Furcation DefectsPhase 4NCT02102360
Conventional or Minimally Invasive Surgical Technique for the Treatment of Furcation Defects Using Enamel Matrix Derivative and Anorganic Bovine Bone - a Randomized Controlled Clinical Trial.
A Phase 4 study testing Anorganic Bovine Bone and Enamel Matrix Derivative in people with Furcation Defects and Periodontal Disease, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This clinical study compared a conventional surgical technique (CST) and a minimally invasive surgical technique (MIST) in the regenerative treatment of mandibular furcation defects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Furcation Defects, Periodontal Disease
- What is being tested?
- Anorganic Bovine Bone and Enamel Matrix Derivative
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to Dec 2013
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subjects with a diagnosis of periodontitis; (II) presence of one pair of contralateral mandibular molars with buccal / lingual furcation defects; (III) non-smokers; (IV) plaque index < 20%.
Who cannot join
- patients that presented systemic disease; (II) had taken antibiotics in the past 6 months prior to surgery; (III) pregnant women or lactating mothers; (IV) molars with periapical disease; (V) cervical restorations or prosthesis closer than 1 mm to fornix; (VI) lingual furcation defects presenting gingival recession (GR)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Oral & Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirao Preto, University of Sao Paulo
Ribeirão Preto, São Paulo, 14040-904
About this study
This clinical study compared a conventional surgical technique (CST) and a minimally invasive surgical technique (MIST) in the regenerative treatment of mandibular furcation defects.
Read the detailed description
Using a split-mouth design, fifteen patients with bilateral class II and III furcation defects were treated with MIST (Test Group) or CST (Control Group). Furcation defects in both groups were filled with anorganic bovine bone (ABB) and enamel matrix derivative (EMD). Patient-centered outcomes including analyses of pain, discomfort, edema, hematoma, root hypersensitivity and daily activities interference were recorded using a Visual Analogue Scale seven days after surgeries. Clinical and radiographic parameters were assessed at baseline and 6 months postoperatively. Data were statistically analysed.
- Conditions
- Furcation Defects, Periodontal Disease
- Being tested
- Anorganic Bovine Bone, Enamel Matrix Derivative
- Keywords
- microsurgery, furcation defects, periodontal disease, enamel matrix proteins, bone substitutes
- Medical subject headings
- Furcation Defects, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anorganic Bovine BoneDevice
Also called Anorganic Bovine Bone (Bio-Oss, Geistlich Pharma).
used to improve periodontal regenerative procedures.
Enamel Matrix DerivativeDevice
Also called Enamel Matrix Derivative (Emdogain - Institute Straumann, Switzerland).
used to improve periodontal regenerative procedures.
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive surgical technique (MIST) | Experimental | A minimally invasive surgical technique was performed to access mandibular furcation defects in the test group, aiming to perform minimal flap reflection, minimal wound, and gentle handling of the soft and hard tissue in periodontal surgery. The use of a microsurgical approach provides magnification and optimal illumination of the surgical site improving visual acuity. Further advantages may be the reduction of flap reflection during surgery, consequently advantages in wound healing process and benefits in patient's perceptions of the procedure. A less invasive surgical procedure may lead to a less cell demand in the healing process, and a potentially reduced morbidity. The minimally invasive surgical procedures were performed using microscope. Receives: Device: Anorganic Bovine Bone; Device: Enamel Matrix Derivative |
| Conventional surgical technique (CST) | Experimental | A conventional surgical technique was performed to access mandibular furcation defects in the control group. Receives: Device: Anorganic Bovine Bone; Device: Enamel Matrix Derivative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal clinical attachment level (HCAL)
The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures.
Measured: baseline and 6 months after surgical procedure
Secondary outcomes (9)
Pain Scores on the Visual Analogue Scale
Measured: 7 days after surgery
Discomfort Scores on the Visual Analogue Scale
Measured: 7 days after surgery
Edema Scores on the Visual Analogue Scale
Measured: 7 days after surgery
Hematoma Scores on the Visual Analogue Scale
Measured: 7 days after surgery
Root Hypersensitivity Scores on the Visual Analogue Scale
Measured: 7 days after surgery
Daily Activities Interference Scores on the Visual Analogue Scale
Measured: 7 days after surgery
Vertical clinical attachment level (VCAL)
The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures.
