Alveolar Ridge EnlargementL-PRFNCT05572242
Leukocyte-platelet Rich Fibrin for Alveolar Ridge Preservation
A study testing Premolar extraction and socked preservation with L-PRF and Premolar extraction and socked preservation with Xenogenic bone and collagen membrane. in people with Alveolar Ridge Enlargement, run by Universidad de los Andes, Chile at 1 site in Chile.
Trial summary
After tooth extraction, there is a subsequent bone loss as a part of the natural healing of the tissue. Up to 50% of bone loss occurs during the first three months after extraction, jeopardizing a possible implant treatment. Alveolar ridge preservation techniques reduce bone loss, allowing a future implant treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Enlargement
- What is being tested?
- Premolar extraction and socked preservation with L-PRF and Premolar extraction and socked preservation with Xenogenic bone and collagen membrane.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChile
- Study dates
- 1 Nov 2022to Mar 2025
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Periodontally healthy individuals with at least 18 years of age
- Good oral hygiene (BOP \& Pl ≤ 20%)
- Patients with a single failing premolar in the maxilla and mandible.
- With or without buccal plate after tooth extraction (similar cases in both groups)
- Surrounded by a mesial and distal natural tooth
- Capability to comply with the study procedures
- Informed Consent as documented by signature
Who cannot join
- Pregnant or lactating women
- Known or suspected non-compliance, drug or alcohol abuse
- Smokers (>10 cigarettes/day)
- Systemic or local conditions presenting a contraindication to implant treatment
- Currently taking drugs that influence bone metabolism
- Use of bisphosphonates in the last 4 years
- History of malignancy, radiotherapy or chemotherapy for malignancy in the past 5 years
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Centro de Salud, Universidad de los Andes
Santiago, Santiago Metropolitan, 8050000
Guillermo Salgado, DDS, PhD, 56225891171, gsalgado@uandes.cl
About this study
Official title: Autologous Leukocyte-platelet Rich Fibrin (L-PRF) Versus a Xenogeneic Bone Substitute Combined With a Collagen Matrix for Alveolar Ridge Preservation. A Randomized Controlled Clinical Trial
After tooth extraction, there is a subsequent bone loss as a part of the natural healing of the tissue. Up to 50% of bone loss occurs during the first three months after extraction, jeopardizing a possible implant treatment. Alveolar ridge preservation techniques reduce bone loss, allowing a future implant treatment. Different bone filling materials have been used with good clinical results. The second-generation platelet concentrates (L-PRF) have recently been shown to induce bone regeneration when filling the socket after extraction, with significant biological and economic advantages. The hypothesis of this study is to test whether or not the use of L-PRF in alveolar ridge preservation results in a non-inferior horizontal radiographic change compared with the combination of a xenogeneic bone substitute with a collagen matrix.
Read the detailed description
This study is a non inferiority clinical controlled trial of parallel groups. Study Intervention and Indication
After single premolar extractions in the maxilla or mandible area, patients will be randomly allocated to either one of the two treatment modalities:
- Alveolar ridge preservation using L-PRF (test)
- Alveolar ridge preservation using xenogeneic bone covered with a collagen matrix (control)
Study objectives Primary Objective The present study aims to test whether or not the use of L-PRF in alveolar ridge preservation results in non-inferior horizontal ridge width changes measured at - 1 mm below the most coronal aspect of the alveolar crest compared to the combination of a xenogeneic bone substitute material with a collagen matrix, 4 months after tooth extraction.
