Chronic PeriodontitisNCT02836314
Clinical and Radiological Effect Of Platelet Rich Fibrin on the Healing of Periodontal Intrabony Periodontal Defects
A study testing Anorganic Bovine Bone Mineral (ABBM) and Anorganic Bovine Bone Mineral and Platelet Rich Fibrin (PRF) in people with Chronic Periodontitis and Intrabony Periodontal Defect, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this split mouth, single-center, controlled study is to compare the healing of intrabony defects treated with a combination of Anorganic Bovine Bone Mineral (ABBM)/Platelet Rich Fibrin (PRF) or Anorganic Bovine Bone Mineral alone. Read more about this study
- Who is it for?
- Ages 38 to 61 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis, Intrabony Periodontal Defect
- What is being tested?
- Anorganic Bovine Bone Mineral (ABBM) and Anorganic Bovine Bone Mineral and Platelet Rich Fibrin (PRF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2011to Dec 2012
- 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 38 to 61 years
- Healthy volunteers accepted
- Adult
Who may be able to join
- no systemic diseases;
- a good level of oral hygiene (OH) (plaque index<0.15);
- presence of two paired two-wall or three-wall intrabony defects with probing depth ≥6mm and an intrabony component ≥3mm as detected on radiographs; -no intrabony defects extending into the furcation area;
- tooth mobility ≤1;
- tooth and adjoining teeth testing vital and without symptoms or signs of endodontic involvement;
- tooth and adjoining teeth free of caries or inadequate restorations.
Who cannot join
- patients with compromised immune systems;
- pregnant and/or lactating women;
- patients taking any drug known to affect the periodontal status or affect the coagulation system
- smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Platelet Rich Fibrin on the Healing of Periodontal Intrabony Defects Treated With Anorganic Bovine Bone Mineral: A Randomized Clinical and Radiological Study
The aim of this split mouth, single-center, controlled study is to compare the healing of intrabony defects treated with a combination of Anorganic Bovine Bone Mineral (ABBM)/Platelet Rich Fibrin (PRF) or Anorganic Bovine Bone Mineral alone. The hypothesis being tested in the study was that PRF would augment the regenerative effects of ABBM in human intrabony defects.
Read the detailed description
Anorganic bovine bone mineral (ABBM) is extensively used in the treatment of intrabony defects. Platelet rich fibrin (PRF) is a new generation platelet concentrate with a simplified technique. Although there are some studies on the use of PRF in the treatment of intrabony defects, to date none of them evaluate its additive effects with ABBM. Therefore, a randomized, split mouth clinical trial was conducted to compare the healing of intrabony defects treated with a PRF/ABBM combination and to those obtained with ABBM alone. Using a split mouth design, 15 paired intrabony defects were randomly treated with either ABBM alone (control group) or with ABBM- PRF combination (test group). The following clinical parameters and radiographic measurements were recorded at baseline and six months postoperatively: plaque index (PI), gingival index (GI), probing depth (PD), gingival recession (GR), clinical attachment level (CAL), vertical bone loss, the depth of the defect and defect angle
- Being tested
- Anorganic Bovine Bone Mineral (ABBM), Anorganic Bovine Bone Mineral and Platelet Rich Fibrin (PRF)
- Keywords
- Anorganic bovine bone mineral;, Graft, Intrabony periodontal defect, platelet rich fibrin
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anorganic Bovine Bone Mineral (ABBM)Other
In the control group, periodontal intrabony defects were treated with ABBM alone.
Anorganic Bovine Bone Mineral and Platelet Rich Fibrin (PRF)Other
In the test group, periodontal intrabony defects were treated with ABBM and PRF combination.
| Study group | Role | What they receive |
|---|---|---|
| PRF and ABBM | Experimental | Intervention: Anorganic Bovine Bone Mineral and Platelet Rich fibrin is applied to the periodontal intrabony defects Receives: Other: Anorganic Bovine Bone Mineral and Platelet Rich Fibrin (PRF) |
| Anorganic Bovine Bone Mineral | Active comparator | Intervention: Anorganic Bovine Bone Mineral is applied to the periodontal intrabony defects Receives: Other: Anorganic Bovine Bone Mineral (ABBM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level change: The distance from cemento-enamel junction to the depth of the sulcus recorded by a periodontal probe at baseline and 6 months postoperatively
Measured: baseline and 6 months
Secondary outcomes (3)
Vertical bone loss change: Distance between cemento-enamel junction and base of the defect measured in standardized radiographs at baseline and 6 months postoperatively
Measured: Baseline and 6 months
Probing depth change: The distance from the gingival margin to the depth of the sulcus recorded by a periodontal probe at baseline and 6 months postoperatively
Measured: baseline and 6 months
Radiographic defect angle change: Using the function 'angle' the defect angle can be measured by assessing the two lines that represent the root surface of the involved tooth and the bone defect surface at baseline and 6 months postoperatively
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies 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, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Yasemin Sezgin, Baskent University
- Investigators
- Levent Taner, PhD, DDS, Study director, Gazi University, Faculty of Dentistry, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836314
- Sponsor's protocol ID
- 03/10-12
- Status last verified
- Jul 2016
- First submitted
- 8 Jul 2016
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Platelet Rich Fibrin on the Healing of Periodontal Intrabony Defects Treated With Anorganic Bovine Bone Mineral: A Randomized Clinical and Radiological Study
- ClinicalTrials.gov ID
- NCT02836314
- Acronym / sponsor ID
- 03/10-12
- Keywords
- Anorganic bovine bone mineral;, Graft, Intrabony periodontal defect, platelet rich fibrin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Jul 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 aim of this split mouth, single-center, controlled study is to compare the healing of intrabony defects treated with a combination of Anorganic Bovine Bone Mineral (ABBM)/Platelet Rich Fibrin (PRF) or Anorganic Bovine Bone Mineral alone. The hypothesis being tested in the study was that PRF would augment the regenerative effects of ABBM in human intrabony defects.