Measured: baseline and 6 months
Probing pocket depth (PPD)
The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures
Measured: baseline and 6 months
Gingival recession
The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures
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 posted2 Apr 2014 (estimated)
- Study startMar 2012
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Furcation DefectsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tulio Bonna Pignaton, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102360
- Sponsor's protocol ID
- Mist2014
- Status last verified
- Mar 2014
- First submitted
- 26 Mar 2014
- Last updated
- 2 Apr 2014
- Results posted
- No
Publications
Cortellini P, Tonetti MS. Microsurgical approach to periodontal regeneration. Initial evaluation in a case cohort. J Periodontol. 2001 Apr;72(4):559-69. doi: 10.1902/jop.2001.72.4.559.
PubMed 11338311Cortellini P, Tonetti MS. A minimally invasive surgical technique with an enamel matrix derivative in the regenerative treatment of intra-bony defects: a novel approach to limit morbidity. J Clin Periodontol. 2007 Jan;34(1):87-93. doi: 10.1111/j.1600-051X.2006.01020.x.
PubMed 17243998Cortellini P, Tonetti MS. Minimally invasive surgical technique and enamel matrix derivative in intra-bony defects. I: Clinical outcomes and morbidity. J Clin Periodontol. 2007 Dec;34(12):1082-8. doi: 10.1111/j.1600-051X.2007.01144.x. Epub 2007 Oct 22.
PubMed 17953696Cortellini P, Tonetti MS. Focus on intrabony defects: guided tissue regeneration. Periodontol 2000. 2000 Feb;22:104-32. doi: 10.1034/j.1600-0757.2000.2220108.x. No abstract available.
PubMed 11276509Cortellini P, Prato GP, Tonetti MS. The modified papilla preservation technique. A new surgical approach for interproximal regenerative procedures. J Periodontol. 1995 Apr;66(4):261-6. doi: 10.1902/jop.1995.66.4.261.
PubMed 7782979Wang HL, Greenwell H, Fiorellini J, Giannobile W, Offenbacher S, Salkin L, Townsend C, Sheridan P, Genco RJ; Research, Science and Therapy Committee. Periodontal regeneration. J Periodontol. 2005 Sep;76(9):1601-22. doi: 10.1902/jop.2005.76.9.1601.
PubMed 16171453Tsao YP, Neiva R, Al-Shammari K, Oh TJ, Wang HL. Factors influencing treatment outcomes in mandibular Class II furcation defects. J Periodontol. 2006 Apr;77(4):641-6. doi: 10.1902/jop.2006.050133.
PubMed 16584345Martin M, Gantes B, Garrett S, Egelberg J. Treatment of periodontal furcation defects. (I). Review of the literature and description of a regenerative surgical technique. J Clin Periodontol. 1988 Apr;15(4):227-31. doi: 10.1111/j.1600-051x.1988.tb01575.x.
PubMed 3290276Hammarstrom L, Heijl L, Gestrelius S. Periodontal regeneration in a buccal dehiscence model in monkeys after application of enamel matrix proteins. J Clin Periodontol. 1997 Sep;24(9 Pt 2):669-77. doi: 10.1111/j.1600-051x.1997.tb00248.x.
PubMed 9310871Hammarstrom L. Enamel matrix, cementum development and regeneration. J Clin Periodontol. 1997 Sep;24(9 Pt 2):658-68. doi: 10.1111/j.1600-051x.1997.tb00247.x.
PubMed 9310870Heijl L. Periodontal regeneration with enamel matrix derivative in one human experimental defect. A case report. J Clin Periodontol. 1997 Sep;24(9 Pt 2):693-6. doi: 10.1034/j.1600-051x.1997.00693.x.
PubMed 9310874Dori F, Arweiler NB, Szanto E, Agics A, Gera I, Sculean A. Ten-year results following treatment of intrabony defects with an enamel matrix protein derivative combined with either a natural bone mineral or a beta-tricalcium phosphate. J Periodontol. 2013 Jun;84(6):749-57. doi: 10.1902/jop.2012.120238. Epub 2012 Aug 8.