Clinical procedures
Extraction surgery
Partially edentulous patients in need of a single-tooth extraction in the premolar region (maxilla or mandible), with two neighboring natural teeth, will be included. All surgical procedures will be performed under local anesthesia. After disinfection of the surgical site with 0.2% chlorhexidine solution (PerioAid® Treatment, Barcelona, Spain), local anesthetics (Lidocaine HCl 2% with epinephrine 1:100,000; XXX) will be administered by infiltration at the respective buccal and lingual sites at maxilla or inferior alveolar nerve block technique on the mandible. The tooth will be luxated first with straight and angled elevators and then carefully extracted with forceps without raising a flap. After that, patients will be randomly assigned to either one of the two treatment modalities:
- Alveolar ridge preservation with leukocyte-platelet rich fibrin (L-PRF) (test)
- Alveolar ridge preservation using xenogeneic bone covered with a collagen matrix (DBBM+CM) (control)
Clinical procedures A venepuncture will be performed before any surgery (irrespective of the later randomization). Six plastic sterile 9 mL tubes without anticoagulant will be drawn with venous blood from the median basilica vein, median cubital vein, or median cephalic vein. Preparation of the L-PRF clots and membranes will be performed as previously described. In brief, within 60 seconds after the blood draws, the tubes will be centrifuged at 408 g RCF for 12 min using a tabletop centrifuge (IntraSpinTM, IntraLock®, Florida, USA). Following centrifugation, L-PRF clots will be removed from the tube, separated from the remaining red thrombus at the base with tweezers, and gently compressed into membranes using a metal rack and a metal plate.
Extraction surgery
Partially edentulous patients needing a single-tooth extraction in the premolar region (maxilla or mandible), with two neighboring natural teeth, will be included in the study. All surgical procedures will be performed under local anesthesia. After disinfection of the surgical site with 0.2% chlorhexidine solution (PerioAid® Treatment, Barcelona, Spain), local anesthetics (Lidocaine HCl 2% with epinephrine 1:100,000; XXX) will be administered by infiltration at the respective buccal and lingual sites at maxilla or inferior alveolar nerve block technique on the mandible. The tooth will be luxated first with straight and angled elevators and then carefully extracted with forceps without raising a flap. After that, patients will be randomly assigned to either one of the two treatment modalities:
- Alveolar ridge preservation with leukocyte-platelet rich fibrin (L-PRF) (test)
- Alveolar ridge preservation using xenogeneic bone covered with a collagen matrix (DBBM+CM) (control)
In group L-PRF group, 2-5 PRF clots, depending on the size of the socket, will be inserted and compressed with a large plunger until they reach the alveolar crest as previously described (Temmerman et al., 2016). The site will thereafter be covered with 2-3 L-PRF membranes. Then, crossed horizontal mattress suture will be placed, followed by single interrupted sutures for better stabilization (Vicryl 4.0 EthiconTM, Johnsson \& Johnsson, New Jersey, New York, USA). No efforts will be undertaken to obtain primary wound closure. The grafted socket will be left to heal for 4 months.
In group DBBM+CM, the socket will be grafted with xenogeneic bone substitute material (up to the palatal/lingual bone crest) and covered with a collagen matrix. Single interrupted sutures (Vicryl 4.0 EthiconTM, Johnsson \& Johnsson, New Jersey, New York, USA) will be placed to stabilize the collagen matrix. Sutures will be removed within 7-10 days. The grafted socket will then be left to heal for 4 months.
The xenogenic material DBBM will be Bio-Oss Collagen®, and collagen matrix Bio-Gide® both delivered as the Combi-Kit Collagen (Geistlich Pharma AG - Switzerland).
Immediately after surgery, despite the treatment group, the patient will be scanned using a CBCT (cone beam computed tomography)
Implant surgery
At 4 months, patients from both groups will be recalled for implant placement. Before the surgery, a CBCT and an impression will be taken. Moreover, clinical data will be recorded. Upon local anesthesia, a full flap will be raised, and a biopsy will be taken in the center of the implant site using a trephine drill (inner diameter 2mm). Thereafter, the implant will be placed according to the manufacturer's recommendation. A submerged healing protocol will be allowed. Final reconstructions will be inserted 4 months later.
- Type of implants: Biohorizons 3.8 * 10.5 mm as a standard implant, inserted at bone level.
- Healing mode: Submerged
- No provisional reconstruction
- Type of final reconstruction: Cad-cam screw-retained and axis screw, depending on the case.
Follow-up examinations Follow-up examinations will be performed at baseline 2 (10 days after crown insertion), 6 months, and 1 year after final restoration.
