncovering implant procedure using Apically Positioned Flap (APF). |
| APF without L-PRF | Active comparator | Procedure: Secondary intention healing of the donor areaThe donor area is left to heal by secondary intention after APF in the implant uncovering procedure. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- to have at least one implant in the maxilla with a quantity of vestibular keratinized gingiva < 2 mm
- to be in good systemic health
- to have a good oral hygiene (FMPS and FMBS < 20%)
Key exclusion criteria (3 listed)
- systemic diseases: coagulation disorders; medications affecting periodontal status in the previous 6 months; pregnancy or lactation;
- smoking habits;
- peri-implant surgery on the experimental sites.
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 |
|---|---|---|
| Application of L-PRF on the donor areaAfter implant uncovering procedure with apically positioned flap, the donor area is covered with a layer of L-PRF | Procedure or surgery | APF + L-PRF |
| Secondary intention healing of the donor areaAfter implant uncovering procedure with apically positioned flap, the donor area is left to heal by secondary intention | Procedure or surgery | APF without L-PRF |
Primary outcome
Complete re-epithelialization of the wound of donor area (CWE)
Time frame: 4 weeks
Time needed to obtain a complete re-epithelialization of the wound of donor area
4 secondary outcomes
Post-Operative Discomfort (D)
Time frame: 4 weeks
Changes in Feedind Habits (CFH)
Time frame: 4 weeks
Consumption of Analgesics (AU)
Time frame: 4 weeks
Alteration of Sensivity (AS)
Time frame: 4 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 19 Dec 2022.
- 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.
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 Application of L-PRF on the donor area and Secondary intention healing of the donor area in people with Healing Surgical Wounds, run by G. d'Annunzio University 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 3 inclusion and 3 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 Dec 2022. 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?
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?
Complete re-epithelialization of the wound of donor area (CWE) (time frame: 4 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 19 Dec 2022.