Profile
International Journal of Clinical Research & Trials Volume 2 (2017), Article ID 2:IJCRT-116, 12 pages
https://doi.org/10.15344/2456-8007/2017/116
Study Protocol
Alveolar Ridge Preservation as a Way to Reduce the Need for Bone Augmentation: Implementation of a New, Non-invasive Method of Measuring Bone Preservation: Study Protocol of a Randomized Controlled Clinical Trial and Feasibility Testing Results

Sigmar Schnutenhaus1,3*, Jens Dreyhaupt2, Isabel Doering3, Heike Rudolph1 and Ralph G. Luthardt1

1Department of Prosthetic Dentistry, Center of Dentistry, University of Ulm, Germany
2Institute of Epidemiology and Medical Biometry, University of Ulm, Germany
3Private practice, Hilzingen, Germany
Dr. Sigmar Schnutenhaus, Department of Prosthetic Dentistry, Center of Dentistry, University of Ulm, Breiter Wasmen 10 D 78247 Hilzingen, Germany; E-mail: sigmar.schnutenhaus@uniklinik-ulm.de
25 May 2017; 08 July 2017; 10 July 2017
Schnutenhaus S, Doering I, Dreyhaupt J, Rudolph H, Luthardt RG (2017) Alveolar Ridge Preservation as a Way to Reduce the Need for Bone Augmentation: Implementation of a New, Non-invasive Method of Measuring Bone Preservation: Study Protocol of a Randomized Controlled Clinical Trial and Feasibility Testing Results. Int J Clin Res Trials 2: 116. doi: https://doi.org/10.15344/2456-8007/2017/116
Resorba Medical GmbH (Nürnberg, Germany) and the Camlog Foundation (Basel, Switzerland) (Grant No. CF 41305).
German Clinical Trial Register and the International Clinical Trials Registry Platform of the WHO: DRKS00004769 (pre-study) date of registration: 2013/02/28 and DRKS00005978 (main trial) date of registration: 2015/11/09.

Abstract

Introduction: The efficacy of alveolar ridge preservation (ARP) in preserving the bone after tooth extractions and before rehabilitation with an implant-supported restoration is examined. A new, non-invasive measurement method to determine the extent of bone preservation is presented. This measurement method is based on a 3D comparison of the condition immediately after extraction with the data of a cone-beam computed tomography (CBCT) eight weeks after extraction.
Method: The study is a single-center, randomized, controlled parallel-group clinical investigation. 88 patients who required extraction of a maxillary tooth participated in the study. In 44 patients (intervention group), the socket is filled with a combination of a collagen plug and a collagen membrane introduced in the empty socket immediately after tooth removal (ARP). The 44 patients (control group) experience unassisted socket healing the hyporeflective space. Primary endpoints are (1) bone loss after tooth extraction; (2) the preservation of the alveolar ridge (soft tissue and bone); (3) the need for augmentation during the subsequent implant treatment; and (4) the question whether ARP is more costeffective than the therapy with unassisted socket healing. Patients will be followed for 5 years.
Discussion: The extent of bone resorption after tooth extraction significantly influences the subsequent implant placement. Preserving the bone as well as possible is of great importance for the stability, prosthetically correct position and long-term functional success of the implantological treatment. A new, non-invasive method, without additional, study-related X-ray exposure, presented here for the first time, the change in volume of the bone bed can be analyzed. The preliminary results of this feasibility test report a median value of buccal and palatal bone loss of 6.2 mm (control)/4.4 mm (test) and 2.5 mm (control)/2.8 mm (test), respectively. These values are comparable to studies that also determined bone resorption by CBCT.