Clinical Performance Evaluation of Two Different Dental Implants

Edentulism Clinical Trial

— HAHy-vs-C  

Official title:

Clinical Performance Evaluation of a Hyaluronic Acid-coated Hybrid Dental Implant Compared to a Non-Coated Standard Rough Dental Implant: A Pragmatic Multi-center Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03845335
• Other study ID #: Protocol 01
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 25, 2019
• Est. completion date: July 2023

Study information

• Verified date: June 2022
• Source: Elite Odontoiatrica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In brief, the aim of this randomized controlled trial is to evaluate the patient satisfaction and the clinical performance of two types of implants: 1) HA-coated hybrid dental implant and 2) non-coated moderately rough dental implant. The comparison will be studied during a routine implant placement of experienced dental implantologists.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: July 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent to participate to the present investigation
• Psychological appropriateness and good compliance to dentist instructions
• Patient who have been selected for implant therapy by an experienced surgeon.

Related Conditions & MeSH terms

• Edentulism

Intervention

Device:
• dental implant-supported restoration
During the oral surgery session for dental implant insertion, after implant site preparation, the opaque sealed envelope containing the patient allocation will be opened. Following the group allocation, the patient will receive either an HA-coated Hybrid or moderately rough dental implant

Locations

Country	Name	City	State
Italy	Elite Odontoiatrica Caronno	Caronno Pertusella	VA
Italy	Elite Odontoiatrica Magenta	Magenta	MI
Italy	Elite Odontoiatrica Milano	Milano	MI
Italy	Elite Odontoiatrica Opera	Opera	MI

Sponsors (1)

Lead Sponsor	Collaborator
Elite Odontoiatrica

Country where clinical trial is conducted

Italy, 

References & Publications (7)

Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hämmerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957. — View Citation

de Bruyn H, Collaert B, Lindén U, Björn AL. Patient's opinion and treatment outcome of fixed rehabilitation on Brånemark implants. A 3-year follow-up study in private dental practices. Clin Oral Implants Res. 1997 Aug;8(4):265-71. — View Citation

Jung RE, Pjetursson BE, Glauser R, Zembic A, Zwahlen M, Lang NP. A systematic review of the 5-year survival and complication rates of implant-supported single crowns. Clin Oral Implants Res. 2008 Feb;19(2):119-30. Epub 2007 Dec 7. Review. — View Citation

Lang NP, Zitzmann NU; Working Group 3 of the VIII European Workshop on Periodontology. Clinical research in implant dentistry: evaluation of implant-supported restorations, aesthetic and patient-reported outcomes. J Clin Periodontol. 2012 Feb;39 Suppl 12:133-8. doi: 10.1111/j.1600-051X.2011.01842.x. — View Citation

Meijndert L, Meijer HJ, Stellingsma K, Stegenga B, Raghoebar GM. Evaluation of aesthetics of implant-supported single-tooth replacements using different bone augmentation procedures: a prospective randomized clinical study. Clin Oral Implants Res. 2007 Dec;18(6):715-9. Epub 2007 Sep 20. — View Citation

Pjetursson BE, Tan K, Lang NP, Brägger U, Egger M, Zwahlen M. A systematic review of the survival and complication rates of fixed partial dentures (FPDs) after an observation period of at least 5 years. Clin Oral Implants Res. 2004 Dec;15(6):625-42. Review. — View Citation

Pjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol. 2008 Sep;35(8 Suppl):216-40. doi: 10.1111/j.1600-051X.2008.01272.x. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival Rate	Cumulative implant survival rate	12 months after implant placement