Bone Density Clinical Trial
Official title:
A Clinical and Radiological Comparison of Osseodensification Versus Conventional Implant Site Preparation Protocol During Dental Implant Placement. A Randomised Controlled Clinical Trial
Verified date | December 2019 |
Source | Krishnadevaraya College of Dental Sciences & Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The present study is a human, prospective, randomised controlled clinical trial conducted to explore and compare the clinical and radiological outcome of Osseodensification protocol with conventional implant site preparation protocol. The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.
Status | Completed |
Enrollment | 22 |
Est. completion date | October 30, 2019 |
Est. primary completion date | October 15, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Single/multiple missing teeth in the maxillary anterior/posterior region. 2. Bone density of D2 or D3 (Carl E.Misch). 3. Patients between 18-75 years. 4. Patients who demonstrate good plaque control (PI<10%) and showing good compliance. 5. Patients willing to participate in the study. Exclusion Criteria:- 1. Insufficient density or height of residual ridge. 2. Patients with bleeding disorder or on anticoagulant therapy. 3. Pregnant and lactating females. 4. Patients with history of smoking. 5. Use of systemic antibiotics in the past 3 months. 6. Patients treated with any medication known to cause periodontal changes. 7. Drug and alcohol abuse. 8. Occlusal interferences. 9. Patients with history of titanium allergy. 10. Immunocompromised state and debilitating disease. 11. Malignancy or radiotherapy/chemotherapy for malignancy. 12. Systemic diseases that would negatively influence wound healing. |
Country | Name | City | State |
---|---|---|---|
India | Krishnadevaraya college of dental sciences | Bangalore | Karnataka |
Lead Sponsor | Collaborator |
---|---|
Krishnadevaraya College of Dental Sciences & Hospital |
India,
Alghamdi H, Anand PS, Anil S. Undersized implant site preparation to enhance primary implant stability in poor bone density: a prospective clinical study. J Oral Maxillofac Surg. 2011 Dec;69(12):e506-12. doi: 10.1016/j.joms.2011.08.007. — View Citation
Alifarag AM, Lopez CD, Neiva RF, Tovar N, Witek L, Coelho PG. Atemporal osseointegration: Early biomechanical stability through osseodensification. J Orthop Res. 2018 Sep;36(9):2516-2523. doi: 10.1002/jor.23893. Epub 2018 Mar 30. — View Citation
Almutairi AS, Walid MA, Alkhodary MA. The effect of osseodensification and different thread designs on the dental implant primary stability. F1000Res. 2018 Dec 5;7:1898. doi: 10.12688/f1000research.17292.1. eCollection 2018. — View Citation
Capparé P, Vinci R, Di Stefano DA, Traini T, Pantaleo G, Gherlone EF, Gastaldi G. Correlation between Initial BIC and the Insertion Torque/Depth Integral Recorded with an Instantaneous Torque-Measuring Implant Motor: An in vivo Study. Clin Implant Dent Re — View Citation
Falco A, Berardini M, Trisi P. Correlation Between Implant Geometry, Implant Surface, Insertion Torque, and Primary Stability: In Vitro Biomechanical Analysis. Int J Oral Maxillofac Implants. 2018 Jul/Aug;33(4):824-830. doi: 10.11607/jomi.6285. — View Citation
Huwais S, Meyer EG. A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):27-36. doi: 10.1 — View Citation
Lahens B, Lopez CD, Neiva RF, Bowers MM, Jimbo R, Bonfante EA, Morcos J, Witek L, Tovar N, Coelho PG. The effect of osseodensification drilling for endosteal implants with different surface treatments: A study in sheep. J Biomed Mater Res B Appl Biomater. — View Citation
