J Clin Periodontol 2007; 34: 72–77 doi: 10.1111/j.1600-051X.2006.01007.x Five-year results of a prospective, Anton Sculean1, Frank Schwarz2, Giovanni C. Chiantella1,Nikolaos Donos3, Nicole B. Arweiler4, Michel Brecx1 and Ju¨rgen Becker21Department of Periodontology, RadboudUniversity Medical Center, Nijmegen, The evaluating treatment of intra-bony Netherlands; 2DepartmentofOralSurgery, Heinrich-Heine University, Du¨sseldorf,Germany; 3Department of Periodontology, Eastman Dental Institute, London, UK;4Department of Operative Dentistry andPeriodontology, Albert-Ludwigs University,Freiburg, Germany Sculean A, Schwarz F, Chiantella GC, Donos N, Arweiler NB, Brecx M, Becker J.
Five-year results of a prospective, randomized, controlled study evaluating treatmentof intra-bony defects with a natural bone mineral and GTR. J Clin Periodontol 2007;34: 72–77. doi: 10.1111/j.1600-051X.2006.01007.x.
AbstractBackground: Treatment with a natural bone mineral (NBM) and a guided tissueregeneration (GTR) has been shown to promote periodontal regeneration. However,until now there are only very limited data on the long-term clinical results followingthis regenerative technique.
Aim: To present the 5-year results of a prospective, randomized, controlled clinicalstudy evaluating the treatment of deep intra-bony defects either with open flapdebridement (OFD) and a combination of an NBM and GTR (test) or OFD alone(control).
Methods: Nineteen patients diagnosed with advanced chronic periodontitis, and eachof whom displayed one intra-bony defect, received randomly the test or the controltreatment. Results were evaluated at baseline, at 1 and at 5 years following therapy.
Results: No statistically significant differences in any of the investigated parameterswere observed at baseline between the two groups. At 1 year after therapy, the testgroup showed a reduction in mean probing depth (PD) from 9.1 Æ 1.1 to 3.7 Æ 0.8 mm( po0.001) and a change in mean clinical attachment level (CAL) from 10.4 Æ 1.3 to6.4 Æ 1.2 mm ( po0.001). At 5 years, mean PD and CAL measured 4.3 Æ 0.8 and6.7 Æ 1.6 mm, respectively. At 5 years, both PD and CAL were statisticallysignificantly improved compared with baseline ( po0.001) without statisticallysignificant differences between the 1- and 5-year results. In the control group, mean PDwas reduced from 8.9 Æ 1.3 to 4.9 Æ 1.2 mm ( po0.001) and mean CAL changed from10.6 Æ 1.4 to 8.8 Æ 1.5 mm ( po0.01). At 5 years, mean PD and CAL measured5.6 Æ 1.1 and 9.1 Æ 1.3 mm, respectively, and were still statistically significantlyimproved compared with baseline ( po0.01). No statistically significant differenceswere found between the 1- and 5-year results. The test treatment, at both 1 and 5 years,yielded statistically significantly higher CAL gains than the control one ( po0.01).
Compared with baseline, at 5 years a CAL gain of X3 mm was found in nine defects(90%) of the test group but in none of the defects treated with OFD alone.
Conclusions: It was concluded that (i) treatment of intra-bony defects with clinical study; guided tissue regeneration; long-term results; natural bone mineral; open flap OFD1NBM1GTR may result in significantly higher CAL gains than treatment with debridement; regenerative periodontal therapy OFD, and (ii) the clinical results obtained after both treatments can be maintained overa period of 5 years.
Accepted for publication 8 September 2006 r 2006 The Authors. Journal compilation r 2006 Blackwell Munksgaard Treatment of intra-bony defects with a natural bone mineral and GTR the restitution of the tooth’s supporting periodontal tissues (i.e. new periodontal not visible, a restoration margin was used periodontal disease (Karring et al. 2003).
regeneration implies the fill of the intra- selected defects. Pre- and post-operative reasons: five patients refused to partici- Lundgren & Slotte 1999, Camargo et al.
effects of the prognostic variables INTRA Lin˜ares et al. 2006). Histological studies study, all patients received oral hygiene osteoconductive properties and integrates performing transgingival bone sounding.
with ultrasonic and hand instruments.
months following initial therapy, re-eva- al. 2001, Paolantonio 2002, Sculean et al.
