Healing of intrabony defects following surgical treatment with or without an Er:YAG Laser. A multicenter, randomized, controlled clinical study
A. Sculean1*, F. Schwarz2, M. Berakdar1, C. Nicolaescu1, E. Reich3, J. Becker2
1Department of Conservative Dentistry, Johannes Gutenberg-University Mainz; 2Department of Oral Surgery, Heinrich Heine University Düsseldorf; 3KaVo, Biberach, Germany
One of the main goals in periodontal therapy is to arrest disease progression and further attachment loss. In most of the cases this goal can be achieved by means of nonsurgical periodontal therapy including root surface instrumentation with hand or sonic and ultrasonic devices. Recent results from controlled clinical trials and case report studies have also provided evidence that non-surgical periodontal treatment with an Er:YAG laser may also lead to significant gains of clinical attachment level which are comparable to those obtained after treatment with hand or ultrasonic instruments. However, if the pocket depth exceeds a certain limit, nonsurgical therapy may not completely remove the soft and hard bacterial deposits from the root surfaces.
Very recent histological and clincal results have indicated that treatment of deep intrabony defects with access flap surgery and debridement with an Er:YAG laser may result in a more favorable healing than treatment with flap surgery alone. However, it has to be pointed out that the results, although very positive, were obtained in a pilot study with a limited number of patients (i.e. 23). Thus, in order to have the final evidence on the statistical and clinical superiority of the flap surgery with laser, a higher number of patients and defects are needed. Furhermore, in order to meet the highest criteria of clinical evidence, the study needs to be performed as a multicenter, randomized, blinded, controlled clinical trial (RCT).
Therefore, the aim of this randomized, blinded, controlled clinical trial (RCT) will be to compare the healing of intrabony periodontal defects following treatment with access flap surgery with and without debridement with an Er:YAG Laser.
60 patients with one deep intrabony defect will be randomly treated with either access flap surgery and defect debridement with an Er:YAG Laser (KEY3® KaVo, Biberach, Germany) (160 mJ, 10 Hz) (test), or with access flap surgey alone followed by scaling and root planing with hand and- ultrasonic instruments (control). The following clinical parameters will be recorded at baseline and at 1 year: plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), gingival recession (GR), clinical attachment level (CAL) and x-rays.