PubMed 22873657Tonetti MS, Fourmousis I, Suvan J, Cortellini P, Bragger U, Lang NP; European Research Group on Periodontology (ERGOPERIO). Healing, post-operative morbidity and patient perception of outcomes following regenerative therapy of deep intrabony defects. J Clin Periodontol. 2004 Dec;31(12):1092-8. doi: 10.1111/j.1600-051X.2004.00615.x.
PubMed 15560811Polimeni G, Xiropaidis AV, Wikesjo UM. Biology and principles of periodontal wound healing/regeneration. Periodontol 2000. 2006;41:30-47. doi: 10.1111/j.1600-0757.2006.00157.x. No abstract available.
PubMed 16686925
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional or Minimally Invasive Surgical Technique for the Treatment of Furcation Defects Using Enamel Matrix Derivative and Anorganic Bovine Bone - a Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT02102360
- Acronym / sponsor ID
- Mist2014
- Conditions
- Furcation Defects, Periodontal Disease
- Keywords
- microsurgery, furcation defects, periodontal disease, enamel matrix proteins, bone substitutes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 2 Apr 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.
This clinical study compared a conventional surgical technique (CST) and a minimally invasive surgical technique (MIST) in the regenerative treatment of mandibular furcation defects.
Detailed description
Using a split-mouth design, fifteen patients with bilateral class II and III furcation defects were treated with MIST (Test Group) or CST (Control Group). Furcation defects in both groups were filled with anorganic bovine bone (ABB) and enamel matrix derivative (EMD). Patient-centered outcomes including analyses of pain, discomfort, edema, hematoma, root hypersensitivity and daily activities interference were recorded using a Visual Analogue Scale seven days after surgeries. Clinical and radiographic parameters were assessed at baseline and 6 months postoperatively. Data were statistically analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive surgical technique (MIST) | Experimental | Device: Anorganic Bovine Bone, Device: Enamel Matrix DerivativeA minimally invasive surgical technique was performed to access mandibular furcation defects in the test group, aiming to perform minimal flap reflection, minimal wound, and gentle handling of the soft and hard tissue in periodontal surgery. The use of a microsurgical approach provides magnification and optimal illumination of the surgical site improving visual acuity. Further advantages may be the reduction of flap reflection during surgery, consequently advantages in wound healing process and benefits in patient's perceptions of the procedure. A less invasive surgical procedure may lead to a less cell demand in the healing process, and a potentially reduced morbidity. The minimally invasive surgical procedures were performed using microscope. |
| Conventional surgical technique (CST) | Experimental | Device: Anorganic Bovine Bone, Device: Enamel Matrix DerivativeA conventional surgical technique was performed to access mandibular furcation defects in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subjects with a diagnosis of periodontitis; (II) presence of one pair of contralateral mandibular molars with buccal / lingual furcation defects; (III) non-smokers; (IV) plaque index < 20%.
Key exclusion criteria (1 listed)
- patients that presented systemic disease; (II) had taken antibiotics in the past 6 months prior to surgery; (III) pregnant women or lactating mothers; (IV) molars with periapical disease; (V) cervical restorations or prosthesis closer than 1 mm to fornix; (VI) lingual furcation defects presenting gingival recession (GR)
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 BoneAlso: Anorganic Bovine Bone (Bio-Oss, Geistlich Pharma).used to improve periodontal regenerative procedures. | Device | Conventional surgical technique (CST), Minimally invasive surgical technique (MIST) |
| Enamel Matrix DerivativeAlso: Enamel Matrix Derivative (Emdogain - Institute Straumann, Switzerland).used to improve periodontal regenerative procedures. | Device | Conventional surgical technique (CST), Minimally invasive surgical technique (MIST) |
Primary outcome
Horizontal clinical attachment level (HCAL)
Time frame: baseline and 6 months after surgical procedure
The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures.
9 secondary outcomes
Pain Scores on the Visual Analogue Scale
Time frame: 7 days after surgery
Discomfort Scores on the Visual Analogue Scale
Time frame: 7 days after surgery
Edema Scores on the Visual Analogue Scale
Time frame: 7 days after surgery
Hematoma Scores on the Visual Analogue Scale
Time frame: 7 days after surgery
Root Hypersensitivity Scores on the Visual Analogue Scale
Time frame: 7 days after surgery
Daily Activities Interference Scores on the Visual Analogue Scale
Time frame: 7 days after surgery
Vertical clinical attachment level (VCAL)
Time frame: baseline and 6 months
Probing pocket depth (PPD)
Time frame: baseline and 6 months
Gingival recession
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 2 Apr 2014.