Lahens B, Neiva R, Tovar N, Alifarag AM, Jimbo R, Bonfante EA, Bowers MM, Cuppini M, Freitas H, Witek L, Coelho PG. Biomechanical and histologic basis of osseodensification drilling for endosteal implant placement in low density bone. An experimental stud — View Citation
Lopez CD, Alifarag AM, Torroni A, Tovar N, Diaz-Siso JR, Witek L, Rodriguez ED, Coelho PG. Osseodensification for enhancement of spinal surgical hardware fixation. J Mech Behav Biomed Mater. 2017 May;69:275-281. doi: 10.1016/j.jmbbm.2017.01.020. Epub 2017 — View Citation
Markovic A, Calvo-Guirado JL, Lazic Z, Gómez-Moreno G, Calasan D, Guardia J, Colic S, Aguilar-Salvatierra A, Gacic B, Delgado-Ruiz R, Janjic B, MiĊĦic T. Evaluation of primary stability of self-tapping and non-self-tapping dental implants. A 12-week clinic — View Citation
Oliveira PGFP, Bergamo ETP, Neiva R, Bonfante EA, Witek L, Tovar N, Coelho PG. Osseodensification outperforms conventional implant subtractive instrumentation: A study in sheep. Mater Sci Eng C Mater Biol Appl. 2018 Sep 1;90:300-307. doi: 10.1016/j.msec.2 — View Citation
Slete FB, Olin P, Prasad H. Histomorphometric Comparison of 3 Osteotomy Techniques. Implant Dent. 2018 Aug;27(4):424-428. doi: 10.1097/ID.0000000000000767. — View Citation
Stavropoulos A, Cochran D, Obrecht M, Pippenger BE, Dard M. Effect of Osteotomy Preparation on Osseointegration of Immediately Loaded, Tapered Dental Implants. Adv Dent Res. 2016 Mar;28(1):34-41. doi: 10.1177/0022034515624446. — View Citation
Tian JH, Neiva R, Coelho PG, Witek L, Tovar NM, Lo IC, Gil LF, Torroni A. Alveolar Ridge Expansion: Comparison of Osseodensification and Conventional Osteotome Techniques. J Craniofac Surg. 2019 Mar/Apr;30(2):607-610. doi: 10.1097/SCS.0000000000004956. — View Citation
Trisi P, Berardini M, Falco A, Podaliri Vulpiani M. New Osseodensification Implant Site Preparation Method to Increase Bone Density in Low-Density Bone: In Vivo Evaluation in Sheep. Implant Dent. 2016 Feb;25(1):24-31. doi: 10.1097/ID.0000000000000358. — View Citation
Trisi P, Berardini M, Falco A, Podaliri Vulpiani M. Validation of value of actual micromotion as a direct measure of implant micromobility after healing (secondary implant stability). An in vivo histologic and biomechanical study. Clin Oral Implants Res. — View Citation
Witek L, Alifarag AM, Tovar N, Lopez CD, Gil LF, Gorbonosov M, Hannan K, Neiva R, Coelho PG. Osteogenic parameters surrounding trabecular tantalum metal implants in osteotomies prepared via osseodensification drilling. Med Oral Patol Oral Cir Bucal. 2019 — View Citation
Witek L, Neiva R, Alifarag A, Shahraki F, Sayah G, Tovar N, Lopez CD, Gil L, Coelho PG. Absence of Healing Impairment in Osteotomies Prepared via Osseodensification Drilling. Int J Periodontics Restorative Dent. 2019 Jan/Feb;39(1):65-71. doi: 10.11607/prd — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | primary implant stability | the primary implant stability was measured during implant placement using Insertion Torque Value(ITV). | immediate post implant placement | |
Primary | change from baseline in bone density | A Multislice CT was used for scanning the implant site pre operatively, just after implant placement and 1 year post implant placement to measure the change in bone density. It was performed using a tube voltage of 120 kV(kilovolt) and a tube current of 40 mA(milliampere). The occlusal plane of the patient was set perpendicular to the floor base using ear rods. The axial images was reconstructed with 0.625 mm thick slices at 0.625 mm interval and a 1.75 mm field of view(FOV) image analysis software | 1 year | |
