Alveolar Socket PreservationNCT06663982
Connective Tissue Graft and Leucocyte - Platelet Rich Fibrin in Alveolar Ridge Preservation
A study testing Connective tissue graft + L-PRF and L-PRF in people with Alveolar Socket Preservation, run by G. d'Annunzio University.
Trial summary
The purpose of our randomized controlled clinical trial is to evaluate radiographic bone dimensional changes and soft tissue healing and thickness after teeth extraction and the implementation of alveolar ridge preservation (RAP) procedures that will involve the application of L-PRF inside the socket in association… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alveolar Socket Preservation
- What is being tested?
- Connective tissue graft + L-PRF and L-PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 9 Dec 2024to 31 Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- Age > 18 years old;
- General good health (ASA I-II);
- Adequate oral hygiene (Full Mouth Plaque Score ≤ 20%, Full Mouth Bleeding Score ≤ 20%);
- Presence of one or more hopeless teeth requiring extraction.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Periosteal Inhibition Technique With Connective Tissue Graft and Leucocyte- Platelet Rich Fibrin in Alveolar Ridge Preservation: a Randomized Controlled Clinical Trial
The purpose of our randomized controlled clinical trial is to evaluate radiographic bone dimensional changes and soft tissue healing and thickness after teeth extraction and the implementation of alveolar ridge preservation (RAP) procedures that will involve the application of L-PRF inside the socket in association with a connective tissue graft (CTG) used as a barrier with the periosteal inhibition technique (PI). The present experimental treatment (test group) will be compared with an active comparator (control group) which will involve the insertion of L-PRF alone inside the socket.
- Conditions
- Alveolar Socket Preservation
- Being tested
- Connective tissue graft + L-PRF, L-PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective tissue graft + L-PRFProcedure or surgery
After administering local anesthesia, an atraumatic extraction will be conducted, preserving the buccal bone and carefully debriding the alveolar socket. Following papilla incisions, an intra-sulcular incision on the vestibular side of the extraction socket will be extended with a #15c scalpel, creating a socket to insert the connective tissue graft (CTG). The CTG will be harvested from the palatal area following a specific incision technique to obtain a graft around 1.5 mm thick, which will be fixed with a mattress suture.
Then the socket will be filled with L-PRF plugs. A collagen sponge will cover the extraction socket and L-PRF, secured with a 4-0 cross suture. Sutures will be removed after 15 days.
L-PRFProcedure or surgery
After administering local anesthesia, an atraumatic extraction will be conducted, preserving the buccal bone and carefully debriding the alveolar socket.
Then the socket will be filled with L-PRF plugs. A collagen sponge will cover the extraction socket and L-PRF, secured with a 4-0 cross suture. Sutures will be removed after 15 days.
| Study group | Role | What they receive |
|---|---|---|
| CTG + L-PRF | Experimental | Not described Receives: Procedure: Connective tissue graft + L-PRF |
| L-PRF | Active comparator | Not described Receives: Procedure: L-PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal Bone Crest
Horizontal width of the alveolar ridge
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start9 Dec 2024 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Socket PreservationStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (estimated)
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
- NCT06663982
- Sponsor's protocol ID
- 27102024
- Status last verified
- Oct 2024
- First submitted
- 27 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- 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 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periosteal Inhibition Technique With Connective Tissue Graft and Leucocyte- Platelet Rich Fibrin in Alveolar Ridge Preservation: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06663982
- Acronym / sponsor ID
- 27102024
- Conditions
- Alveolar Socket Preservation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- 9 Dec 2024 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 29 Oct 2024 (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 purpose of our randomized controlled clinical trial is to evaluate radiographic bone dimensional changes and soft tissue healing and thickness after teeth extraction and the implementation of alveolar ridge preservation (RAP) procedures that will involve the application of L-PRF inside the socket in association with a connective tissue graft (CTG) used as a barrier with the periosteal inhibition technique (PI). The present experimental treatment (test group) will be compared with an active comparator (control group) which will involve the insertion of L-PRF alone inside the socket.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTG + L-PRF | Experimental | Procedure: Connective tissue graft + L-PRF |
| L-PRF | Active comparator | Procedure: L-PRF |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Connective tissue graft + L-PRFAfter administering local anesthesia, an atraumatic extraction will be conducted, preserving the buccal bone and carefully debriding the alveolar socket. Following papilla incisions, an intra-sulcular incision on the vestibular side of the extraction socket will be extended with a #15c scalpel, creating a socket to insert the connective tissue graft (CTG). The CTG will be harvested from the palatal area following a specific incision technique to obtain a graft around 1.5 mm thick, which will be fixed with a mattress suture. Then the socket will be filled with L-PRF plugs. A collagen sponge will cover the extraction socket and L-PRF, secured with a 4-0 cross suture. Sutures will be removed after 15 days. | Procedure or surgery | CTG + L-PRF |
| L-PRFAfter administering local anesthesia, an atraumatic extraction will be conducted, preserving the buccal bone and carefully debriding the alveolar socket. Then the socket will be filled with L-PRF plugs. A collagen sponge will cover the extraction socket and L-PRF, secured with a 4-0 cross suture. Sutures will be removed after 15 days. | Procedure or surgery | L-PRF |
Primary outcome
Horizontal Bone Crest
Time frame: 4 months
Horizontal width of the alveolar ridge
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 29 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes
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Evaluating The Use of CGF Plugs in Fresh Odontectomy Socket.
Odontectomy (Tooth Extraction), Socket Preservation and Healing Following Simple, Non-surgical Extraction
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Efficacy Of Eggshell-Derived Nanohydroxyapatite Based Mineralized Plasmatic Matrix Versus Xenogeneic Based Mineralized Plasmatic Matrix in Posterior Mandibular Socket Preservation
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Socket Shield Technique With CGF and Xenograft for Immediate Implants
Alveolar Bone Loss, Socket Shield Technique
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Immediate Implant Placement Using Socket Shield With CGF
Socket Shield Technique, Concentrated Growth Factors
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.
Questions about this trial
What is this clinical trial studying?
A study testing Connective tissue graft + L-PRF and L-PRF in people with Alveolar Socket Preservation, run by G. d'Annunzio University.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Michele Paolantonio (+39 08713554158, michelepaolantonio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal Bone Crest (time frame: 4 months). 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 29 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.