Periodontal Bone LossPhase 4NCT02218515
Treatment of Intrabony Periodontal Defects With Enamel Matrix Derivatives and Autogenous Bone Graft
A Phase 4 study testing Open Flap Debridement, EmdogainⓇ(Enamel Matrix Derivative) and EmdogainⓇEnamel Matrix Derivative+Autogenous Bone in people with Periodontal Bone Loss and Chronic Periodontitis, run by Haner Direskeneli, Prof at 1 site in Turkey (Türkiye).
Trial summary
The present study aimed to evaluate the effects of enamel matrix derivatives either alone or combined with autogenous bone graft applied to intrabony defects in chronic periodontitis patients on clinical/radiographic parameters and gingival crevicular fluid transforming growth factor-β1 level and, to compare with open… Read more about this study
- Who is it for?
- Ages 32 to 57 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Bone Loss, Chronic Periodontitis
- What is being tested?
- Open Flap Debridement, EmdogainⓇ(Enamel Matrix Derivative) and EmdogainⓇEnamel Matrix Derivative+Autogenous Bone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2010to Sep 2012
- Phase
- Phase 4
- 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 32 to 57 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- no systemic diseases as diabetes mellitus or cardiovascular diseases that contraindicated periodontal surgery and could influence the outcome of the therapy; (b) no smoking (c) no medications affecting periodontal tissues; (d) no pregnancy or lactation; (e) a good level of oral hygiene (plaque index < 1, and full mouth bleeding on probing score <20% after initial periodontal treatment), (f) compliance with the maintenance programme and (g) presence of at least one intra-bony defect with a probing depth ≥6 mm, radiographic depth of the defect ≥3 mm as detected on the radiographs.
Who cannot join
- pregnancy or lactating, (b) required an antibiotic premedication, (c) received antibiotic treatment in the previous 6 months, (d) smokers, (e) whose tooth had inadequate amount of attached keratinized gingiva (<1mm)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Faculty of Dentistry, Department of Periodontology
Istanbul, Şişli/Nişantaşı, 34365
About this study
Official title: Evaluation of Gingival Crevicular Fluid Transforming Growth Factor-β1 Level After Treatment of Intrabony Periodontal Defects With Enamel Matrix Derivatives and Autogenous Bone Graft
The present study aimed to evaluate the effects of enamel matrix derivatives either alone or combined with autogenous bone graft applied to intrabony defects in chronic periodontitis patients on clinical/radiographic parameters and gingival crevicular fluid transforming growth factor-β1 level and, to compare with open flap debridement. Our hypothesis is to test whether the use of autogenous bone graft and enamel matrix derivative combination in the treatment of intrabony periodontal defects enhance the clinical, radiographic and biochemical parameters in comparison to the use of open flap debridement alone.
Read the detailed description
The present study aimed to evaluate the effects of enamel matrix derivatives (EMD) either alone or combined with autogenous bone graft (ABG) applied to intrabony defects in chronic periodontitis patients on clinical/radiographic parameters and gingival crevicular fluid (GCF) transforming growth factor-β1 (TGF-β1) level and, to compare with open flap debridement (OFD). A total of 30 deep intrabony defects in 12 patients were randomly treated with EMD+ABG (Combination group), EMD alone (EMD group) or OFD (Control group). Clinical parameters including plaque index, gingival index, bleeding on probing, probing depth, relative attachment level and recession were recorded at baseline and 6 months post-surgery. Intrabony defect fill percentage was calculated on the standardized radiographs. TGF-β1 level was evaluated in GCF just before surgery and 7, 14, 30, 90, 180 days after surgery using ELISA.
- Conditions
- Periodontal Bone Loss, Chronic Periodontitis
- Being tested
- Open Flap Debridement, EmdogainⓇ(Enamel Matrix Derivative), EmdogainⓇEnamel Matrix Derivative+Autogenous Bone
- Keywords
- Autogenous bone graft, Chronic periodontitis, Enamel matrix derivatives, Gingival crevicular fluid, Periodontal flap surgery
- Medical subject headings
- Alveolar Bone Loss, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Flap DebridementProcedure or surgery
Open Flap Debridement (Control Group)
EmdogainⓇ(Enamel Matrix Derivative)Biological
Open Flap Debridement+Enamel Matrix Derivative
EmdogainⓇEnamel Matrix Derivative+Autogenous BoneBiological
Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)+Autogenous Bone
| Study group | Role | What they receive |
|---|---|---|
| Open Flap Debridement | Other | Open Flap Debridement (Control Group) Receives: Procedure: Open Flap Debridement |
| Enamel Matrix Derivative | Experimental | Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative) Receives: Biological: EmdogainⓇ(Enamel Matrix Derivative) |
| Enamel Matrix Derivative+Autogenous Bone | Experimental | Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)+Autogenous Bone Receives: Biological: EmdogainⓇEnamel Matrix Derivative+Autogenous Bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attachment Gain
Measured: 6 months after surgery
Secondary outcomes (1)
Gingival crevicular fluid TGF-β1 level
Measured: 1 week, 2 weeks, 4 weeks, 12 weeks and 72 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startSep 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal Bone LossStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haner Direskeneli, Prof
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haner Direskeneli, Prof, Marmara University
- Investigators