Detailed description
Anorganic bovine bone mineral (ABBM) is extensively used in the treatment of intrabony defects. Platelet rich fibrin (PRF) is a new generation platelet concentrate with a simplified technique. Although there are some studies on the use of PRF in the treatment of intrabony defects, to date none of them evaluate its additive effects with ABBM. Therefore, a randomized, split mouth clinical trial was conducted to compare the healing of intrabony defects treated with a PRF/ABBM combination and to those obtained with ABBM alone. Using a split mouth design, 15 paired intrabony defects were randomly treated with either ABBM alone (control group) or with ABBM- PRF combination (test group). The following clinical parameters and radiographic measurements were recorded at baseline and six months postoperatively: plaque index (PI), gingival index (GI), probing depth (PD), gingival recession (GR), clinical attachment level (CAL), vertical bone loss, the depth of the defect and defect angle
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRF and ABBM | Experimental | Other: Anorganic Bovine Bone Mineral and Platelet Rich Fibrin (PRF)Intervention: Anorganic Bovine Bone Mineral and Platelet Rich fibrin is applied to the periodontal intrabony defects |
| Anorganic Bovine Bone Mineral | Active comparator | Other: Anorganic Bovine Bone Mineral (ABBM)Intervention: Anorganic Bovine Bone Mineral is applied to the periodontal intrabony defects |
Who may qualify
- Ages
- 38 to 61 years
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- no systemic diseases;
- a good level of oral hygiene (OH) (plaque index<0.15);
- presence of two paired two-wall or three-wall intrabony defects with probing depth ≥6mm and an intrabony component ≥3mm as detected on radiographs; -no intrabony defects extending into the furcation area;
- tooth mobility ≤1;
- tooth and adjoining teeth testing vital and without symptoms or signs of endodontic involvement;
Key exclusion criteria (4 listed)
- patients with compromised immune systems;
- pregnant and/or lactating women;
- patients taking any drug known to affect the periodontal status or affect the coagulation system
- 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 |
|---|---|---|
| Anorganic Bovine Bone Mineral (ABBM)In the control group, periodontal intrabony defects were treated with ABBM alone. | Other | Anorganic Bovine Bone Mineral |
| Anorganic Bovine Bone Mineral and Platelet Rich Fibrin (PRF)In the test group, periodontal intrabony defects were treated with ABBM and PRF combination. | Other | PRF and ABBM |
Primary outcome
Clinical attachment level change: The distance from cemento-enamel junction to the depth of the sulcus recorded by a periodontal probe at baseline and 6 months postoperatively
Time frame: baseline and 6 months
3 secondary outcomes
Vertical bone loss change: Distance between cemento-enamel junction and base of the defect measured in standardized radiographs at baseline and 6 months postoperatively
Time frame: Baseline and 6 months
Probing depth change: The distance from the gingival margin to the depth of the sulcus recorded by a periodontal probe at baseline and 6 months postoperatively
Time frame: baseline and 6 months
Radiographic defect angle change: Using the function 'angle' the defect angle can be measured by assessing the two lines that represent the root surface of the involved tooth and the bone defect surface at baseline and 6 months postoperatively
Time frame: baseline and 6 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 19 Jul 2016.
- Individual participant dataSharing planned: Yes
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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.
Levent Taner, PhD, DDS study director
Gazi University, Faculty of Dentistry, Department of Periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anorganic Bovine Bone Mineral (ABBM) and Anorganic Bovine Bone Mineral and Platelet Rich Fibrin (PRF) in people with Chronic Periodontitis and Intrabony Periodontal Defect, run by Baskent University at 1 site in Turkey (Türkiye).
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 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2016. 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 Turkey (Türkiye). 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?
Clinical attachment level change: The distance from cemento-enamel junction to the depth of the sulcus recorded by a periodontal probe at baseline and 6 months postoperatively (time frame: baseline and 6 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 19 Jul 2016.