Alveolar Ridge AugmentationNCT05005377
Peri-Implant Soft and Hard Tissue Stability Following Socket Preservation
A study testing Socket Preservation with Platelet-Rich Fibrin and Socket Preservation with Freeze-Dried Bone Allograft in people with Alveolar Ridge Augmentation and Bone Transplantation, run by Tehran University of Medical Sciences.
Trial summary
The viability of Platelet Rich Fibrin (PRF) on enhancement of osseous and associated tissue healing has been substantiated well in literature. This study aimed to assess peri-implant soft and hard tissue changes after prosthetic loading of implants following socket preservation with platelet-rich fibrin (PRF) and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Augmentation, Bone Transplantation
- What is being tested?
- Socket Preservation with Platelet-Rich Fibrin and Socket Preservation with Freeze-Dried Bone Allograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 1 Mar 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age, who were referred for extraction of the hopeless teeth. The reasons for tooth extraction included root fracture, failed root canal therapy, and extensive non-restorable caries.
Who cannot join
- a history of systemic disease and head/neck radiotherapy, use of drugs affecting bone metabolism, smoking more than 10 cigarettes per day, the presence of significant periapical or periodontal lesions around the respective teeth, and the presence of dehiscence or fenestration larger than 3mm in the buccal bone plate.
About this study
Official title: Peri-Implant Soft and Hard Tissue Stability After Loading of Implants Following Socket Preservation With Platelet-Rich Fibrin and Freeze-Dried Bone Allograft
The viability of Platelet Rich Fibrin (PRF) on enhancement of osseous and associated tissue healing has been substantiated well in literature. This study aimed to assess peri-implant soft and hard tissue changes after prosthetic loading of implants following socket preservation with platelet-rich fibrin (PRF) and freeze-dried bone allograft (FDBA) in a 12-month period.
This Study evaluated 48 patients who were randomly divided into two groups for anterior ridge preservation with PRF and FDBA. At 12 months after implant placement and prosthetic delivery, bone loss was evaluated radiographically while soft tissue changes were evaluated by measuring gingival recession, papilla index, and bleeding on probing (BOP). The differences between the PRF and FDBA groups were analyzed using Fisher's exact test and student's t-test (P<0.05).
Read the detailed description
This study was conducted on 48 patients over 18 years of age (average age of 38 years). The patients required single-rooted incisor/premolar teeth extraction with a hopeless prognosis; for whom, socket preservation with PRF or FDBA was later performed. The reasons for tooth extraction included root fracture, failed root canal therapy, and extensive non-restorable caries. The ethics and study design was approved the Research Ethics Committee of Tehran University of Medical Sciences (IR.TUMS.DENTISTRY.REC.1396.2610) and conducted in accordance with the Declaration of Helsinki. All patients signed an informed consent prior to enrollment. They were free to leave the study at any time and ensured about the confidentiality of their information. The exclusion criteria included a history of systemic disease and head/neck radiotherapy, use of drugs affecting bone metabolism, smoking more than 10 cigarettes per day, the presence of significant periapical or periodontal lesions around the respective teeth, and the presence of dehiscence or fenestration larger than 3mm in the buccal bone plate. After extraction of the teeth, the patients underwent socket preservation with the use of PRF or FDBA. 4 months later, they received a Zimmer ScrewVent bone-level implant (Zimmer, Biomet, USA) which was left in place for 2 to 4 month (mandible and maxilla respectively) to achieve proper osseointegration. All implants were successfully osseointegrated. 10 patients were excluded during the study due to poor cooperation in the follow-up period. Eventually, 38 patients including 23 females and 15 males were subjected to hard and soft tissue assessments at 6 and 12 months, postoperatively. Patients in the PRF group included 9 males and 9 females (a total of 18) with a mean age of 30.81 years (ranging from 21 to 50 years). Patients in the FDBA group included 6 males and 14 females (a total of 20) with a mean age of 37.25 years (ranging from 22 to 50 years).
