A randomized clinical trial comparing enamel matrix derivative and membrane treatment of buccal class II furcation involvement in mandibular molars. Part II: secondary outcomes.

BACKGROUND: This multicenter, randomized trial compared enamel matrix derivative (EMD) with barrier membranes for the treatment of Class II mandibular furcations with regard to secondary outcomes. The influence of furcation morphology on the effectiveness of either treatment was also evaluated. METHODS: Forty-eight patients (age range 28 to 73 years; 22 females, 26 males) with buccal Class II furcation involvements in both contralateral lower first or second molars were included. After initial periodontal treatment, defects were randomized to either EMD or bioabsorbable guided tissue regeneration (GTR) barrier. Study design and the results for the primary parameter were previously described. Results of the following secondary outcome variables are reported here: changes of the hard tissue boundaries describing the anatomical situation of the furcation defect and changes in the following clinical parameters between baseline and 14 months: plaque, level of gingival margin, probing depth, bleeding on probing, attachment level, and bone sounding at five sites/tooth at the buccal side. Descriptive statistics were applied for changes in clinical parameters and measurements of hard tissue boundaries. The differences observed under treatment with EMD or membrane were analyzed by means of the Wilcoxon two-sample test. The difference between the effect of the EMD and membrane treatment was estimated by means of the Hodges-Lehmann estimator. RESULTS: Overall, similar healing results were observed for both treatments. However, there was slightly more recession in the mid-furcation site following membrane treatment (P = 0.04). Additionally, different treatment effects could be detected for the distances from the stent or cemento-enamel junction (CEJ) to the buccal bone crest, mid-distal root (Pstent = 0.01; PCEJ = 0.07) and for the distance from the stent or CEJ to the buccal bone crest, mid-mesial root (Pstent = 0.01; PCEJ = 0.01). There was no measurable bone resorption in EMD sites, whereas a slight resorption occurred with membrane treatment. Furcation morphology at the time of surgery was not associated with clinical outcome, irrespective of the treatment. CONCLUSION: With regard to secondary outcome parameters, enamel matrix derivative treatment led to a similar regenerative result as the membrane procedure.

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.

BACKGROUND: The objective of this multicenter, randomized trial was to compare enamel matrix derivative (EMD; test) with barrier membranes (control) for the treatment of mandibular buccal Class II furcation defects. METHODS: Forty-five patients with 90 comparable defects on contralateral molars were included. Defects were randomly assigned to EMD or bioabsorbable barrier membrane; the contralateral defect received the alternative treatment. Assessments at baseline and 8 and 14 months included gingival margin levels, probing depths, bleeding on probing, vertical attachment levels, and vertical bone sounding from a stent at five buccal sites/ tooth. Defect dimensions were recorded at surgery and during reentry at 14 months. Change of open horizontal furcation depth was the primary outcome variable. Adverse reactions and patient perceptions were also noted. RESULTS: Both treatment modalities led to significant clinical improvements. The median reduction of open horizontal furcation depth was 2.8 mm with the corresponding interquartile interval (1.5 mm, 3.5 mm) at test sites compared with 1.8 mm (1.0 mm, 2.8 mm) at control sites. The Hodges-Lehmann estimator of the advantage (reduction test versus control) was 0.75 mm (95% confidence interval [CI]: 0.125 mm, 1.375 mm, P = 0.033, Wilcoxon). The frequency of complete furcation closure was 8/45 (test) and 3/45 (control); partial closure, 27/45 in both groups; no change, 9/45 and 11/45, respectively; and deterioration, 1/45 and 4/45, respectively. The frequency of no pain or no swelling at 1 week post-surgery was 62% and 44%, respectively, at the test sites and 12% and 6% at the control sites. CONCLUSION: There was a significantly greater reduction in horizontal furcation depth and a comparatively lower incidence of postoperative pain/swelling following enamel matrix derivative compared to membrane therapy.

A randomized clinical multicentre trial comparing enamel matrix derivative and membrane treatment of buccal class II furcation involvement in mandibular molars. Part III: patient factors and treatment outcome.

OBJECTIVE: Evaluation of effects of patient factors on the outcome of regenerative treatment of buccal mandibular class II furcation defects. MATERIAL AND METHODS: Fifty-one patients were recruited. In the intention-to-treat population 21 patients were allocated into the sequence left treatment with enamel matrix protein derivative (EMD) and right guided tissue regeneration (GTR) and 27 in the sequence left GTR and right EMD. Evaluated patient factors were: smoking, age, gender, hypertension and oral hygiene status. Outcome parameters included change of: (a) horizontal depth of the defect at the deepest point (b) distance from the fornix of the furcation to bone crest of the defect, (c) distance from stent to the bottom of the defect, (d) pocket depth and (e) attachment level at the middle of the furcation. RESULTS: In patients 54 years of age and older, in males, in non-smokers and in patients with "poor" hygiene EMD-treated sites showed a significant higher mean reduction of the parameters d (age), b (gender, hygiene) a (smoking, hygiene) when compared with sites treated with GTR. CONCLUSIONS: These data provided an indication of a possible effect of patient factors on the outcome of regenerative treatment of buccal mandibular class II furcation defects.