- Conditions
- Alveolar Ridge Enlargement
- Being tested
- Premolar extraction and socked preservation with L-PRF, Premolar extraction and socked preservation with Xenogenic bone and collagen membrane.
- Keywords
- tooth extraction, socket graft, L-PRF, xenogenic bone, dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Premolar extraction and socked preservation with L-PRFProcedure or surgery
Partially edentulous patients in need of a single-tooth extraction in the premolar region[ (maxilla or mandible), with two neighboring natural teeth, will be included in the study. The tooth will be luxated first with elevators and then carefully extracted with forceps without raising a flap.
L-PRF group will use 2-5 PRF clots, depending on the size of the socket, which will be inserted and compressed with a large plunger until they reach the alveolar crest. The site will thereafter be covered with L-PRF membranes. Then, crossed horizontal mattress suture will be placed followed by single interrupted sutures for stabilization. No efforts will be undertaken to obtain primary wound closure. The grafted socket will be left to heal for 4 months.
After 4 months of socket preservation, a dental implant will be inserted into the socket. After 4 months of implant healing, a cad cam final restoration will be delivered. The follow-up will be up to 12 months after the final restoration.
Premolar extraction and socked preservation with Xenogenic bone and collagen membrane.Procedure or surgery
Partially edentulous patients in need of a single-tooth extraction in the premolar region (maxilla or mandible), with two neighboring natural teeth, will be included in the study. The tooth will be luxated first with straight and angled elevators and then carefully extracted with forceps without raising a flap.
In the control group, the socket will be grafted with xenogeneic bone substitute material (up to the palatal/lingual bone crest) and covered with a collagen matrix. Single interrupted sutures will be placed to stabilize the collagen matrix. Sutures will be removed at 7-10 days. The grafted socket will then be left to heal for a period of 4 months.
The xenogenic material will be Bio-Oss Collagen® and collagen matrix Bio-Gide® .
After 4 months of socket preservation, a dental implant will be placed. After 4 months of implant healing, a cad cam final restoration will be delivered. The follow-up will be up to 12 months after the final restoration.
| Study group | Role | What they receive |
|---|---|---|
| L-PRF preservation (test) | Experimental | Using L-PRF membranes inside the socket, covering with L-PRF membranes, (test group). Receives: Procedure: Premolar extraction and socked preservation with L-PRF |
| Xenogenic bone plus collagen membrane (control) | Active comparator | Bio-Oss® Collagen at the bone level and application of a collagen matrix (Combi-Kit). Both materials will be used for socket preservation (control). Receives: Procedure: Premolar extraction and socked preservation with Xenogenic bone and collagen membrane. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone socket horizontal and vertical changes evaluated using cbct ((cone beam computed tomography)
Cone-beam computed tomographic (CBCT) imaging will be used to assess the primary outcome (horizontal radiographic changes at -1 mm below the alveolar crest) in both groups between baseline 1 (immediately post socket preservation), visit 4 (4 months after socket preservation), and 12 months after implant rehabilitation. Linear measurements will be performed. The most apical point of the extraction socket will be defined, and two reference lines will be subsequently drawn. The vertical reference line will be drawn in the center of the extraction socket crossing the apical reference point. A horizontal reference line will be drawn perpendicular to the vertical line crossing the apical reference point. Based on these reference lines, the horizontal ridge width will then be measured at -1 mm below the alveolar crest (HW-1). The same procedure will be applied for assessing the horizontal ridge width changes will then be measured at -3 mm (HW-3) and 5- mm (HW-5) below the alveolar crest.
Measured: first cbct immediately after socket preservation surgery, second cbct 4 months after surgery, 12 months after the final restoration of the implant.
