RCT With 3 Different Biomaterials for Maxillary Sinus Lift

Maxillary Sinus Augmentation With Three Different Biomaterials: Histologic, Histomorphometric, Clinical and Patient Reported Outcomes From a Randomized Controlled Trial

Background: Lateral maxillary sinus augmentation (MSA) is a predictable bone regeneration technique in case of atrophy of the posterior-upper maxilla. Aimed at obtaining quantity and quality of bone suitable for receiving osseointegrated implants, its success is largely due to the skill of the surgeon, but also to the characteristics of the biomaterial used.

Methods: Twenty-four patients needing MSA were included in the study. The patients were randomly allocated to 3 different groups: Anorganic Bovine Bone Mineral (ABBM) as control, Tricalcium Phosphate (TCP) with or without hyaluronic acid (HA) as test groups. Nine months after MSA bone biopsies were harvested for the histomorphometric analysis. Secondary outcomes were mean bone gain, intraoperative and post-operative complications, implant insertion torque, implant failure and patient related outcome measures (PROMs).

Study Overview

• Status: Completed
• Conditions: Alveolar Bone Atrophy
• Intervention / Treatment: Procedure: Maxillary Sinus Augmentation; Device: Maxillary Sinus Graft with ABBM; Device: Maxillary Sinus Graft with TCP; Device: Maxillary Sinus Graft with TCP + HA

Detailed Description

The implant-prosthetic rehabilitation of the atrophic maxilla requires the creation of sufficient volumetric quantity of bone, through regeneration techniques, necessary to position the implants.

Maxillary sinus augmentation (MSA) is probably the most predictable and best performing technique.

The present randomized controlled study aims to evaluate and compare, histomorphometrically and clinically three different bone substitutes such as: ABBM, Tricalcium Phosphate (TCP) with or without the addition of hyaluronic acid (HA) that were used for lateral MSA. This study population will be followed until the 3rd year. This study describes histological differences between the three groups at 9 months.

All the patients enrolled in the study received a session of oral hygiene and a periodontal examination before the surgical procedure to obtain a more favorable oral environment for wound healing. A CBCT was mandatory for all included cases to verify that the maxillary sinus was clear and that the residual bone height was 3 mm or less. All the enrolled patients received 2 gr. of amoxicillin and clavulanic acid (or 600 mg. of clindamycin for those who were allergic to penicillins) as a pre-medication one-hour before surgery. All patients rinsed for 1 minute with 0.2% chlorhexidine mouthwash (and twice a day for the following 3 weeks). Local anesthesia was administered, a mid-crestal incision with mesial and distal release were performed to access the lateral bone wall of the maxillary sinus, subsequently, ultrasound bone surgery (Piezosurgery ®, Carasco, Italy) with specific tips was used for the bone window osteotomy (Figure 1-A). The Schneiderian membrane was reflected and lifted up medially with flat sinus curettes. Once the sinus membrane was completely lifted a bioabsorbable pericardium membrane (Smartbrane, Regedent AG, Zurich, Switzerland) was applied to protect it (Figure 1-B). The randomization sealed envelopes were opened and the clinician allocated the patients to one of the three experimental groups:

1. Control group that received Demineralized Bovine Bone Mineral (Bio-Oss Cancellous, Geistlich, Wolhunsen, Switzerland);
2. Test group 1 that received TCP with particle size ranging from 250 to 1000 µm (Osopia, Regedent, Zurich, Switzerland);
3. Test group 2 that received TCP as in test group1 plus crosslinked Hyaluronic Acid (Hyadent BG, Regedent, Zurich, Switzerland) with a ratio 2 to 1.

the bony window was repositioned, stabilized and covered with a resorbable pericardium membrane. Nine months after the MSA a CBCT analysis was required to evaluate the total bone height gain.

Depending on the treatment plan, between one and three implants, bone level (BL) or tissue level (TL), of two different manufacturers (Institut Straumann AG, Basel, Switzerland and Sweden & Martina, Due Carrare, Italy) were positioned. While preparing the osteotomy implant site a bone biopsy was harvested using a trephine. The implant insertion torque was measured in Ncm for each implant.

All patients were prescribed 1gr amoxicillin + clavulanic acid twice daily for 7 days (for those who were allergic to penicillin 300mg clindamycin 3 times daily for 7 days) as post-operative prophylaxis. All patients received 8mg of dexamethasone immediately after surgery and 4 mg of dexamethasone per day were prescribed for the following 5 days. Analgesics were prescribed (1gr paracetamol 3 times daily) according to patients' need. The use of removable temporary restorations was not recommended during the healing period.

