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

NCT04343066 | Unknown FDA Device

• 1 other identifier: FMD195
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Implantation; Bone Remodeling

Keywords

Alveolar ridge augmentation; Dental implants; Marginal bone remodeling

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (6)

• Insertion torque

  During procedure

• Change of Clinical parameters from baseline to 1 year post-op

  During procedure, at 6 months and at 1 year

• Change of FMBS parameters from baseline to 1 year post-op

  During procedure, at 6 months and at 1 year

• Change of Keratinized tissue height from Baseline to 4 months

  During procedure and at 4 months

• Histological analysis

  During procedure

Study Arms (2)

External hex implant

EXPERIMENTAL

External hexagone implant connection

Device: Implant insertion

Internal hex implant

EXPERIMENTAL

Internal implant connection

Device: Implant insertion

Interventions

Implant insertion DEVICE

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.

Also known as: Radiological bone level

External hex implant; Internal hex implant

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint-Joseph University

Beirut, 1104 2020, Lebanon

Location

Related Publications (10)

• 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.

  PMID: 29401469 BACKGROUND

• 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.

  PMID: 24894890 BACKGROUND

• 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.

  PMID: 27224562 BACKGROUND

• 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. doi: 10.1034/j.1600-0501.1998.090102.x.

  PMID: 9590940 BACKGROUND

• 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. doi: 10.1590/s1678-77572012000500010.

  PMID: 23138742 BACKGROUND

• 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.

  PMID: 25048469 BACKGROUND

• Donati M, Ekestubbe A, Lindhe J, Wennstrom 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.

  PMID: 29569767 BACKGROUND

• 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.

  PMID: 11324207 BACKGROUND

• Zetterqvist L, Feldman S, Rotter B, Vincenzi G, Wennstrom 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.

  PMID: 20367092 BACKGROUND

• 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.

  PMID: 9558555 BACKGROUND

Study Officials

• Nada Naaman, PhD

  Saint-Joseph University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 13, 2020
• Study Start: April 15, 2019
• Primary Completion: November 30, 2019
• Study Completion: December 30, 2020
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 1 year from date of publication
• Access Criteria: Following a direct request, for meta-analysis or literature review report.

Locations

LE (1)