Secondary outcomes (11)
Mucosal height
Mucosa height measured in millimeters from the implant platform until the mucosal margin using a North Carolina periodontal probe
Measured: 4 months after implant insertion, at the final restoration delivery
Peri-implant Keratinized Mucosa
keratinized mucosal height measured in millimeters from the implant mucosal vestibular margin until the mucogingival junction using a North Carolina periodontal probe
Measured: 10 days, 6, and 12 months after final restoration
Bleeding on probing
The presence or absence (dichotomic) of bleeding around the peri-implant sulcus after a gentle probing using a North Carolina periodontal probe
Measured: 10 days, 6, and 12 months after final restoration
Probing depth
Probing depth of the peri-implant sulcus measured in millimeters at six points around de implant (3 points on the vestibular and 3 points on the lingual side) using a North Carolina periodontal probe
Measured: 10 days, 6, and 12 months after final restoration
Profilometric Changes
Profilometric changes, measured by the digitalization of stone cast obtained from de patient. The measurements will be at 1 and 3 mm below the preoperative mucosa margin.
Measured: at baseline (socket preservation), 4 months (implant insertion), 10 days and 12 months after final restoration delivery
Phenotype
Phenotype will be assessed by using a periodontal probe. If the probe results still visible after its insertion in the keratinized mucosa, the phenotype will be considered thin; if not, the phenotype will be classified as thick.
Measured: 10 days, 6 and 12 months after final restoration
Pink esthetic score (PES)
measured at 7 sites (mesial, distal papilla, soft tissue level, soft tissue contour, bone contour, color and texture of the soft tissue) under visual examination, using 3 scores per site (0: absence, 1: partial presence, 2: full presence) with a maximum of 14 points
Measured: 10 days, 6, and 12 months after final restoration
White esthetic score (WES)
based on tooth form, contour, color, texture, and translucence, under visual examination, using 3 scores per site (0: absence, 1: partial presence, 2: full presence) with a maximum of 14 points
Measured: 10 days, 6, and 12 months after final restoration
Visual analog scale for pain assessment (VAS)
Ten degrees of pain are used, 0 no pain, 10 the worst pain imaginable. The patient will select a degree under his perception
Measured: Pain perceived, 24 hrs after socket preservation and implant insertion (4 months).
Oral Health Impact Profile (OHIP-14)
self-filled questionnaire that focuses on seven dimensions of impact (functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability and handicap). Patients will be asked to respond according to frequency of impact on a 5-point Likert scale coded never (score 0), hardly ever (score 1), occasionally (score2), fairly often (score 3) and very often (score 4) using a twelve-months recall period.
The OHIP-14 scores can range from 0 to 56 and are calculated by summing the ordinal values for the 14 items. Higher OHIP-14 scores indicate worse and lower scores indicate better Oral Health Related Quality of Life.
Measured: at baseline, 6 and 12 months after final restoration
Radiographic evaluation
Intraoral calibrated X-rays images will be taken. The digitally obtained x-rays will be transferred into a software program and the pitch distance between two implant threads will be used for calibration. The marginal bone levels (MBL) will be then assessed at the mesial and distal aspects of each implant by measuring the distance between the implant shoulder and the bone crest. Thereafter, mean values will be calculated for all implants and for both groups.
Measured: 10 days, 6, and 12 months after final restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start1 Nov 2022
- Primary completionOct 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge EnlargementStudies 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
- This study is a non-inferiority clinical controlled trial of parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de los Andes, Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Geistlich Pharma AG, BioHorizons, Inc.
- Responsible party
- Principal investigator, Antonio Sanz, Universidad de los Andes, Chile
- Investigators
- Antonio Sanz, DDS, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572242
- Sponsor's protocol ID
- CPI-ODO:16
- Acronym
- L-PRF
- Status last verified
- Jan 2023
- First submitted
- 3 May 2022
- Last updated
- 5 Jan 2023
- 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 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Leukocyte-platelet Rich Fibrin (L-PRF) Versus a Xenogeneic Bone Substitute Combined With a Collagen Matrix for Alveolar Ridge Preservation. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05572242
- Acronym / sponsor ID
- L-PRF / CPI-ODO:16
- Conditions
- Alveolar Ridge Enlargement
- Keywords
- tooth extraction, socket graft, L-PRF, xenogenic bone, dental implant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Universidad de los Andes, ChileUniversity, hospital or other
- Collaborators
- Geistlich Pharma AG, BioHorizons, Inc.
