Extraction Socket HealingNCT02707536
Influence of Platelet-Rich Fibrin on Post-extraction Alveolar Ridge Healing/Preservation as a Stand-alone or Adjunct to Particulate Graft
A study testing Socket grafting with PRF and Socket grafting with bone graft in people with Extraction Socket Healing and Alveolar Ridge Preservation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The goal of this project is to evaluate the influence of platelet rich fibrin (PRF) in extraction socket healing with or without particulate bone graft. The hypothesis of this study is that PRF will enhance the extraction socket healing and new bone formation when compared to extraction sockets grafted without PRF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extraction Socket Healing, Alveolar Ridge Preservation
- What is being tested?
- Socket grafting with PRF and Socket grafting with bone graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to May 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects ≥ 18 years of age
- Hopeless or non-restorable single non-molar tooth per quadrant with adjacent teeth present
- Maximum of two teeth can qualify per patient.
- The buccal plate must be ≥ 1mm in width with a 4-wall configuration.
- Cases requiring minimal sinus grafting (<3mm)
- Bone grafting limited to the apical portion of the osteotomy site
Who cannot join
- Untreated periodontal disease, endodontic-periodontal disease and/or caries
- The buccal plate must be ≤ 3mm in width with a 4-wall configuration.
- Patients with uncontrolled or severe systemic disease (Diabetes)
- Patients with medical conditions or taking medication associated with compromised bone healing (Diabetes, Autoimmune Dysfunction, Prolonged Cortisone Therapy, Chemotherapy, or Bisphosphonate Therapy)
- Current Smokers
- Subjects with extensive parafunctional habits (ie; bruxism)
- Subjects who demonstrate inadequate oral hygiene
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston School of Dentistry
Houston, Texas, 77030
About this study
Official title: Influence of Platelet-Rich Fibrin on Post-extraction Alveolar Ridge Healing/Preservation as a Stand-alone or Adjunct to Particulate Graft: A Clinical, Radiographic and Histological Evaluation
The goal of this project is to evaluate the influence of platelet rich fibrin (PRF) in extraction socket healing with or without particulate bone graft. The hypothesis of this study is that PRF will enhance the extraction socket healing and new bone formation when compared to extraction sockets grafted without PRF.
- Being tested
- Socket grafting with PRF, Socket grafting with bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket grafting with PRFProcedure or surgery
Extraction with socket grafting using PRF.
Socket grafting with bone graftProcedure or surgery
Extraction with socket grafting using bone graft.
| Study group | Role | What they receive |
|---|---|---|
| No socket grafting | No intervention | Extraction with normal socket healing |
| Socket grafting with platelet rich fibrin (PRF) alone | Active comparator | Extraction with socket grafting with platelet rich fibrin (PRF) alone. Receives: Procedure: Socket grafting with PRF |
| Socket grafting with bone grafting alone | Active comparator | Extraction with socket grafting using bone graft (xenograft). Receives: Procedure: Socket grafting with bone graft |
| Socket grafting with PRF and bone grafting | Active comparator | Extraction with socket grafting using PRF combined with bone graft (xenograft). Receives: Procedure: Socket grafting with PRF; Procedure: Socket grafting with bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alveolar ridge width (buccal-lingual)
Baseline is at the time of extraction with or without socket grafting.
Measured: baseline, 3 months
Change in alveolar ridge height (apical coronal)
Baseline is at the time of extraction with or without socket grafting.
Measured: baseline, 3 months
Secondary outcomes (2)
Percentage of vital bone in bone core as assessed histology
A bone core will be taken at 3 months after socket grafting.
Measured: 3 months
Percentage of residual bone graft in bone core as assessed histology
A bone core will be taken at 3 months after socket grafting.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startMay 2014
- Primary completionMar 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extraction Socket HealingStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sridhar V. K. Eswaran, The University of Texas Health Science Center, Houston
- Investigators
- Sridhar Eswaran, BDS, MS, MSD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707536
- Sponsor's protocol ID
- HSC-DB-14-0190
- Status last verified
- May 2017
- First submitted
- 9 Mar 2016
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Platelet-Rich Fibrin on Post-extraction Alveolar Ridge Healing/Preservation as a Stand-alone or Adjunct to Particulate Graft: A Clinical, Radiographic and Histological Evaluation
- ClinicalTrials.gov ID
- NCT02707536
- Acronym / sponsor ID
- HSC-DB-14-0190
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 14 Mar 2016 (estimated)
- 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 goal of this project is to evaluate the influence of platelet rich fibrin (PRF) in extraction socket healing with or without particulate bone graft. The hypothesis of this study is that PRF will enhance the extraction socket healing and new bone formation when compared to extraction sockets grafted without PRF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No socket grafting | No intervention | –Extraction with normal socket healing |
| Socket grafting with platelet rich fibrin (PRF) alone | Active comparator | Procedure: Socket grafting with PRFExtraction with socket grafting with platelet rich fibrin (PRF) alone. |
| Socket grafting with bone grafting alone | Active comparator | Procedure: Socket grafting with bone graftExtraction with socket grafting using bone graft (xenograft). |
| Socket grafting with PRF and bone grafting | Active comparator | Procedure: Socket grafting with PRF, Procedure: Socket grafting with bone graftExtraction with socket grafting using PRF combined with bone graft (xenograft). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects ≥ 18 years of age
- Hopeless or non-restorable single non-molar tooth per quadrant with adjacent teeth present
- Maximum of two teeth can qualify per patient.
- The buccal plate must be ≥ 1mm in width with a 4-wall configuration.
- Cases requiring minimal sinus grafting (<3mm)
Key exclusion criteria (7 listed)
- Untreated periodontal disease, endodontic-periodontal disease and/or caries
- The buccal plate must be ≤ 3mm in width with a 4-wall configuration.
- Patients with uncontrolled or severe systemic disease (Diabetes)
- Patients with medical conditions or taking medication associated with compromised bone healing (Diabetes, Autoimmune Dysfunction, Prolonged Cortisone Therapy, Chemotherapy, or Bisphosphonate Therapy)
- Current Smokers
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 grafting with PRFExtraction with socket grafting using PRF. | Procedure or surgery | Socket grafting with PRF and bone grafting, Socket grafting with platelet rich fibrin (PRF) alone |
| Socket grafting with bone graftExtraction with socket grafting using bone graft. | Procedure or surgery | Socket grafting with PRF and bone grafting, Socket grafting with bone grafting alone |
Primary outcome
Change in alveolar ridge width (buccal-lingual)
Time frame: baseline, 3 months
Baseline is at the time of extraction with or without socket grafting.
Change in alveolar ridge height (apical coronal)
Time frame: baseline, 3 months
Baseline is at the time of extraction with or without socket grafting.
2 secondary outcomes
Percentage of vital bone in bone core as assessed histology
Time frame: 3 months
Percentage of residual bone graft in bone core as assessed histology
Time frame: 3 months
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 4 May 2017.
- 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.
Sridhar Eswaran, BDS, MS, MSD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socket grafting with PRF and Socket grafting with bone graft in people with Extraction Socket Healing and Alveolar Ridge Preservation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 4 May 2017. 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 United States. 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?
Change in alveolar ridge width (buccal-lingual) (time frame: baseline, 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.