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Edentulous Alveolar RidgeNCT03714139

Immediate Loading a Histological Study

A study testing immediate loading and non implant loading in people with Edentulous Alveolar Ridge, run by ARDEC Academy at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Twelve participants with edentulous alveolar crests in the distal portion of the arches will be included in the study. At least two implant sites will be identified in each patient and will be sub-prepared with drills or sonic instruments. Read more about this study

Who is it for?
Ages 25 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Edentulous Alveolar Ridge
What is being tested?
immediate loading and non implant loading
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteColombia
Study dates
3 Mar 2018to 28 Feb 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 25 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult participants (≥25 years of age) with the need of at least two implants to replace teeth of the jaw will be included.
  • Natural antagonist teeth have to be present both at test and control sites to guarantee occlusal contacts

Who cannot join

  • untreated rampant caries or uncontrolled periodontal disease of the remaining teeth
  • diabetes not controlled diabetes or any other systemic or local disease that could compromise postoperative healing and / or osseointegration
  • need for systemic corticosteroids or any other medication that could compromise postoperative healing and / or osseointegration
  • inability or unwillingness to return to follow-up not likely to be able to comply with the study procedures according to the judgment of the investigators
  • pregnancy

Trial locations and contacts

1 site in 1 country.

Colombia1 site

  • Colombia

    Cartagena, Cartagena, 5710

Other trials in Colombia

About this study

Official title: Immediate Loading-A Histological Study in Humans

Twelve participants with edentulous alveolar crests in the distal portion of the arches will be included in the study. At least two implant sites will be identified in each patient and will be sub-prepared with drills or sonic instruments. One site will be used as a test and one as a control where experimental mini-implants will be installed. Reconstructive surgical procedures will be applied at the biopsy sites.

Read the detailed description

Objective: - To evaluate histologically the influence of the functional load on implants, both immediate and delayed.

Material and methods: 12 participants with edentulous alveolar crests in the distal portion of the arches will be included in the study. At least two implant sites will be identified in each patient and will be sub-prepared with drills or sonic instruments to obtain a high degree of torque to ensure optimum primary stability. At least one site will be used as a test and one as a control where experimental mini-implants will be installed. Test sites will be loaded immediately. The control sites will remain unloaded. After 2 months, mini-implants will be recovered as planned for each group. Reconstructive surgical procedures will be applied at the biopsy sites, if necessary, using autologous bone or bone substitutes and membranes. Standard implants will be installed during the same surgical session and, after 2 months, the planned prosthesis will be performed. Patients will be followed for at least 2 years for evaluation and intervention, if necessary.

Biopsies will be included in resin to obtain wear cuts for histomorphometric analysis. The bone histomorphometry will be evaluated and statistical analysis will be carried out.

Being tested
immediate loading, non implant loading
Keywords
Dental Implants, bone healing, clinical trial, histology

What participants receive

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

  • immediate loadingProcedure or surgery

    Also called implant surgery, prosthesis

    The participants will be assigned to immediate or delayed functional loading groups. In each participant, edentulous areas with adequate thickness of the alveolar bone crest will be identified and at least two sites will be identified for implant installation. All implant recipient sites will be sub-prepared to allow good stability of the implants. Experimental mini-implants (Sweden \& Martina, Due Carrare, Padova, Italy), 3.5 mm in diameter and with an intraosseous portion of 4 mm in length will be installed.

    Immediate loading group - A prosthetic component will be applied over the trial implants. Impressions will be taken and a crown / bridge will be provided to patients in one day.

  • non implant loadingProcedure or surgery

    Also called control site

    Control implants will receive a healing screw and will remain unloaded

Study groups in NCT03714139
Study groupRoleWhat they receive
Immediate implant LoadingExperimentalImmediate loading is defined as the placement of the implant and immediate prosthetic restoration
Receives: Procedure: immediate loading; Procedure: non implant loading
non implant loadingNo interventionthere is not immediate prosthetic restoration

What is being measured

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

  1. bone to implant contact

    The linear distances between IS and B (IS-B) and CM and X (CM-X) were measured parallel to the long axis of the implant at both sides of the implant at a magnification of x100.