Five patients, each showing 10 teeth (sin- ated and, until now, no adverse reactions whether the patient fulfilled the following such as allergies or rejection of the graft were used to calibrate the examiner.
particles related to the material have been two separate occasions, 48 h apart. Cali- et al. 1999, Camargo et al. 2000, Mellonig 2000, Zitzmann et al. 2001, Sculean et al.
Lo¨e 1967], (3) compliance with the main- 2003a, b, 2004a, 2005, Tonetti et al. 2004, Lin˜ares et al. 2006). Findings from con- was not aware of the surgical procedure to trolled clinical studies have indicated that treatment of intra-bony defects with open other teeth than at those involved in the study, appropriate treatment was rendered 2000, Paolantonio 2002, Sculean et al.
2003a, 2005, Tonetti et al. 2004, Lin˜ares et al. 2006). Although the available data were raised vestibularly and orally. Ver- very limited data from controlled clinical only if necessary for a better access, or following treatment of intra-bony defects to achieve a better closure of the surgi- using hand and ultrasonic instruments.
results (1-year data) have been described in detail previously (Sculean et al.
r 2006 The Authors. Journal compilation r 2006 Blackwell Munksgaard Table 1. Plaque index (PI), gingival index (GI) and bleeding on probing (BOP) at baseline at 1 and at 5 years following treatment with test or control filled with bovine porous bone mineralgranules of particle size 0.25–1.0 mm overfill the defects. Following grafting, entire defect, so as to cover 2–3 mm of ensure stability of the graft material.
brane fixation or stabilization. Finally, tioned coronally and fixed with verticalor horizontal mattress sutures.
No significant differences between the test and control group were found.
used for the control sites, without theuse of NBM or GTR.
Table 2. Distribution and configuration of (2 Â 600 mg ibuprofen/day for 3 days).
within the first days after surgery.
any of the baseline defect characteristics first 2 months after surgery, and monthly patients reported a high degree of satis- formed during the first year after surgery.
patients were recalled every 3 months.
sures and professional supragingival tooth found to be statistically significant com- results. A statistically significant differ- and 5-year results. In the control group, to 1 year, the paired t-test was used. For r 2006 The Authors. Journal compilation r 2006 Blackwell Munksgaard Treatment of intra-bony defects with a natural bone mineral and GTR Table 3. Baseline defect characteristics expressed in millimetre (mean Æ SD) Table 7. Frequency distribution of clinicalattachment level (CAL) gain after 5 years in PD, probing depth; GR, gingival recession; CAL, clinical attachment level; CEJ–BD, cemento-enamel junction to the bottom of the defect; CEJ–BC, distance from the CEJ to the most coronal extension of the alveolar bone crest.
Table 4. Clinical parameters at baseline and 1 year for the test and control groups defects with both the combination ofOFD1NBM1GTR and OFD alone maylead to clinically and statistically signifi- Table 5. Clinical parameters at baseline and 5 years for the test and control groups clinical results measured at 1 year weremaintained in both groups over a period years, has led to statistically significantly in the control group, respectively. These 1-year results are in agreement with pre- ments using a comparable study design(Camargo et al. 2000, Tonetti et al. 2004).
Table 6. Clinical parameters at 1 and 5 years for the test and control groups In the mentioned studies, treatment withOFD1NBM1GTR resulted in a mean reported results (Cortellini et al. 1996, 2004b, Tonetti et al. 2004). Slight differ- ences in the results may be explainedwith baseline defect depth and configura-tion and/or differences in the surgical 1- and 5-year results. The test treatment, defects lost 2 and 1 mm, respectively, of surgery is strongly influenced by initial r 2006 The Authors. Journal compilation r 2006 Blackwell Munksgaard gain; Cortellini et al. 1998, Tonetti et al.
dontal disease (Tonetti et al. 1996).
2004, Tsitoura et al. 2004, Lin˜ares et al.
data, thus indicating long-term stability 19 out of the originally 28 patients were completely maintain the soft tissues sur- maintained over a period of 5 years.
(Tonetti et al. 2002, 2004, Cortellini & fonded by the authors’ own institution.
ranted to confirm the present findings.
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(2001) Periodontal regeneration with an anto- genous bone-Bio-Oss composite graft and a Bio-Gide membrane. The International Jour- nal of Periodontics and Restoritave Dentistry Camelo, M., Nevins, M. L., Schenk, R., Simion, M., Rasperini, G., Lynch, S. & Nevins, M.
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