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Edentulous; Alveolar Process, AtrophyNCT04017156

Bone Healing at Non-submerged Implants Installed With Different Insertion Torques.

A study testing implant installation in people with Edentulous; Alveolar Process, Atrophy, 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

The objective of the study is to evaluate histomorphometrically the healing at implants installed with standard or very low insertion torque values. 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 Process, Atrophy
What is being tested?
implant installation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteColombia
Study dates
20 Jul 2016to 17 Oct 2017
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

  • presence of at least two edentulous zone in the posterior segment of the mandible
  • ≥ 25 years of age
  • smoking ≤ 10 cigarettes per day
  • Good general health
  • No contraindication for oral surgical procedures.
  • Not being pregnant.

Who cannot join

  • Presence of systemic disorders
  • Chemotherapy or radiotherapy;
  • Smokers >10 cigarettes per day
  • Previous bone augmentation procedures in the region

Trial locations and contacts

1 site in 1 country.

Colombia1 site

  • Colombia

    Cartagena, Cartagena, 5710

Other trials in Colombia

About this study

Official title: Bone Healing at Non-submerged Implants Installed With Different Insertion Torques. A Split Mouth Histomorphometric Randomized Controlled Trial.

The objective of the study is to evaluate histomorphometrically the healing at implants installed with standard or very low insertion torque values.

Read the detailed description

Very high insertion torque values have been recommended when immediate loading is applied to implants.1 However, it has been shown that similar clinical outcomes may be achieved even with insertion torque values ≤15 Ncm when implants are splinted together. Due to the contradictory outcomes on the influence of the torque on osseointegration and a lack of histological data in humans, there is a need of more evidences that may support the clinicians in the decision making when an unintentional low insertion torque occur at implants during the daily practice. So the aim of the study i evaluate histomorphometrically the healing at implants installed in Twelve volunteer patients that will be recruited. Two screw-shaped titanium devices will be installed in the distal segments of the mandible using insertion torque values of either <10 Ncm or ~30 Ncm. The implants were left to heal in a non-submerged fashion. After 8 weeks, biopsies will be retrieved and ground sections will be prepared for histological evaluation.

Being tested
implant installation
Medical subject headings
Mouth, Edentulous, Atrophy

What participants receive

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

  • implant installationProcedure or surgery

    Also called implant surgery

    All site preparations will be performed deeper compared to the length of the implant so that the implant apex cannot reach the bottom of the osteotomy.

Study groups in NCT04017156
Study groupRoleWhat they receive
Test site (torque of <10 Ncm)ExperimentalThe test sites (<10 Ncm) will be over-prepared with drills of larger diameter
Receives: Procedure: implant installation
Control site (torque of ~30 Ncm)Otherthe standard sites (~30 Ncm)will be prepared with the corresponding drills suggested by the manufacturer
Receives: Procedure: implant installation

What is being measured

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

  1. New bone in contact with the implant surface

    The percentages of new bone will be evaluated both in contact with the implant surface

    Measured: After 8 weeks of healing

Secondary outcomes (1)

  1. Bone density around the implant surface

    The total mineralized bone will be assessed as sum of new and old bone

    Measured: After 8 weeks of healing

Timeline

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

  1. First posted12 Jul 2019
  2. Study start20 Jul 2016
  3. Primary completion22 Nov 2016
  4. Study completion17 Oct 2017

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
Model description
Clinical Trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04017156
Sponsor's protocol ID
protocol #04-2014
Status last verified
Jul 2019
First submitted
10 Jul 2019
Last updated
12 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Will be shared after publication

Publications

  • Trisi P, Todisco M, Consolo U, Travaglini D. High versus low implant insertion torque: a histologic, histomorphometric, and biomechanical study in the sheep mandible. Int J Oral Maxillofac Implants. 2011 Jul-Aug;26(4):837-49.

    PubMed 21841994

  • Cesaretti G, Botticelli D, Renzi A, Rossi M, Rossi R, Lang NP. Radiographic evaluation of immediately loaded implants supporting 2-3 units fixed bridges in the posterior maxilla: a 3-year follow-up prospective randomized controlled multicenter clinical study. Clin Oral Implants Res. 2016 Apr;27(4):399-405. doi: 10.1111/clr.12565. Epub 2015 Feb 9.

    PubMed 25664701

  • Gallucci GO, Benic GI, Eckert SE, Papaspyridakos P, Schimmel M, Schrott A, Weber HP. Consensus statements and clinical recommendations for implant loading protocols. Int J Oral Maxillofac Implants. 2014;29 Suppl:287-90. doi: 10.11607/jomi.2013.g4. No abstract available.

