AzTrials
AzTrials

Dental ImplantationNCT04343066

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

A study testing Implant insertion in people with Dental Implantation and Bone Remodeling, run by Saint-Joseph University at 1 site in Lebanon.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Dental Implantation, Bone Remodeling
What is being tested?
Implant insertion
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteLebanon
Study dates
15 Apr 2019to 30 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Lebanon1 site

  • Saint-Joseph University

    Beirut, 1104 2020

Other trials in Lebanon

About this study

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

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.

Read the detailed 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.

Being tested
Implant insertion
Keywords
Alveolar ridge augmentation, Dental implants, Marginal bone remodeling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implant insertionDevice

    Also called Radiological bone level

    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.

Study groups in NCT04343066
Study groupRoleWhat they receive
External hex implantExperimentalExternal hexagone implant connection
Receives: Device: Implant insertion
Internal hex implantExperimentalInternal implant connection
Receives: Device: Implant insertion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline of alveolar ridge thickness at 4 months

    Peroperative surgical measurements of the alveolar ridge width at implant sites

    Measured: During procedure and at 4 months

  2. 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.

    Measured: During procedure and at 1 year

  3. 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

    Measured: During procedure, at 4 months, at 6 months and 1 year

  4. Change from baseline of bone plate thickness at 4 months

    Peroperative buccal and lingual residual bone thickness following implant insertion

    Measured: During procedure and at 4 months

Secondary outcomes (6)

  1. Insertion torque

    Manual torque insertion are registered at implant placement.

    Measured: During procedure

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

    FMBS, FMPS,

    Measured: During procedure, at 6 months and at 1 year

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

    Change in full mouth bleeding score

    Measured: During procedure, at 6 months and at 1 year

  4. Change of Keratinized tissue height from Baseline to 4 months

    Measured using a 1.0-mm marked periodontal probe

    Measured: During procedure and at 4 months

  5. 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

    Measured: During procedure

  6. Change of FMPS parameters from baseline to 1 year post-op

    Change in full mouth plaque score

    Measured: During procedure, at 6 months and at 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2020
  2. Study start15 Apr 2019
  3. Primary completion30 Nov 2019
  4. Study completion30 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04343066
Sponsor's protocol ID
FMD195
Status last verified
Oct 2020
First submitted
3 Apr 2020
Last updated
23 Oct 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: The outcome measurements and patients characteristics might be shared

Publications

  • 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.

    PubMed 29401469

  • 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.

    PubMed 24894890

  • 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.

    PubMed 27224562

  • 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.

    PubMed 9590940

  • 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.

    PubMed 23138742

  • 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.

    PubMed 25048469

  • 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.

    PubMed 29569767

  • 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.

    PubMed 11324207

  • 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.

    PubMed 20367092

  • 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.

    PubMed 9558555

Questions about this trial

What is this clinical trial studying?

A study testing Implant insertion in people with Dental Implantation and Bone Remodeling, run by Saint-Joseph University at 1 site in Lebanon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline of alveolar ridge thickness at 4 months (time frame: During procedure and at 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04343066, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.

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