- Ömer Birkan Ağralı, Dr., Principal investigator, Marmara University Faculty of Dentistry, Department of PeriodontologyBahar Kuru, Prof. Dr., Study chair, Marmara University, Faculty of Dentistry, Department of PeriodontologyLeyla Kuru, Prof. Dr., Study director, Marmara University, Faculty of Dentistry, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218515
- Sponsor's protocol ID
- SAG-C-DRP-090909-0288
- Status last verified
- Aug 2014
- First submitted
- 11 Aug 2014
- Last updated
- 18 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gingival Crevicular Fluid Transforming Growth Factor-β1 Level After Treatment of Intrabony Periodontal Defects With Enamel Matrix Derivatives and Autogenous Bone Graft
- ClinicalTrials.gov ID
- NCT02218515
- Acronym / sponsor ID
- SAG-C-DRP-090909-0288
- Conditions
- Periodontal Bone Loss, Chronic Periodontitis
- Keywords
- Autogenous bone graft, Chronic periodontitis, Enamel matrix derivatives, Gingival crevicular fluid, Periodontal flap surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Haner Direskeneli, ProfUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 18 Aug 2014 (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 present study aimed to evaluate the effects of enamel matrix derivatives either alone or combined with autogenous bone graft applied to intrabony defects in chronic periodontitis patients on clinical/radiographic parameters and gingival crevicular fluid transforming growth factor-β1 level and, to compare with open flap debridement. Our hypothesis is to test whether the use of autogenous bone graft and enamel matrix derivative combination in the treatment of intrabony periodontal defects enhance the clinical, radiographic and biochemical parameters in comparison to the use of open flap debridement alone.
Detailed description
The present study aimed to evaluate the effects of enamel matrix derivatives (EMD) either alone or combined with autogenous bone graft (ABG) applied to intrabony defects in chronic periodontitis patients on clinical/radiographic parameters and gingival crevicular fluid (GCF) transforming growth factor-β1 (TGF-β1) level and, to compare with open flap debridement (OFD). A total of 30 deep intrabony defects in 12 patients were randomly treated with EMD+ABG (Combination group), EMD alone (EMD group) or OFD (Control group). Clinical parameters including plaque index, gingival index, bleeding on probing, probing depth, relative attachment level and recession were recorded at baseline and 6 months post-surgery. Intrabony defect fill percentage was calculated on the standardized radiographs. TGF-β1 level was evaluated in GCF just before surgery and 7, 14, 30, 90, 180 days after surgery using ELISA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open Flap Debridement | Other | Procedure: Open Flap DebridementOpen Flap Debridement (Control Group) |
| Enamel Matrix Derivative | Experimental | Biological: EmdogainⓇ(Enamel Matrix Derivative)Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative) |
| Enamel Matrix Derivative+Autogenous Bone | Experimental | Biological: EmdogainⓇEnamel Matrix Derivative+Autogenous BoneOpen Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)+Autogenous Bone |
Who may qualify
- Ages
- 32 to 57 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- no systemic diseases as diabetes mellitus or cardiovascular diseases that contraindicated periodontal surgery and could influence the outcome of the therapy; (b) no smoking (c) no medications affecting periodontal tissues; (d) no pregnancy or lactation; (e) a good level of oral hygiene (plaque index < 1, and full mouth bleeding on probing score <20% after initial periodontal treatment), (f) compliance with the maintenance programme and (g) presence of at least one intra-bony defect with a probing depth ≥6 mm, radiographic depth of the defect ≥3 mm as detected on the radiographs.
Key exclusion criteria (1 listed)
- pregnancy or lactating, (b) required an antibiotic premedication, (c) received antibiotic treatment in the previous 6 months, (d) smokers, (e) whose tooth had inadequate amount of attached keratinized gingiva (<1mm)
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 |
|---|---|---|
| Open Flap DebridementOpen Flap Debridement (Control Group) | Procedure or surgery | Open Flap Debridement |
| EmdogainⓇ(Enamel Matrix Derivative)Open Flap Debridement+Enamel Matrix Derivative | Biological | Enamel Matrix Derivative |
| EmdogainⓇEnamel Matrix Derivative+Autogenous BoneOpen Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)+Autogenous Bone | Biological | Enamel Matrix Derivative+Autogenous Bone |
Primary outcome
Attachment Gain
Time frame: 6 months after surgery
1 secondary outcome
Gingival crevicular fluid TGF-β1 level
Time frame: 1 week, 2 weeks, 4 weeks, 12 weeks and 72 weeks after surgery
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 18 Aug 2014.
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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.
Ömer Birkan Ağralı, Dr. principal investigator
Marmara University Faculty of Dentistry, Department of Periodontology
Bahar Kuru, Prof. Dr. study chair
Marmara University, Faculty of Dentistry, Department of Periodontology
Leyla Kuru, Prof. Dr. study director
Marmara 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 Phase 4 study testing Open Flap Debridement, EmdogainⓇ(Enamel Matrix Derivative) and EmdogainⓇEnamel Matrix Derivative+Autogenous Bone in people with Periodontal Bone Loss and Chronic Periodontitis, run by Haner Direskeneli, Prof 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 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 18 Aug 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Attachment Gain (time frame: 6 months after surgery). 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 18 Aug 2014.