Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone

Dental Implantation Clinical Trial

Official title:

Clinical and Radiographic Evaluation of Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone: a 1-year Randomized Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04343066
• Other study ID #: FMD195
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: October 2020
• Source: Saint-Joseph University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this prospective controlled clinical trial is to evaluate the clinical and radiographical outcomes of two implant surfaces inserted in a crest that has been horizontally augmented at least 6 months prior to the implant placement. The horizontal GBR should be done with a xenogenic graft mixed with autologous bone particles, and a collagen membrane stabilized using tacks or screws.

Description:

This is a prospective, randomized clinical and radiographical evaluation of bone remodeling around implants with two different surfaces placed in a previously augmented crest. Patients requiring dental implants in previously horizontally augmented bone crest are recruited at the Department of Periodon¬tics, Faculty of dental medicine, Saint-Joseph University, Beirut, and will be treated with either T3 (contemporary hybrid collar), tapered, ex-hex, CP4 or Full Osseotite, tapered, ex-hex, CP4. A total of 30 implants will be placed (15 per group). Random allocation of implant type per site will be done by the sealed envelope method. The implants will be placed using a one-stage surgical approach. A final crown will be placed (screw-retained on multiunit abutment) between 3 and 4 months post-implant placement. The patients will be followed-up at 6 months and 1 year. Only patients meeting inclusion/exclusion criteria and providing a dated and signed informed consent form will be enrolled in the study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 30, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patient age: between 20 and 65
• No systematic contraindication for implant surgery
• No more than 10 cigarettes/day
• Previous horizontal bone augmentation 6 months prior to implant placement
• Adequate oral hygiene i.e. Full mouth bleeding score (FMBS) <20% and Full mouth plaque score (FMPS) < 20%)

Exclusion Criteria:

• Smokers more than 10 cigarettes/day
• Pregnant/lactating women
• Alcoholics/drug addicts
• Uncontrolled diabetics, immunocompromised, blood hemostasis problems
• Patients taking IV bisphosphonates or drugs affecting bone metabolism or mucosal healing
• Patients not willing to sign the consent form
• History of radiotherapy in the head and neck region in the last 5 years
• Active periodontitis on the remaining teeth

Related Conditions & MeSH terms

• Bone Remodeling
• Dental Implantation

Intervention

Device:
• Implant insertion
In both groups, the implants will be placed using a two-stage surgical approach at the crestal level in previously horizontally augmented bony sites. A final crown will be placed (screw-retained on multiunit abutment) between 3- and 4-months post-implant placement. Random allocation of implant type per site will be done by the sealed envelope method. Follow-up measurements will be done at 6 months and 1-year post-loading. The measurements are done by a blinded investigator. Before starting the study, the examiner will be trained in a calibration process. Exam sheets are kept confidential and anonymous. Inclusion criteria are: patient aged 20 to 65, no systematic contraindication for implant surgery, smoking < 10 cigarettes, previous horizontal bone augmentation, FMBS <20% and FMPS < 20%. Exclusion criteria are: general contraindication for implant surgery, pregnant/lactating women, uncontrolled diabetics, patients not willing to sign the consent form, active periodontitis.

Locations

Country	Name	City	State
Lebanon	Saint-Joseph University	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Saint-Joseph University

Country where clinical trial is conducted

Lebanon, 

References & Publications (10)

Donati M, Ekestubbe A, Lindhe J, Wennström JL. Marginal bone loss at implants with different surface characteristics - A 20-year follow-up of a randomized controlled clinical trial. Clin Oral Implants Res. 2018 May;29(5):480-487. doi: 10.1111/clr.13145. Epub 2018 Mar 23. — View Citation

Esposito M, Ardebili Y, Worthington HV. Interventions for replacing missing teeth: different types of dental implants. Cochrane Database Syst Rev. 2014 Jul 22;(7):CD003815. doi: 10.1002/14651858.CD003815.pub4. Review. — View Citation

