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.

NCT02102360 | Completed Phase 4

• 1 other identifier: Mist2014
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Furcation Defects; Periodontal Disease

Keywords

microsurgery, furcation defects, periodontal disease, enamel matrix proteins, bone substitutes

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and 6 months after surgical procedure

Secondary Outcomes (9)

• Pain Scores on the Visual Analogue Scale

  7 days after surgery

• Discomfort Scores on the Visual Analogue Scale

  7 days after surgery

• Edema Scores on the Visual Analogue Scale

  7 days after surgery

• Hematoma Scores on the Visual Analogue Scale

  7 days after surgery

• Root Hypersensitivity Scores on the Visual Analogue Scale

  7 days after surgery

Other Outcomes (1)

• Digital subtraction radiography density gain

  baseline and 6 months

Study Arms (2)

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.

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.

Device: Anorganic Bovine Bone; Device: Enamel Matrix Derivative

Interventions

Anorganic Bovine Bone DEVICE

used to improve periodontal regenerative procedures.

Also known as: Anorganic Bovine Bone (Bio-Oss, Geistlich Pharma).

Conventional surgical technique (CST); Minimally invasive surgical technique (MIST)

Enamel Matrix Derivative DEVICE

used to improve periodontal regenerative procedures.

Also known as: Enamel Matrix Derivative (Emdogain - Institute Straumann, Switzerland).

Conventional surgical technique (CST); Minimally invasive surgical technique (MIST)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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%.

You may not qualify if:

• (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)

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

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

Ribeirão Preto, São Paulo, 14040-904, Brazil

Location

Related Publications (14)

• 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.

  PMID: 11338311 BACKGROUND

• 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.

  PMID: 17243998 BACKGROUND

• 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.

  PMID: 17953696 BACKGROUND

• 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.

  PMID: 11276509 BACKGROUND

• 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.

  PMID: 7782979 BACKGROUND

• 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.

  PMID: 16171453 BACKGROUND

• 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.

  PMID: 16584345 BACKGROUND

• 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.

  PMID: 3290276 BACKGROUND

• 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.

  PMID: 9310871 BACKGROUND

• 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.

  PMID: 9310870 BACKGROUND

• 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.

  PMID: 9310874 BACKGROUND

• 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.

  PMID: 22873657 BACKGROUND

• 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.

  PMID: 15560811 BACKGROUND

• 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.

  PMID: 16686925 BACKGROUND

MeSH Terms

Conditions

Furcation Defects; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI 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.

Study Record Dates

• First Submitted: March 26, 2014
• First Posted: April 2, 2014
• Study Start: March 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 2, 2014

Record last verified: 2014-03

Locations

BR (1)