NCT04017156

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

4 months

First QC Date

July 10, 2019

Last Update Submit

July 11, 2019

Conditions

Edentulous; Alveolar Process, Atrophy

Outcome Measures

Primary Outcomes (1)

  • New bone in contact with the implant surface

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

    After 8 weeks of healing

Secondary Outcomes (1)

  • Bone density around the implant surface

    After 8 weeks of healing

Other Outcomes (1)

  • pre-existing (old) bone, soft tissue (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and marrow spaces (soft tissue)

    After 8 weeks of healing

Study Arms (2)

Test site (torque of <10 Ncm)

EXPERIMENTAL

The test sites (\<10 Ncm) will be over-prepared with drills of larger diameter

Procedure: implant installation

Control site (torque of ~30 Ncm)

OTHER

the standard sites (\~30 Ncm)will be prepared with the corresponding drills suggested by the manufacturer

Procedure: implant installation

Interventions

implant installationPROCEDURE

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.

Also known as: implant surgery
Control site (torque of ~30 Ncm)Test site (torque of <10 Ncm)

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colombia

Cartagena, Cartagena, 5710, Colombia

Location

Related Publications (18)

  • 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.

    PMID: 21841994RESULT

  • 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.

    PMID: 25664701RESULT

  • 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.

    PMID: 24660204RESULT

  • 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.

    PMID: 20626423RESULT

  • 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.

    PMID: 24684411RESULT

  • 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.

    PMID: 24313303RESULT

  • 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.

    PMID: 26043651RESULT

  • 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.

    PMID: 29271785RESULT

  • 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.

    PMID: 29173997RESULT

  • 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.

    PMID: 20528892RESULT

  • 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.

    PMID: 24325598RESULT

  • 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.

    PMID: 29659124RESULT

  • 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.

    PMID: 27129002RESULT

  • 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.

    PMID: 17622014RESULT

  • 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.

    PMID: 19958375RESULT

  • Caneva M, Lang NP, Calvo Guirado JL, Spriano S, Iezzi G, Botticelli D. Bone healing at bicortically installed implants with different surface configurations. An experimental study in rabbits. Clin Oral Implants Res. 2015 Mar;26(3):293-9. doi: 10.1111/clr.12475. Epub 2014 Sep 15.

    PMID: 25220835RESULT

  • Ferri M, Lang NP, Angarita Alfonso EE, Bedoya Quintero ID, Burgos EM, Botticelli D. Use of sonic instruments for implant biopsy retrieval. Clin Oral Implants Res. 2015 Nov;26(11):1237-43. doi: 10.1111/clr.12466. Epub 2014 Aug 11.

    PMID: 25109369RESULT

  • Amari Y, Piattelli A, Apaza Alccayhuaman KA, Mesa NF, Ferri M, Iezzi G, Botticelli D. Bone healing at non-submerged implants installed with different insertion torques: a split-mouth histomorphometric randomized controlled trial. Int J Implant Dent. 2019 Dec 5;5(1):39. doi: 10.1186/s40729-019-0194-2.

    PMID: 31802302DERIVED

MeSH Terms

Conditions

Mouth, EdentulousAtrophy

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The two recipient sites will be selected prior the surgery, while the type of site preparation will be randomly decided. The randomization will be performed electronically (randomization.com) by a researcher neither involved in the selection of the patients nor in installation of the devices (DB). Sealed opaque envelopes will be prepared and opened at the time of surgery by an author not involved in the surgery (DB). Surgeon and patients will be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Clinical Trial
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 12, 2019

Study Start

July 20, 2016

Primary Completion

November 22, 2016

Study Completion

October 17, 2017

Last Updated

July 12, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Will be shared after publication

Locations

CO(1)