- Background: PubMed 11338311Cortellini P, Tonetti MS. Microsurgical approach to periodontal regeneration. Initial evaluation in a case cohort. J Periodontol. 2001 Apr;72(4):559-69. doi: 10.1902/jop.2001.72.4.559.
- Background: PubMed 17243998Cortellini P, Tonetti MS. A minimally invasive surgical technique with an enamel matrix derivative in the regenerative treatment of intra-bony defects: a novel approach to limit morbidity. J Clin Periodontol. 2007 Jan;34(1):87-93. doi: 10.1111/j.1600-051X.2006.01020.x.
- Background: PubMed 17953696Cortellini P, Tonetti MS. Minimally invasive surgical technique and enamel matrix derivative in intra-bony defects. I: Clinical outcomes and morbidity. J Clin Periodontol. 2007 Dec;34(12):1082-8. doi: 10.1111/j.1600-051X.2007.01144.x. Epub 2007 Oct 22.
- Background: PubMed 11276509Cortellini P, Tonetti MS. Focus on intrabony defects: guided tissue regeneration. Periodontol 2000. 2000 Feb;22:104-32. doi: 10.1034/j.1600-0757.2000.2220108.x. No abstract available.
- Background: PubMed 7782979Cortellini P, Prato GP, Tonetti MS. The modified papilla preservation technique. A new surgical approach for interproximal regenerative procedures. J Periodontol. 1995 Apr;66(4):261-6. doi: 10.1902/jop.1995.66.4.261.
- Background: PubMed 16171453Wang HL, Greenwell H, Fiorellini J, Giannobile W, Offenbacher S, Salkin L, Townsend C, Sheridan P, Genco RJ; Research, Science and Therapy Committee. Periodontal regeneration. J Periodontol. 2005 Sep;76(9):1601-22. doi: 10.1902/jop.2005.76.9.1601.
- Background: PubMed 16584345Tsao YP, Neiva R, Al-Shammari K, Oh TJ, Wang HL. Factors influencing treatment outcomes in mandibular Class II furcation defects. J Periodontol. 2006 Apr;77(4):641-6. doi: 10.1902/jop.2006.050133.
- Background: PubMed 3290276Martin M, Gantes B, Garrett S, Egelberg J. Treatment of periodontal furcation defects. (I). Review of the literature and description of a regenerative surgical technique. J Clin Periodontol. 1988 Apr;15(4):227-31. doi: 10.1111/j.1600-051x.1988.tb01575.x.
- Background: PubMed 9310871Hammarstrom L, Heijl L, Gestrelius S. Periodontal regeneration in a buccal dehiscence model in monkeys after application of enamel matrix proteins. J Clin Periodontol. 1997 Sep;24(9 Pt 2):669-77. doi: 10.1111/j.1600-051x.1997.tb00248.x.
- Background: PubMed 9310870Hammarstrom L. Enamel matrix, cementum development and regeneration. J Clin Periodontol. 1997 Sep;24(9 Pt 2):658-68. doi: 10.1111/j.1600-051x.1997.tb00247.x.
- Background: PubMed 9310874Heijl L. Periodontal regeneration with enamel matrix derivative in one human experimental defect. A case report. J Clin Periodontol. 1997 Sep;24(9 Pt 2):693-6. doi: 10.1034/j.1600-051x.1997.00693.x.
- Background: PubMed 22873657Dori F, Arweiler NB, Szanto E, Agics A, Gera I, Sculean A. Ten-year results following treatment of intrabony defects with an enamel matrix protein derivative combined with either a natural bone mineral or a beta-tricalcium phosphate. J Periodontol. 2013 Jun;84(6):749-57. doi: 10.1902/jop.2012.120238. Epub 2012 Aug 8.
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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.
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 Anorganic Bovine Bone and Enamel Matrix Derivative in people with Furcation Defects and Periodontal Disease, run by University of Sao Paulo at 1 site in Brazil.
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 2 Apr 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 Brazil. 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?
Horizontal clinical attachment level (HCAL) (time frame: baseline and 6 months after surgical procedure). 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 NCT02102360, which also lists 14 linked publications.
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 2 Apr 2014.