In second-stage surgery, a full-thickness flap was elevated and a gingival former (Zimmer, Biomet, USA) matching the fixture size placed. Soft tissue healing around the gingival former was allowed for 3 weeks and then a fixture level impression made using the closed-tray impression technique by additional silicone (Panasil, Kettenbach GmbH \& Co. KG, Eschenburg). The master cast was poured with G-mask SnowRock (Velmix; MungyoGroup, Korea) and Moldano dental stone (Tara, Iran). All selected abutments were straight, with a 0.5 mm gingival height. If the gingival height around an implant was variable, the higher value was chosen and other surfaces of the abutment were prepared such that the final finish line was positioned 0.5 mm subgingivally. After abutment preparation, a metal framework was waxed-up for a cement-retained metal-ceramic crown using resin pattern (GC Corporation, USA). The framework was then cast (Wirobond® C, Bego, USA) and tried in the second session. Vita Classic Shade Guide (Vitapan, Germany) was used to select the tooth shade. Porcelain adjustments (VITA VM ceramic, VITA Zahnfabrik, Germany) including the contacts, occlusion, contour and the esthetic appearance of the crown was performed at the third session. The crowns were then glazed. In the fourth prosthetic session, the abutments were tighten to 25 N.Cm final torque and sealed with a Teflon band. The glazed crown was cemented with temporary cement (TempBond, Kerr) and excess cement thoroughly removed. Complete seating of the crown and excess cement removal were ensured in the first radiograph.
To assess the hard tissue stability around each implant, a digital radiograph (Digora Optime, Acteon, India) was obtained with a size 2 sensor using a film holder (Kerr). All baseline and follow-up radiographs were parallel and exposure settings were the same for each patient in the baseline and follow-up radiographs. Using Scanora software (SCANORA lite, Soredex, Helsinki, Finland), the distance from the crestal bone-fixture interface to the abutment-crown interface (crown margin) was measured at the mesial and distal surfaces of the implant at 0, 6 and 12 months after implant placement (Fig1).These measurements were repeated 3 times at the mesial and 3 times at the distal surfaces for each patient and the mean values reported to minimize the errors. To assess soft tissue changes, clinical gingival parameters including the gingival recession (defined as the change in the distance from the gingival margin to the crown margin compared with time 0), the papilla index (distance from the tip of the papilla to the crown margin in the mesial and distal surfaces) (Fig2), and bleeding on probing (BOP) at the mesiobuccal and distobuccal points were measured at 0, 6 and 12 months, postoperatively.
Data were analyzed using SPSS version 22. Qualitative variables were compared using Fisher's exact test while quantitative variables were compared using unpaired student's t-test. The level of significance was set at 0.05.
- Conditions
- Alveolar Ridge Augmentation, Bone Transplantation
- Being tested
- Socket Preservation with Platelet-Rich Fibrin, Socket Preservation with Freeze-Dried Bone Allograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket Preservation with Platelet-Rich FibrinProcedure or surgery
10cc of blood was drawn from each patient and centrifuged at 2700 revolutions per minute (rpm) for 12 minutes to obtain PRF. The extraction socket was filled with PRF and covered using a membrane made of PRF.
Socket Preservation with Freeze-Dried Bone AllograftProcedure or surgery
The extraction socket was filled with FDBA (CenoBone®; Tissue Regeneration Corp., Kish Island, Iran) without flap elevation. The socket was covered using a free palatal mucosal graft obtained by the pouch technique.
| Study group | Role | What they receive |
|---|---|---|
| Socket Preservation with Platelet-Rich Fibrin | Experimental | 10cc of blood was drawn from each patient and centrifuged at 2700 revolutions per minute (rpm) for 12 minutes to obtain PRF. The extraction socket was filled with PRF and covered using a membrane made of PRF. Receives: Procedure: Socket Preservation with Platelet-Rich Fibrin |
| Socket Preservation with Freeze-Dried Bone Allograft | Experimental | the extraction socket was filled with FDBA (CenoBone®; Tissue Regeneration Corp., Kish Island, Iran) without flap elevation. The socket was covered using a free palatal mucosal graft obtained by the pouch technique. Receives: Procedure: Socket Preservation with Freeze-Dried Bone Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean vertical ridge resorption
Mean bone loss around implants measured using Scanora software (SCANORA lite, Soredex, Helsinki, Finland), the distance from the crestal bone-fixture interface to the abutment-crown interface (crown margin) was measured at the mesial and distal surfaces of the implant immediately after implant placement. These measurements were repeated 3 times at the mesial and 3 times at the distal surfaces for each patient and the mean values reported to minimize the errors.
Measured: 0 month
mean vertical ridge resorption
Mean bone loss around implants measured using Scanora software (SCANORA lite, Soredex, Helsinki, Finland), the distance from the crestal bone-fixture interface to the abutment-crown interface (crown margin) was measured at the mesial and distal surfaces of the implant 6 months after implant placement. These measurements were repeated 3 times at the mesial and 3 times at the distal surfaces for each patient and the mean values reported to minimize the errors.
