Assessment of histological, clinical and radiographic outcomeُs of maxillary sinus augmentation using two different xenograft materials: split mouth clinical trial

Evaluation and comparison of two xenografts in maxillary sinus augmentation

Controlled randomized clinical trial, double blind, parallel group design of 12 patients. Coin toss will be used for randomization.

The present study will be performed at the periodontics department, Shahid Beheshti Dental School for patients who need an implant in the posterior maxilla. Tomographic radiographs are obtained and if the distance between the alveolar ridge and the floor of the maxillary sinus is less than 5 mm, they will enter the study after obtaining an informed consent. Randomization is done by tossing coins on the day of surgery. Patients are unaware of the type of grafting material used on each side of the mouth. Blinding will be performed for individuals performing clinical, radiographic, and histological evaluation.

Inclusion criteria: > 18 years, good general health, inadequate bone for a standard implant (< 5 mm residual alveolar bone height to the maxillary sinus floor), absence of infection or periapical lesion Exclusion criteria: smoking, O'Leary plaque index > 20%, allergy to the material used in the study, pregnancy/ lactation, uncontrolled periodontal disease, systemic disease or intake of any medication, history of sinusitis or any pathologic condition in the sinus

The "intervention group" consists of the use of Bone+ (Novateb Pars, Iran) on one side and the "control group" includes the use of OCS-B (Nibec Co., Korea) on the other side of the mouth of each participant for lateral window maxillary sinus augmentation.

Sinus augmentation volume; New bone formation; Residual material; Inflammation rate; Type of inflammation; Granulation tissue; Necrotic tissue; Giant cell

The study is performed as a split mouth investigation. The left or right side of each participant would be randomized into either the test group or the control group. Simple randomization will be used to select the type of material at each side. After elevation the sinus membrane, the coin toss method will be used to select the type of material in the right maxillary sinus. Bone+ would be used if the coin lands with heads side up, and OCS-B would be used if the coin lands with tails side up. The left sinus would be augmented with the other material. Only the surgeon and the person performing the randomization are aware of the sample allocation. Patients and individuals performing clinical and histological evaluations would be masked to the grouping information.

The principal investigator who performs randomization during surgery and the surgeon are aware of the type of material used. Participants are informed about the process of study and using two types of bone grafting materials; however, they are masked to the grouping information. The surgery would be first performed on the right sinus in each participant. After preparation of the sinus cavity, the principal investigator would randomly determine the type of substance to be used in the right sinus; the material will be given to the surgeon in such a way that the participant is prevented to get aware of the name of the material. A unique code would be assigned for each patient and sinus by the principal investigator, and all subsequent evaluations will be based on the codes. Postoperative clinical evaluation will be performed by a person who is unaware of the type of material used. Recording of pre- and post-operative radiographic information is done by an oral radiologist who has no knowledge of the type of material used based on the provided codes. The histologic samples are coded by the principal investigator and sent to the oral pathologist who is unaware of the type of grafting material used. Data analysis is also performed by a statistician based on the provided codes.

There is no further information.