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 7 Oct 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.
After tooth extraction, there is a subsequent bone loss as a part of the natural healing of the tissue. Up to 50% of bone loss occurs during the first three months after extraction, jeopardizing a possible implant treatment. Alveolar ridge preservation techniques reduce bone loss, allowing a future implant treatment. Different bone filling materials have been used with good clinical results. The second-generation platelet concentrates (L-PRF) have recently been shown to induce bone regeneration when filling the socket after extraction, with significant biological and economic advantages. The hypothesis of this study is to test whether or not the use of L-PRF in alveolar ridge preservation results in a non-inferior horizontal radiographic change compared with the combination of a xenogeneic bone substitute with a collagen matrix.
Detailed description
This study is a non inferiority clinical controlled trial of parallel groups. Study Intervention and Indication
After single premolar extractions in the maxilla or mandible area, patients will be randomly allocated to either one of the two treatment modalities:
- Alveolar ridge preservation using L-PRF (test)
- Alveolar ridge preservation using xenogeneic bone covered with a collagen matrix (control)
Study objectives Primary Objective The present study aims to test whether or not the use of L-PRF in alveolar ridge preservation results in non-inferior horizontal ridge width changes measured at - 1 mm below the most coronal aspect of the alveolar crest compared to the combination of a xenogeneic bone substitute material with a collagen matrix, 4 months after tooth extraction.
Clinical procedures
Extraction surgery
Partially edentulous patients in need of a single-tooth extraction in the premolar region (maxilla or mandible), with two neighboring natural teeth, will be included. All surgical procedures will be performed under local anesthesia. After disinfection of the surgical site with 0.2% chlorhexidine solution (PerioAid® Treatment, Barcelona, Spain), local anesthetics (Lidocaine HCl 2% with epinephrine 1:100,000; XXX) will be administered by infiltration at the respective buccal and lingual sites at maxilla or inferior alveolar nerve block technique on the mandible. The tooth will be luxated first with straight and angled elevators and then carefully extracted with forceps without raising a flap. After that, patients will be randomly assigned to either one of the two treatment modalities:
- Alveolar ridge preservation with leukocyte-platelet rich fibrin (L-PRF) (test)
- Alveolar ridge preservation using xenogeneic bone covered with a collagen matrix (DBBM+CM) (control)
Clinical procedures A venepuncture will be performed before any surgery (irrespective of the later randomization). Six plastic sterile 9 mL tubes without anticoagulant will be drawn with venous blood from the median basilica vein, median cubital vein, or median cephalic vein. Preparation of the L-PRF clots and membranes will be performed as previously described. In brief, within 60 seconds after the blood draws, the tubes will be centrifuged at 408 g RCF for 12 min using a tabletop centrifuge (IntraSpinTM, IntraLock®, Florida, USA). Following centrifugation, L-PRF clots will be removed from the tube, separated from the remaining red thrombus at the base with tweezers, and gently compressed into membranes using a metal rack and a metal plate.
Extraction surgery
Partially edentulous patients needing a single-tooth extraction in the premolar region (maxilla or mandible), with two neighboring natural teeth, will be included in the study. All surgical procedures will be performed under local anesthesia. After disinfection of the surgical site with 0.2% chlorhexidine solution (PerioAid® Treatment, Barcelona, Spain), local anesthetics (Lidocaine HCl 2% with epinephrine 1:100,000; XXX) will be administered by infiltration at the respective buccal and lingual sites at maxilla or inferior alveolar nerve block technique on the mandible. The tooth will be luxated first with straight and angled elevators and then carefully extracted with forceps without raising a flap. After that, patients will be randomly assigned to either one of the two treatment modalities:
- Alveolar ridge preservation with leukocyte-platelet rich fibrin (L-PRF) (test)
- Alveolar ridge preservation using xenogeneic bone covered with a collagen matrix (DBBM+CM) (control)
In group L-PRF group, 2-5 PRF clots, depending on the size of the socket, will be inserted and compressed with a large plunger until they reach the alveolar crest as previously described (Temmerman et al., 2016). The site will thereafter be covered with 2-3 L-PRF membranes. Then, crossed horizontal mattress suture will be placed, followed by single interrupted sutures for better stabilization (Vicryl 4.0 EthiconTM, Johnsson \& Johnsson, New Jersey, New York, USA). No efforts will be undertaken to obtain primary wound closure. The grafted socket will be left to heal for 4 months.