    Moreover, the amount of new bone, old bone, total bone (new + old bone = BIC%

    Measured: 2 months

Secondary outcomes (1)

  1. Bone density

    The total amount of mineralized bone in contact with the implant surface measured histomorphometrically

    Measured: 2 months

Timeline

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

  1. First posted22 Oct 2018
  2. Study start3 Mar 2018
  3. Primary completion30 Jan 2019
  4. Study completion28 Feb 2020

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Split mouth, At least one site will be used as a test and one as a control where experimental mini-implants will be installed.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03714139
Sponsor's protocol ID
dental implants
Status last verified
Sep 2020
First submitted
17 Oct 2018
Last updated
5 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: there is a plan to save all the data to do the follow up

Publications

  • Bousdras VA, Walboomers F, Jansen JA, Cunningham JL, Blunn G, Petrie A, Jaecques S, Naert IE, Sindet-Pedersen S, Goodship AE. Immediate functional loading of single-tooth TiO2 grit-blasted implant restoration. A controlled prospective study in a porcine model. Part II: Histology and histomorphometry. Clin Implant Dent Relat Res. 2007 Dec;9(4):207-16. doi: 10.1111/j.1708-8208.2007.00039.x.

    PubMed 18031442

  • Calandriello R, Tomatis M, Vallone R, Rangert B, Gottlow J. Immediate occlusal loading of single lower molars using Branemark System Wide-Platform TiUnite implants: an interim report of a prospective open-ended clinical multicenter study. Clin Implant Dent Relat Res. 2003;5 Suppl 1:74-80. doi: 10.1111/j.1708-8208.2003.tb00018.x.

    PubMed 12691653

  • Cecchinato D, Bressan EA, Toia M, Araujo MG, Liljenberg B, Lindhe J. Osseointegration in periodontitis susceptible individuals. Clin Oral Implants Res. 2012 Jan;23(1):1-4. doi: 10.1111/j.1600-0501.2011.02293.x. Epub 2011 Nov 1.

    PubMed 22092689

  • Degidi M, Petrone G, Lezzi G, Piattelli A. Histologic evaluation of 2 human immediately loaded and 1 titanium implants inserted in the posterior mandible and submerged retrieved after 6 months. J Oral Implantol. 2003;29(5):223-9. doi: 10.1563/1548-1336(2003)0292.3.CO;2.

    PubMed 14620684

  • Degidi M, Piattelli A, Shibli JA, Perrotti V, Iezzi G. Bone formation around immediately loaded and submerged dental implants with a modified sandblasted and acid-etched surface after 4 and 8 weeks: a human histologic and histomorphometric analysis. Int J Oral Maxillofac Implants. 2009 Sep-Oct;24(5):896-901.

    PubMed 19865630

  • Degidi M, Scarano A, Petrone G, Piattelli A. Histologic analysis of clinically retrieved immediately loaded titanium implants: a report of 11 cases. Clin Implant Dent Relat Res. 2003;5(2):89-93. doi: 10.1111/j.1708-8208.2003.tb00189.x.

    PubMed 14536043

  • Bosshardt DD, Salvi GE, Huynh-Ba G, Ivanovski S, Donos N, Lang NP. The role of bone debris in early healing adjacent to hydrophilic and hydrophobic implant surfaces in man. Clin Oral Implants Res. 2011 Apr;22(4):357-64. doi: 10.1111/j.1600-0501.2010.02107.x.

    PubMed 21561477

Questions about this trial

What is this clinical trial studying?

A study testing immediate loading and non implant loading in people with Edentulous Alveolar Ridge, run by ARDEC Academy at 1 site in Colombia.

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 2 inclusion and 5 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: finished, as of the sponsor's last update on 5 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 Colombia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

bone to implant contact (time frame: 2 months). 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 NCT03714139, which also lists 7 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 5 Oct 2020.

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Immediate Loading a Histological Study (NCT03714139) | AzTrials