After an osseointegration period of 3 months, the implants were restored. The prosthetic procedures were similar for all groups, impressions were taken with a polyether rubber material (Impregum, Espe Dental AG, Seefeld, Germany) and a customized impression tray. Final Zirconia screw-retained restorations were delivered after a period of 2/3 weeks, peri-apical radiographs were taken and oral hygiene instructions were given to all participants in the study.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • University of Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• need for maxillary sinus augmentation
• 18 years or older
• residual ridge height less than 3mm

Exclusion Criteria:

• full contraindication to implant surgery,
• systemic diseases that could negatively influence wound healing;
• heavy smokers (more than 10 cigarettes/day);
• head and neck irradiation treatment;
• uncontrolled diabetes;
• chronic or acute sinus pathology;
• uncontrolled periodontal disease;
• full mouth plaque and bleeding score higher than 25%,
• tooth extractions in the previous 2 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; patients in the control group received Demineralized Bovine Bone Mineral for the maxillary sinus augmentation	Procedure: Maxillary Sinus Augmentation; Biomaterial Graft into the Maxillary Sinus; Device: Maxillary Sinus Graft with ABBM; The maxillary sinuses in the control group are grafted with ABBM; Other Names: Anorganic Bovine Bone Mineral (ABBM)
Experimental: Test group 1; patients in the test group 1 received TCP with particle size from 250 to 1000 µm	Procedure: Maxillary Sinus Augmentation; Biomaterial Graft into the Maxillary Sinus; Device: Maxillary Sinus Graft with TCP; The maxillary sinuses in the test1 group are grafted with TCP; Other Names: Tricalcium Phosphate (TCP)
Experimental: Test group 2; patients in the test group 2 received TCP as in test group1 plus crosslinked Hyaluronic Acid	Procedure: Maxillary Sinus Augmentation; Biomaterial Graft into the Maxillary Sinus; Device: Maxillary Sinus Graft with TCP + HA; The maxillary sinuses in the test1 group are grafted with TCP + HA; Other Names: hyaluronic acid (HA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histomorphometric parameters of the augmented bone (descriptive)	Descriptive analysis of the specimen section at the microscope	9 months
Histomorphometric parameters of the augmented bone (% of new bone, marrow, graft)	Percentages of newly formed bone, marrow spaces and residual graft particles are reported.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean bone gain measured at 9 months through CBCT evaluation	radiographic evaluation	9 months
Intra-operative	clinical evaluation (yes/no) of the presence or occurrence of: sinus membrane perforation, excessive bleeding, lateral sinus cortical bone fracture.	During surgery
Post-operative complications	clinical evaluation (yes/no) of the presence or occurrence of:symptoms of acute sinusitis, swelling, suppuration, bleeding, trismus, hematoma, wound dehiscence, acute infections.	one week
Post-operative complications	clinical evaluation (yes/no) of the presence or occurrence of:symptoms of chronic sinusitis, swelling, suppuration, wound dehiscence, acute infections.	9 months
Implant insertion torque measured in Ncm	clinical evaluation	9 months
Early implant failure	clinical evaluation of the osseointegration of the implant into the bone (yes/no)	12 months
Patient reported outcome measures	All patients will answer a questionnaire regarding the oral health-related quality of life using the 14 questions of the short-form Oral Health Impact Profile (OHIP-14) (This questionnaire consists of 14 questions each one formulated in the following way: "How often (impact item) because of problems with your teeth, mouth or dentures?" The impact items belong to 7 different impact domains: 1. Functional limitations; 2. Physical pain; 3. Psychological discomfort; 4. Physical disability; 5. Psychological disability; 6. Social disability; 7. Handicap. Each question can be answered with a score from 0 to 4 corresponding to: 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, and 4 = very often.)	9 months

Collaborators and Investigators

• Sponsor: University of Pisa
• Investigators: Study Chair: Nicola A Valente, DDS, MS, University of Seville, Spain

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2017
• Primary Completion (Actual): June 29, 2019
• Study Completion (Actual): December 14, 2019

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): August 10, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Osseointegration; Implantology; Bone regeneration; Biomaterial(s)
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: SinusAug

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No