    PubMed 24660204

  • Pantani F, Botticelli D, Garcia IR Jr, Salata LA, Borges GJ, Lang NP. Influence of lateral pressure to the implant bed on osseointegration: an experimental study in dogs. Clin Oral Implants Res. 2010 Nov;21(11):1264-70. doi: 10.1111/j.1600-0501.2010.01941.x.

    PubMed 20626423

  • Rea M, Lang NP, Ricci S, Mintrone F, Gonzalez Gonzalez G, Botticelli D. Healing of implants installed in over- or under-prepared sites--an experimental study in dogs. Clin Oral Implants Res. 2015 Apr;26(4):442-446. doi: 10.1111/clr.12390. Epub 2014 Mar 31.

    PubMed 24684411

  • Rea M, Botticelli D, Ricci S, Soldini C, Gonzalez GG, Lang NP. Influence of immediate loading on healing of implants installed with different insertion torques--an experimental study in dogs. Clin Oral Implants Res. 2015;26(1):90-5. doi: 10.1111/clr.12305. Epub 2013 Dec 9.

    PubMed 24313303

  • Barone A, Alfonsi F, Derchi G, Tonelli P, Toti P, Marchionni S, Covani U. The Effect of Insertion Torque on the Clinical Outcome of Single Implants: A Randomized Clinical Trial. Clin Implant Dent Relat Res. 2016 Jun;18(3):588-600. doi: 10.1111/cid.12337. Epub 2015 Jun 5.

    PubMed 26043651

  • Verardi S, Swoboda J, Rebaudi F, Rebaudi A. Osteointegration of Tissue-Level Implants With Very Low Insertion Torque in Soft Bone: A Clinical Study on SLA Surface Treatment. Implant Dent. 2018 Feb;27(1):5-9. doi: 10.1097/ID.0000000000000714.

    PubMed 29271785

  • Verrastro Neto A, Andrade R, Correa MG, Casarin RCV, Casati MZ, Pimentel SP, Ribeiro FV, Cirano FR. The impact of different torques for the insertion of immediately loaded implants on the peri-implant levels of angiogenesis- and bone-related markers. Int J Oral Maxillofac Surg. 2018 May;47(5):651-657. doi: 10.1016/j.ijom.2017.11.001. Epub 2017 Nov 23.

    PubMed 29173997

  • Duyck J, Corpas L, Vermeiren S, Ogawa T, Quirynen M, Vandamme K, Jacobs R, Naert I. Histological, histomorphometrical, and radiological evaluation of an experimental implant design with a high insertion torque. Clin Oral Implants Res. 2010 Aug;21(8):877-84. doi: 10.1111/j.1600-0501.2010.01895.x. Epub 2010 Apr 30.

    PubMed 20528892

  • Duyck J, Roesems R, Cardoso MV, Ogawa T, De Villa Camargos G, Vandamme K. Effect of insertion torque on titanium implant osseointegration: an animal experimental study. Clin Oral Implants Res. 2015 Feb;26(2):191-6. doi: 10.1111/clr.12316. Epub 2013 Dec 11.

    PubMed 24325598

  • Muktadar AK, Gangaiah M, Chrcanovic BR, Chowdhary R. Evaluation of the effect of self-cutting and nonself-cutting thread designed implant with different thread depth on variable insertion torques: An histomorphometric analysis in rabbits. Clin Implant Dent Relat Res. 2018 Aug;20(4):507-514. doi: 10.1111/cid.12611. Epub 2018 Apr 16.

    PubMed 29659124

  • Berardini M, Trisi P, Sinjari B, Rutjes AW, Caputi S. The Effects of High Insertion Torque Versus Low Insertion Torque on Marginal Bone Resorption and Implant Failure Rates: A Systematic Review With Meta-Analyses. Implant Dent. 2016 Aug;25(4):532-40. doi: 10.1097/ID.0000000000000422.

    PubMed 27129002

  • Balshi SF, Wolfinger GJ, Balshi TJ. A retrospective analysis of 44 implants with no rotational primary stability used for fixed prosthesis anchorage. Int J Oral Maxillofac Implants. 2007 May-Jun;22(3):467-71.

    PubMed 17622014

  • Rodrigo D, Aracil L, Martin C, Sanz M. Diagnosis of implant stability and its impact on implant survival: a prospective case series study. Clin Oral Implants Res. 2010 Mar;21(3):255-61. doi: 10.1111/j.1600-0501.2009.01820.x. Epub 2009 Dec 4.

    PubMed 19958375

Questions about this trial

What is this clinical trial studying?

A study testing implant installation in people with Edentulous; Alveolar Process, Atrophy, 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 6 inclusion and 4 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 12 Jul 2019. 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?

New bone in contact with the implant surface (time frame: After 8 weeks of healing). 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 NCT04017156, which also lists 18 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 12 Jul 2019.

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