Measured: 6 month
mean vertical ridge resorption
Mean bone loss around implants measured using Scanora software (SCANORA lite, Soredex, Helsinki, Finland), the distance from the crestal bone-fixture interface to the abutment-crown interface (crown margin) was measured at the mesial and distal surfaces of the implant 12 months after implant placement. These measurements were repeated 3 times at the mesial and 3 times at the distal surfaces for each patient and the mean values reported to minimize the errors.
Measured: 12 month
Mean Gingival Recession
gingival recession was defined as the changes in the distance from the gingival margin to the crown margin )
Measured: 0 month
Mean Gingival Recession
gingival recession was defined as the changes in the distance from the gingival margin to the crown margin compared with time 0)
Measured: 6 month
Mean Gingival Recession
gingival recession was defined as the changes in the distance from the gingival margin to the crown margin compared with time 0)
Measured: 12 month
Changes in Papilla Index
it was measured via the distance from the tip of the papilla to the crown margin in the mesial and distal surfaces of the restoration
Measured: 0 month
Changes in Papilla Index
it was measured via the distance from the tip of the papilla to the crown margin in the mesial and distal surfaces of the restoration
Measured: 6 month
Changes in Papilla Index
it was measured via the distance from the tip of the papilla to the crown margin in the mesial and distal surfaces of the restoration
Measured: 12 month
Frequency of bleeding on probing
was measured at the mesiobuccal and distobuccal points of the restoration
Measured: 0 month
Frequency of bleeding on probing
was measured at the mesiobuccal and distobuccal points of the restoration
Measured: 6 month
Frequency of bleeding on probing
was measured at the mesiobuccal and distobuccal points of the restoration
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start1 Dec 2016
- Primary completion1 Dec 2018
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alveolar Ridge AugmentationStudies 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
- 48 patients were randomly divided into two groups for anterior ridge preservation with PRF and FDBA. At 12 months after implant placement and prosthetic delivery, bone loss was evaluated radiographically while soft tissue changes were evaluated by measuring gingival recession, papilla index, and bleeding on probing (BOP).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005377
- Sponsor's protocol ID
- 1396.261
- Status last verified
- Jul 2021
- First submitted
- 15 Jul 2021
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Azangookhiavi H, Habibzadeh S, Zahmatkesh H, Mellati E, Mosaddad SA, Dadpour Y. The effect of platelet-rich fibrin (PRF) versus freeze-dried bone allograft (FDBA) used in alveolar ridge preservation on the peri-implant soft and hard tissues: a randomized clinical trial. BMC Oral Health. 2024 Jun 14;24(1):693. doi: 10.1186/s12903-024-04478-1.
PubMed 38877446
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-Implant Soft and Hard Tissue Stability After Loading of Implants Following Socket Preservation With Platelet-Rich Fibrin and Freeze-Dried Bone Allograft
- ClinicalTrials.gov ID
- NCT05005377
- Acronym / sponsor ID
- 1396.261
- Conditions
- Alveolar Ridge Augmentation, Bone Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 13 Aug 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.
The viability of Platelet Rich Fibrin (PRF) on enhancement of osseous and associated tissue healing has been substantiated well in literature. This study aimed to assess peri-implant soft and hard tissue changes after prosthetic loading of implants following socket preservation with platelet-rich fibrin (PRF) and freeze-dried bone allograft (FDBA) in a 12-month period.
This Study evaluated 48 patients who were randomly divided into two groups for anterior ridge preservation with PRF and FDBA. At 12 months after implant placement and prosthetic delivery, bone loss was evaluated radiographically while soft tissue changes were evaluated by measuring gingival recession, papilla index, and bleeding on probing (BOP). The differences between the PRF and FDBA groups were analyzed using Fisher's exact test and student's t-test (P<0.05).
Detailed description
This study was conducted on 48 patients over 18 years of age (average age of 38 years). The patients required single-rooted incisor/premolar teeth extraction with a hopeless prognosis; for whom, socket preservation with PRF or FDBA was later performed. The reasons for tooth extraction included root fracture, failed root canal therapy, and extensive non-restorable caries. The ethics and study design was approved the Research Ethics Committee of Tehran University of Medical Sciences (IR.TUMS.DENTISTRY.REC.1396.2610) and conducted in accordance with the Declaration of Helsinki. All patients signed an informed consent prior to enrollment. They were free to leave the study at any time and ensured about the confidentiality of their information. The exclusion criteria included a history of systemic disease and head/neck radiotherapy, use of drugs affecting bone metabolism, smoking more than 10 cigarettes per day, the presence of significant periapical or periodontal lesions around the respective teeth, and the presence of dehiscence or fenestration larger than 3mm in the buccal bone plate. After extraction of the teeth, the patients underwent socket preservation with the use of PRF or FDBA. 4 months later, they received a Zimmer ScrewVent bone-level implant (Zimmer, Biomet, USA) which was left in place for 2 to 4 month (mandible and maxilla respectively) to achieve proper osseointegration. All implants were successfully osseointegrated. 10 patients were excluded during the study due to poor cooperation in the follow-up period. Eventually, 38 patients including 23 females and 15 males were subjected to hard and soft tissue assessments at 6 and 12 months, postoperatively. Patients in the PRF group included 9 males and 9 females (a total of 18) with a mean age of 30.81 years (ranging from 21 to 50 years). Patients in the FDBA group included 6 males and 14 females (a total of 20) with a mean age of 37.25 years (ranging from 22 to 50 years).