Koller CD, Pereira-Cenci T, Boscato N. Parameters Associated with Marginal Bone Loss around Implant after Prosthetic Loading. Braz Dent J. 2016 May-Jun;27(3):292-7. doi: 10.1590/0103-6440201600874. — View Citation

Liu J, Kerns DG. Mechanisms of guided bone regeneration: a review. Open Dent J. 2014 May 16;8:56-65. doi: 10.2174/1874210601408010056. eCollection 2014. — View Citation

Nevins M, Mellonig JT, Clem DS 3rd, Reiser GM, Buser DA. Implants in regenerated bone: long-term survival. Int J Periodontics Restorative Dent. 1998 Feb;18(1):34-45. — View Citation

Rosa MB, Albrektsson T, Francischone CE, Schwartz Filho HO, Wennerberg A. The influence of surface treatment on the implant roughness pattern. J Appl Oral Sci. 2012 Sep-Oct;20(5):550-5. — View Citation

Shi JY, Jie-Ni, Zhuang LF, Zhang XM, Fan LF, Lai HC. Peri-implant conditions and marginal bone loss around cemented and screw-retained single implant crowns in posterior regions: A retrospective cohort study with up to 4 years follow-up. PLoS One. 2018 Feb 5;13(2):e0191717. doi: 10.1371/journal.pone.0191717. eCollection 2018. — View Citation

Testori T, Wiseman L, Woolfe S, Porter SS. A prospective multicenter clinical study of the Osseotite implant: four-year interim report. Int J Oral Maxillofac Implants. 2001 Mar-Apr;16(2):193-200. — View Citation

Wennerberg A, Hallgren C, Johansson C, Danelli S. A histomorphometric evaluation of screw-shaped implants each prepared with two surface roughnesses. Clin Oral Implants Res. 1998 Feb;9(1):11-9. — View Citation

Zetterqvist L, Feldman S, Rotter B, Vincenzi G, Wennström JL, Chierico A, Stach RM, Kenealy JN. A prospective, multicenter, randomized-controlled 5-year study of hybrid and fully etched implants for the incidence of peri-implantitis. J Periodontol. 2010 Apr;81(4):493-501. doi: 10.1902/jop.2009.090492. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of alveolar ridge thickness at 4 months	Peroperative surgical measurements of the alveolar ridge width at implant sites	During procedure and at 4 months
Primary	Change from baseline of radiographic bone level on CBCT at 1 year post-op	CBCT for buccal bone thickness measurements of the bone crest width at the implant site.	During procedure and at 1 year
Primary	Change from baseline of radiographic bone level assessment at 1 year post-op, on periapical x-ray	Radiographic measurements on standardized periapical radiograph of the bone dimensions, for interproximal bone remodeling, from the shoulder of the implant (reference point), to the coronal bone to implant contact	During procedure, at 4 months, at 6 months and 1 year
Primary	Change from baseline of bone plate thickness at 4 months	Peroperative buccal and lingual residual bone thickness following implant insertion	During procedure and at 4 months
Secondary	Insertion torque	Manual torque insertion are registered at implant placement.	During procedure
Secondary	Change of Clinical parameters from baseline to 1 year post-op	FMBS, FMPS,	During procedure, at 6 months and at 1 year
Secondary	Change of FMBS parameters from baseline to 1 year post-op	Change in full mouth bleeding score	During procedure, at 6 months and at 1 year
Secondary	Change of Keratinized tissue height from Baseline to 4 months	Measured using a 1.0-mm marked periodontal probe	During procedure and at 4 months
Secondary	Histological analysis	Bone core taken with a 2mm trephine bur at the site of implant placement for non-demineralized histological assessment of regenerated bone quality	During procedure
Secondary	Change of FMPS parameters from baseline to 1 year post-op	Change in full mouth plaque score	During procedure, at 6 months and at 1 year