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.

NCT ID: NCT02102360

Last Updated: 2014-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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

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Furcation Defects Periodontal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Minimally invasive surgical technique (MIST)

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.

Group Type EXPERIMENTAL

Anorganic Bovine Bone

Intervention Type DEVICE

used to improve periodontal regenerative procedures.

Enamel Matrix Derivative

Intervention Type DEVICE

used to improve periodontal regenerative procedures.

Conventional surgical technique (CST)

A conventional surgical technique was performed to access mandibular furcation defects in the control group.

Group Type EXPERIMENTAL

Anorganic Bovine Bone

Intervention Type DEVICE

used to improve periodontal regenerative procedures.

Enamel Matrix Derivative

Intervention Type DEVICE

used to improve periodontal regenerative procedures.

Interventions

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Anorganic Bovine Bone

used to improve periodontal regenerative procedures.

Intervention Type DEVICE

Enamel Matrix Derivative

used to improve periodontal regenerative procedures.

Intervention Type DEVICE

Other Intervention Names

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Anorganic Bovine Bone (Bio-Oss, Geistlich Pharma). Enamel Matrix Derivative (Emdogain - Institute Straumann, Switzerland).

Eligibility Criteria

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Inclusion Criteria

(I) 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%.

Exclusion Criteria

(I) 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Tulio Bonna Pignaton

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.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Oral & Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirao Preto, University of Sao Paulo

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 11338311 (View on PubMed)

Cortellini 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.

Reference Type BACKGROUND
PMID: 17243998 (View on PubMed)

Cortellini 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.

Reference Type BACKGROUND
PMID: 17953696 (View on PubMed)

Cortellini 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.

Reference Type BACKGROUND
PMID: 11276509 (View on PubMed)

Cortellini 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.

Reference Type BACKGROUND
PMID: 7782979 (View on PubMed)

Wang 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.

Reference Type BACKGROUND
PMID: 16171453 (View on PubMed)

Tsao 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.

Reference Type BACKGROUND
PMID: 16584345 (View on PubMed)

Martin 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.

Reference Type BACKGROUND
PMID: 3290276 (View on PubMed)

Hammarstrom 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.

Reference Type BACKGROUND
PMID: 9310871 (View on PubMed)

Hammarstrom 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.

Reference Type BACKGROUND
PMID: 9310870 (View on PubMed)

Heijl 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.

Reference Type BACKGROUND
PMID: 9310874 (View on PubMed)

Dori 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.

Reference Type BACKGROUND
PMID: 22873657 (View on PubMed)

Tonetti 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.

Reference Type BACKGROUND
PMID: 15560811 (View on PubMed)

Polimeni 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.

Reference Type BACKGROUND
PMID: 16686925 (View on PubMed)

Other Identifiers

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Mist2014

Identifier Type: -

Identifier Source: org_study_id

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