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

Edentulous; Alveolar Process, Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04017156
• Other study ID #: protocol #04-2014
• Status: Completed
• Phase: N/A
• Start date: July 20, 2016
• Est. completion date: October 17, 2017

Study information

• Verified date: July 2019
• Source: ARDEC Academy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 17, 2017
• Est. primary completion date: November 22, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Presence of systemic disorders

• Chemotherapy or radiotherapy;

• Smokers >10 cigarettes per day

• Previous bone augmentation procedures in the region

Related Conditions & MeSH terms

• Atrophy
• Edentulous; Alveolar Process, Atrophy

Intervention

Procedure:
• implant installation
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.

Locations

Country	Name	City	State
Colombia	Colombia	Cartagena de Indias	Cartagena

Sponsors (1)

Lead Sponsor	Collaborator
ARDEC Academy

Country where clinical trial is conducted

Colombia, 

References & Publications (17)

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. — View Citation

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. — View Citation

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: — View Citation

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. — View Citation

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 st — View Citation

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):877-8 — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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 Den — View Citation

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 — View Citation

Rea M, Botticelli D, Ricci S, Soldini C, González 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 — View Citation

Rea M, Lang NP, Ricci S, Mintrone F, González González 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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Verrastro Neto A, Andrade R, Corrêa 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 — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pre-existing (old) bone, soft tissue (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and marrow spaces (soft tissue)	The percentages of pre-existing (old) bone, soft tissue (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and marrow spaces (soft tissue) will be evaluated all in contact with the implant surface	After 8 weeks of healing
Primary	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	Bone density around the implant surface	The total mineralized bone will be assessed as sum of new and old bone	After 8 weeks of healing