Primary | change from baseline in crestal bone level | Digital radiographs (radiovisiograph-RVG) were standardised using radiographic paralleling technique and positioning device and custom fabricated bite-block at baseline and follow up.Mesial and distal peri-implant radiographic bone level were recorded in millimetres on the digital radiographs using Digimiser image | 1 year | |
Secondary | change from baseline in keratinized mucosa width | The width of keratinized mucosa was measured from the mucosal margin to the mucogingival junction at the facial surface. The mucogingival junction location was determined using a visual method (Schiller's potassium iodide solution). | 1 year | |
Secondary | change from baseline in ridge width | Soft tissue and hard tissue labio-lingual ridge width was measured at baseline, immediate post implant placement, 6 months and 1 year after implant placement using ridge mapping calipers/Multislice CT. | 1 year | |
Secondary | Patient reported pain evaluation (Visual Analog Scale) | patient were asked to report the pain after the procedure in terms of visual analog scale (VAS) score in a rating between 1 to 10. There are 5-point verbal descriptive scale with an interval of 2("nil," "mild," "moderate," "severe," and "very severe") Patients were asked to rate their pain in a score between 1-10 | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02399553 -
Effect of the Interaction Between the Type of Artificial Turf and Boots Model of Bone Health in Children Soccer Players
|
N/A | |
Completed |
NCT01059968 -
Low Energy Availability, Menstrual Irregularity, and Low Bone Mass
|
N/A | |
Completed |
NCT00838838 -
Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis
|
N/A | |
Not yet recruiting |
NCT04439097 -
Effects of Multicomponent Physical Exercise Program and Mediterranean Diet in Alzheimer's Disease
|
N/A | |
Active, not recruiting |
NCT03701789 -
Effect of Baricitinib Treatment on Peripheral Bone in RA
|
Phase 3 | |
Completed |
NCT04332679 -
Non-resorbable Membranes Versus Titanium Meshes and Resorbable Membranes
|
N/A | |
Completed |
NCT03292146 -
Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study
|
Phase 3 | |
Not yet recruiting |
NCT01407458 -
The Impact of a Structured Physical Activity Program on Bone Strength and Psycho-Motor Learning of Young Children
|
N/A | |
Completed |
NCT01019122 -
Longitudinal Assessment of Bone Growth in Children With Cerebral Palsy
|
N/A | |
Completed |
NCT04203212 -
BMD Alterations and Bone and Muscle Parameters During Menstrual Cessation With GnRH
|
||
Terminated |
NCT00822159 -
Influence of Bone Strength Measured by DensiProbe on Bone Related Fixation Failure
|
N/A | |
Completed |
NCT00420940 -
The Influence of Vibration on Bone Mineral Density in Women Who Have Weak Bones After Menopause
|
Phase 3 | |
Completed |
NCT00603551 -
Screening of Bone Mineral Density in Women Who Have Received Chemotherapy
|
||
Completed |
NCT04029779 -
Evaluation of Immediately Placed Dental Implants With Local Application of Injectable PRF in Periodontally Compromised Sites
|
Phase 2 | |
Completed |
NCT02655055 -
Bone Density in Voluntary Apheresis Blood Donors
|
N/A | |
Completed |
NCT02997033 -
SIBlos EXtension Study (SIBEX)
|
||
Completed |
NCT00809484 -
Arimidex Bone Mass Index and Oral Bisphosphonates
|
N/A | |
Recruiting |
NCT06320704 -
Occlusal Balance Effect on Mandibular Bone Density by Using Fractal Analysis in Complete Denture Patients (Split-Mouth Study)
|
||
Completed |
NCT00473031 -
The Effect of Weight Loss and Dietary Protein Intake on Bone
|
N/A | |
Active, not recruiting |
NCT00607516 -
Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Hemiarthroplasties
|
N/A |