Clinical outcomes after treatment of intra-bony defects with an EMD/synthetic bone graft or EMD alone: a multicentre randomized-controlled clinical trial.

OBJECTIVES Comparison of the outcomes of a combination of an enamel matrix derivative and a synthetic bone graft (EMD/SBC) with EMD alone in wide intra-bony defects. MATERIAL AND METHODS Seventy-three patients with chronic periodontitis were recruited in five centres in Germany. All patients had one wide intra-bony defect of >/=4 mm. Surgical procedures involved microsurgical technique and the modified papilla preservation flap. After debridement, defects were randomly assigned to EMD/SBC (test) or EMD (control). Assessments at baseline and after 6 months included bone sounding, attachment levels, probing pocket depths, bleeding on probing and recessions. Early wound-healing, adverse effects and patients' perceptions were also recorded. RESULTS Both treatment modalities led to significant clinical improvements. Change in bone fill 6 months after surgery was 2.0 mm (+/- 2.1) in the test group and 2.1 mm (+/- 1.2) in the control group. A gain in clinical attachment of 1.3 mm (+/- 1.8) in the test group and 1.8 mm (+/- 1.6) in the control group was observed. One week after surgery, primary closure was maintained in 95% of the test sites and 100% of the control sites. No differences in patients' perceptions were found. CONCLUSION The results of the present study showed similar clinical outcomes following both treatment modalities.

[1]  B. Willershausen,et al.  Treatment of Intrabony Defects Using Guided Tissue Regeneration and Autogenous Spongiosa Alone or Combined With Hydroxyapatite/β-Tricalcium Phosphate Bone Substitute or Bovine-Derived Xenograft. , 2007, Journal of periodontology.

[2]  A. Sculean,et al.  Four-year results of a prospective-controlled clinical study evaluating healing of intra-bony defects following treatment with an enamel matrix protein derivative alone or combined with a bioactive glass. , 2007, Journal of clinical periodontology.

[3]  L. Trombelli,et al.  Effect of autogenous cortical bone particulate in conjunction with enamel matrix derivative in the treatment of periodontal intraosseous defects. , 2007, Journal of periodontology.

[4]  U. Schlagenhauf,et al.  Primary flap closure combined with Emdogain alone or Emdogain and Cerasorb in the treatment of intra-bony defects. , 2006, Journal of clinical periodontology.

[5]  A. Sculean,et al.  Clinical evaluation of an enamel matrix protein derivative combined with either a natural bone mineral or beta-tricalcium phosphate. , 2005, Journal of periodontology.

[6]  L. Trombelli.  Which reconstructive procedures are effective for treating the periodontal intraosseous defect? , 2005, Periodontology 2000.

[7]  N. Lang,et al.  Healing, post-operative morbidity and patient perception of outcomes following regenerative therapy of deep intrabony defects. , 2004, Journal of clinical periodontology.

[8]  B. Boyan,et al.  The use of enamel matrix derivative in the treatment of periodontal defects: a literature review and meta-analysis. , 2004, Critical reviews in oral biology and medicine : an official publication of the American Association of Oral Biologists.

[9]  M. Mills,et al.  Clinical evaluation of demineralized freeze-dried bone allograft and enamel matrix derivative versus enamel matrix derivative alone for the treatment of periodontal osseous defects in humans. , 2004, Journal of periodontology.

[10]  R. Bödeker,et al.  A randomized clinical trial comparing enamel matrix derivative and membrane treatment of buccal Class II furcation involvement in mandibular molars. Part I: Study design and results for primary outcomes. , 2004, Journal of periodontology.

[11]  J. Sjögren,et al.  The effect of vacuum‐assisted closure therapy on the pig femoral artery vasomotor responses , 2004, Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society.

[12]  G. Zucchelli,et al.  Enamel matrix proteins and bovine porous bone mineral in the treatment of intrabony defects: a comparative controlled clinical trial. , 2003, Journal of periodontology.

[13]  M. Somerman,et al.  Growth and amelogenin-like factors in periodontal wound healing. A systematic review. , 2003, Annals of periodontology.

[14]  Markus B Hürzeler,et al.  Microsurgical access flap and enamel matrix derivative for the treatment of periodontal intrabony defects: a controlled clinical study. , 2003, Journal of clinical periodontology.

[15]  J. Lindhe,et al.  Group C summary , 2002 .

[16]  A. Sculean,et al.  Presence of an enamel matrix protein derivative on human teeth following periodontal surgery , 2002, Clinical Oral Investigations.

[17]  N. Lang,et al.  Enamel matrix proteins in the regenerative therapy of deep intrabony defects. , 2002, Journal of clinical periodontology.

[18]  J. Wennström,et al.  Some effects of enamel matrix proteins on wound healing in the dento-gingival region. , 2002, Journal of clinical periodontology.

[19]  L. Wolff,et al.  Levels of tissue inhibitor of metalloproteinases-1 and matrix metalloproteinases-1 and -8 in gingival crevicular fluid following treatment with enamel matrix derivative (EMDOGAIN). , 2001, Journal of periodontal research.

[20]  S. Froum,et al.  A comparative study utilizing open flap debridement with and without enamel matrix derivative in the treatment of periodontal intrabony defects: a 12-month re-entry study. , 2001, Journal of periodontology.

[21]  Z. Aleksic,et al.  A comparison between enamel matrix proteins used alone or in combination with bovine porous bone mineral in the treatment of intrabony periodontal defects in humans. , 2000, Journal of periodontology.

[22]  G. Daculsi,et al.  Biphasic calcium phosphate/hydrosoluble polymer composites: a new concept for bone and dental substitution biomaterials. , 1999, Bone.

[23]  G. Heden,et al.  Enamel matrix derivative (EMDOGAIN) in the treatment of intrabony periodontal defects. , 1997, Journal of clinical periodontology.

[24]  A. Brodin,et al.  Formulation of enamel matrix derivative for surface coating. Kinetics and cell colonization. , 1997, Journal of clinical periodontology.

[25]  L. Hammarström,et al.  Periodontal regeneration in a buccal dehiscence model in monkeys after application of enamel matrix proteins. , 1997, Journal of clinical periodontology.

[26]  L. Heijl.  Periodontal regeneration with enamel matrix derivative in one human experimental defect. A case report. , 1997, Journal of clinical periodontology.

[27]  E. Machtei,et al.  Outcome variables for the study of periodontal regeneration. , 1997, Annals of periodontology.

[28]  A. Polson.  The research team, calibration, and quality assurance in clinical trials in periodontics. , 1997, Annals of periodontology.

[29]  S. Lindskog,et al.  Smear removal and collagen exposure after non-surgical root planing followed by etching with an EDTA gel preparation. , 1996, Journal of periodontology.

[30]  M. Tonetti,et al.  The modified papilla preservation technique. A new surgical approach for interproximal regenerative procedures. , 1995, Journal of periodontology.

[31]  S. Lindskog,et al.  Root surface texture and early cell and tissue colonization after different etching modalities. , 1995, European journal of oral sciences.

[32]  K. Lynch,et al.  Tissue response to biphasic calcium phosphate ceramic with different ratios of HA/beta TCP in periodontal osseous defects. , 1992, Journal of periodontology.

[33]  P J Hanes,et al.  The production of a root surface smear layer by instrumentation and its removal by citric acid. , 1984, Journal of periodontology.

[34]  A. Polson,et al.  Effect of root surface alterations on periodontal healing. II. Citric acid treatment of the denuded root. , 1982, Journal of clinical periodontology.

[35]  T. O'Leary,et al.  The plaque control record. , 1972, Journal of periodontology.