In group DBBM+CM, the socket will be grafted with xenogeneic bone substitute material (up to the palatal/lingual bone crest) and covered with a collagen matrix. Single interrupted sutures (Vicryl 4.0 EthiconTM, Johnsson \& Johnsson, New Jersey, New York, USA) will be placed to stabilize the collagen matrix. Sutures will be removed within 7-10 days. The grafted socket will then be left to heal for 4 months.
The xenogenic material DBBM will be Bio-Oss Collagen®, and collagen matrix Bio-Gide® both delivered as the Combi-Kit Collagen (Geistlich Pharma AG - Switzerland).
Immediately after surgery, despite the treatment group, the patient will be scanned using a CBCT (cone beam computed tomography)
Implant surgery
At 4 months, patients from both groups will be recalled for implant placement. Before the surgery, a CBCT and an impression will be taken. Moreover, clinical data will be recorded. Upon local anesthesia, a full flap will be raised, and a biopsy will be taken in the center of the implant site using a trephine drill (inner diameter 2mm). Thereafter, the implant will be placed according to the manufacturer's recommendation. A submerged healing protocol will be allowed. Final reconstructions will be inserted 4 months later.
- Type of implants: Biohorizons 3.8 * 10.5 mm as a standard implant, inserted at bone level.
- Healing mode: Submerged
- No provisional reconstruction
- Type of final reconstruction: Cad-cam screw-retained and axis screw, depending on the case.
Follow-up examinations Follow-up examinations will be performed at baseline 2 (10 days after crown insertion), 6 months, and 1 year after final restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a non-inferiority clinical controlled trial of parallel groups
| Arm | Type | Receives |
|---|---|---|
| L-PRF preservation (test) | Experimental | Procedure: Premolar extraction and socked preservation with L-PRFUsing L-PRF membranes inside the socket, covering with L-PRF membranes, (test group). |
| Xenogenic bone plus collagen membrane (control) | Active comparator | Procedure: Premolar extraction and socked preservation with Xenogenic bone and collagen membrane.Bio-Oss® Collagen at the bone level and application of a collagen matrix (Combi-Kit). Both materials will be used for socket preservation (control). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Periodontally healthy individuals with at least 18 years of age
- Good oral hygiene (BOP \& Pl ≤ 20%)
- Patients with a single failing premolar in the maxilla and mandible.