In second-stage surgery, a full-thickness flap was elevated and a gingival former (Zimmer, Biomet, USA) matching the fixture size placed. Soft tissue healing around the gingival former was allowed for 3 weeks and then a fixture level impression made using the closed-tray impression technique by additional silicone (Panasil, Kettenbach GmbH \& Co. KG, Eschenburg). The master cast was poured with G-mask SnowRock (Velmix; MungyoGroup, Korea) and Moldano dental stone (Tara, Iran). All selected abutments were straight, with a 0.5 mm gingival height. If the gingival height around an implant was variable, the higher value was chosen and other surfaces of the abutment were prepared such that the final finish line was positioned 0.5 mm subgingivally. After abutment preparation, a metal framework was waxed-up for a cement-retained metal-ceramic crown using resin pattern (GC Corporation, USA). The framework was then cast (Wirobond® C, Bego, USA) and tried in the second session. Vita Classic Shade Guide (Vitapan, Germany) was used to select the tooth shade. Porcelain adjustments (VITA VM ceramic, VITA Zahnfabrik, Germany) including the contacts, occlusion, contour and the esthetic appearance of the crown was performed at the third session. The crowns were then glazed. In the fourth prosthetic session, the abutments were tighten to 25 N.Cm final torque and sealed with a Teflon band. The glazed crown was cemented with temporary cement (TempBond, Kerr) and excess cement thoroughly removed. Complete seating of the crown and excess cement removal were ensured in the first radiograph.
To assess the hard tissue stability around each implant, a digital radiograph (Digora Optime, Acteon, India) was obtained with a size 2 sensor using a film holder (Kerr). All baseline and follow-up radiographs were parallel and exposure settings were the same for each patient in the baseline and follow-up radiographs. Using Scanora software (SCANORA lite, Soredex, Helsinki, Finland), the distance from the crestal bone-fixture interface to the abutment-crown interface (crown margin) was measured at the mesial and distal surfaces of the implant at 0, 6 and 12 months after implant placement (Fig1).These measurements were repeated 3 times at the mesial and 3 times at the distal surfaces for each patient and the mean values reported to minimize the errors. To assess soft tissue changes, clinical gingival parameters including the gingival recession (defined as the change in the distance from the gingival margin to the crown margin compared with time 0), the papilla index (distance from the tip of the papilla to the crown margin in the mesial and distal surfaces) (Fig2), and bleeding on probing (BOP) at the mesiobuccal and distobuccal points were measured at 0, 6 and 12 months, postoperatively.
Data were analyzed using SPSS version 22. Qualitative variables were compared using Fisher's exact test while quantitative variables were compared using unpaired student's t-test. The level of significance was set at 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 48 patients were randomly divided into two groups for anterior ridge preservation with PRF and FDBA. At 12 months after implant placement and prosthetic delivery, bone loss was evaluated radiographically while soft tissue changes were evaluated by measuring gingival recession, papilla index, and bleeding on probing (BOP).
| Arm | Type | Receives |
|---|---|---|
| Socket Preservation with Platelet-Rich Fibrin | Experimental | Procedure: Socket Preservation with Platelet-Rich Fibrin10cc of blood was drawn from each patient and centrifuged at 2700 revolutions per minute (rpm) for 12 minutes to obtain PRF. The extraction socket was filled with PRF and covered using a membrane made of PRF. |
| Socket Preservation with Freeze-Dried Bone Allograft | Experimental | Procedure: Socket Preservation with Freeze-Dried Bone Allograftthe extraction socket was filled with FDBA (CenoBone®; Tissue Regeneration Corp., Kish Island, Iran) without flap elevation. The socket was covered using a free palatal mucosal graft obtained by the pouch technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years of age, who were referred for extraction of the hopeless teeth. The reasons for tooth extraction included root fracture, failed root canal therapy, and extensive non-restorable caries.