- With or without buccal plate after tooth extraction (similar cases in both groups)
- Surrounded by a mesial and distal natural tooth
Key exclusion criteria (7 listed)
- Pregnant or lactating women
- Known or suspected non-compliance, drug or alcohol abuse
- Smokers (>10 cigarettes/day)
- Systemic or local conditions presenting a contraindication to implant treatment
- Currently taking drugs that influence bone metabolism
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 |
|---|---|---|
| Premolar extraction and socked preservation with L-PRFPartially edentulous patients in need of a single-tooth extraction in the premolar region[ (maxilla or mandible), with two neighboring natural teeth, will be included in the study. The tooth will be luxated first with elevators and then carefully extracted with forceps without raising a flap. L-PRF group will use 2-5 PRF clots, depending on the size of the socket, which will be inserted and compressed with a large plunger until they reach the alveolar crest. The site will thereafter be covered with L-PRF membranes. Then, crossed horizontal mattress suture will be placed followed by single interrupted sutures for stabilization. No efforts will be undertaken to obtain primary wound closure. The grafted socket will be left to heal for 4 months. After 4 months of socket preservation, a dental implant will be inserted into the socket. After 4 months of implant healing, a cad cam final restoration will be delivered. The follow-up will be up to 12 months after the final restoration. | Procedure or surgery | L-PRF preservation (test) |
| Premolar extraction and socked preservation with Xenogenic bone and collagen membrane.Partially edentulous patients in need of a single-tooth extraction in the premolar region (maxilla or mandible), with two neighboring natural teeth, will be included in the study. The tooth will be luxated first with straight and angled elevators and then carefully extracted with forceps without raising a flap. In the control group, the socket will be grafted with xenogeneic bone substitute material (up to the palatal/lingual bone crest) and covered with a collagen matrix. Single interrupted sutures will be placed to stabilize the collagen matrix. Sutures will be removed at 7-10 days. The grafted socket will then be left to heal for a period of 4 months. The xenogenic material will be Bio-Oss Collagen® and collagen matrix Bio-Gide® . After 4 months of socket preservation, a dental implant will be placed. After 4 months of implant healing, a cad cam final restoration will be delivered. The follow-up will be up to 12 months after the final restoration. | Procedure or surgery | Xenogenic bone plus collagen membrane (control) |
Primary outcome
Bone socket horizontal and vertical changes evaluated using cbct ((cone beam computed tomography)
Time frame: first cbct immediately after socket preservation surgery, second cbct 4 months after surgery, 12 months after the final restoration of the implant.
Cone-beam computed tomographic (CBCT) imaging will be used to assess the primary outcome (horizontal radiographic changes at -1 mm below the alveolar crest) in both groups between baseline 1 (immediately post socket preservation), visit 4 (4 months after socket preservation), and 12 months after implant rehabilitation. Linear measurements will be performed. The most apical point of the extraction socket will be defined, and two reference lines will be subsequently drawn. The vertical reference line will be drawn in the center of the extraction socket crossing the apical reference point. A horizontal reference line will be drawn perpendicular to the vertical line crossing the apical reference point. Based on these reference lines, the horizontal ridge width will then be measured at -1 mm below the alveolar crest (HW-1). The same procedure will be applied for assessing the horizontal ridge width changes will then be measured at -3 mm (HW-3) and 5- mm (HW-5) below the alveolar crest.
11 secondary outcomes
Mucosal height
Time frame: 4 months after implant insertion, at the final restoration delivery
Peri-implant Keratinized Mucosa
Time frame: 10 days, 6, and 12 months after final restoration
Bleeding on probing
Time frame: 10 days, 6, and 12 months after final restoration
Probing depth
Time frame: 10 days, 6, and 12 months after final restoration
Profilometric Changes
Time frame: at baseline (socket preservation), 4 months (implant insertion), 10 days and 12 months after final restoration delivery
Phenotype
Time frame: 10 days, 6 and 12 months after final restoration
Pink esthetic score (PES)
Time frame: 10 days, 6, and 12 months after final restoration
White esthetic score (WES)
Time frame: 10 days, 6, and 12 months after final restoration
Visual analog scale for pain assessment (VAS)
Time frame: Pain perceived, 24 hrs after socket preservation and implant insertion (4 months).
Oral Health Impact Profile (OHIP-14)
Time frame: at baseline, 6 and 12 months after final restoration
Radiographic evaluation
Time frame: 10 days, 6, and 12 months after final restoration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- 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.
Antonio Sanz, DDS principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Premolar extraction and socked preservation with L-PRF and Premolar extraction and socked preservation with Xenogenic bone and collagen membrane. in people with Alveolar Ridge Enlargement, run by Universidad de los Andes, Chile at 1 site in Chile.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 Jan 2023. 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 Chile. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Sanz, DDS (56226181372, asanz@clinicasanz.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone socket horizontal and vertical changes evaluated using cbct ((cone beam computed tomography) (time frame: first cbct immediately after socket preservation surgery, second cbct 4 months after surgery, 12 months after the final restoration of the implant.). 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 Jan 2023.