Key exclusion criteria (1 listed)
- a history of systemic disease and head/neck radiotherapy, use of drugs affecting bone metabolism, smoking more than 10 cigarettes per day, the presence of significant periapical or periodontal lesions around the respective teeth, and the presence of dehiscence or fenestration larger than 3mm in the buccal bone plate.
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 |
|---|---|---|
| Socket Preservation with Platelet-Rich Fibrin10cc of blood was drawn from each patient and centrifuged at 2700 revolutions per minute (rpm) for 12 minutes to obtain PRF. The extraction socket was filled with PRF and covered using a membrane made of PRF. | Procedure or surgery | Socket Preservation with Platelet-Rich Fibrin |
| Socket Preservation with Freeze-Dried Bone AllograftThe extraction socket was filled with FDBA (CenoBone®; Tissue Regeneration Corp., Kish Island, Iran) without flap elevation. The socket was covered using a free palatal mucosal graft obtained by the pouch technique. | Procedure or surgery | Socket Preservation with Freeze-Dried Bone Allograft |
Primary outcome
mean vertical ridge resorption
Time frame: 0 month
Mean bone loss around implants measured using Scanora software (SCANORA lite, Soredex, Helsinki, Finland), the distance from the crestal bone-fixture interface to the abutment-crown interface (crown margin) was measured at the mesial and distal surfaces of the implant immediately after implant placement. These measurements were repeated 3 times at the mesial and 3 times at the distal surfaces for each patient and the mean values reported to minimize the errors.
mean vertical ridge resorption
Time frame: 6 month
Mean bone loss around implants measured using Scanora software (SCANORA lite, Soredex, Helsinki, Finland), the distance from the crestal bone-fixture interface to the abutment-crown interface (crown margin) was measured at the mesial and distal surfaces of the implant 6 months after implant placement. These measurements were repeated 3 times at the mesial and 3 times at the distal surfaces for each patient and the mean values reported to minimize the errors.
mean vertical ridge resorption
Time frame: 12 month
Mean bone loss around implants measured using Scanora software (SCANORA lite, Soredex, Helsinki, Finland), the distance from the crestal bone-fixture interface to the abutment-crown interface (crown margin) was measured at the mesial and distal surfaces of the implant 12 months after implant placement. These measurements were repeated 3 times at the mesial and 3 times at the distal surfaces for each patient and the mean values reported to minimize the errors.
Mean Gingival Recession
Time frame: 0 month
gingival recession was defined as the changes in the distance from the gingival margin to the crown margin )
Mean Gingival Recession
Time frame: 6 month
gingival recession was defined as the changes in the distance from the gingival margin to the crown margin compared with time 0)
Mean Gingival Recession
Time frame: 12 month
gingival recession was defined as the changes in the distance from the gingival margin to the crown margin compared with time 0)
Changes in Papilla Index
Time frame: 0 month
it was measured via the distance from the tip of the papilla to the crown margin in the mesial and distal surfaces of the restoration
Changes in Papilla Index
Time frame: 6 month
it was measured via the distance from the tip of the papilla to the crown margin in the mesial and distal surfaces of the restoration
Changes in Papilla Index
Time frame: 12 month
it was measured via the distance from the tip of the papilla to the crown margin in the mesial and distal surfaces of the restoration
Frequency of bleeding on probing
Time frame: 0 month
was measured at the mesiobuccal and distobuccal points of the restoration
Frequency of bleeding on probing
Time frame: 6 month
was measured at the mesiobuccal and distobuccal points of the restoration
Frequency of bleeding on probing
Time frame: 12 month
was measured at the mesiobuccal and distobuccal points of the restoration
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 13 Aug 2021.
- Derived from this study: PubMed 38877446Azangookhiavi H, Habibzadeh S, Zahmatkesh H, Mellati E, Mosaddad SA, Dadpour Y. The effect of platelet-rich fibrin (PRF) versus freeze-dried bone allograft (FDBA) used in alveolar ridge preservation on the peri-implant soft and hard tissues: a randomized clinical trial. BMC Oral Health. 2024 Jun 14;24(1):693. doi: 10.1186/s12903-024-04478-1.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Socket Preservation with Platelet-Rich Fibrin and Socket Preservation with Freeze-Dried Bone Allograft in people with Alveolar Ridge Augmentation and Bone Transplantation, run by Tehran University of Medical Sciences.
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 13 Aug 2021. 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?
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?
mean vertical ridge resorption (time frame: 0 month). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05005377, which also lists 1 linked publication.
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 13 Aug 2021.