- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06412380
Influence of Insertion Torque and Bone Type on Post-operative Pain
Influence of High Insertion Torque and Type of Bone on Post-operative Pain and Survival Rate of Dental Implants
Study Overview
Status
Intervention / Treatment
Detailed Description
This prospective clinical study included 230 patients treated with a single tapered screw implant (Bioinnovation Dental®, Brazil). The implants were placed using the appropriate burs with a final master drill of 3.5 or 4.5 mm in diameter by one senior oral surgeon. These implants were multi-threaded, and their surfaces were both sandblasted and acid etched. Of the 230 participants, 172 received a single 5 x 10-mm implant, and 58 received a 4 x 10-mm implant.
For the higher torque range (90 - 200 Ncm), the maximum IT was recorded with an electronic digital torque measuring device (Tohnichi BTGE200CN-G, Hitachi, Japan), while a different gauge (Tohnichi BTG90CN-S, Hitachi, Japan) was used for the lower torque range (10 - 90 Ncm). All implants were placed at the crestal level and closed with a cover screw, and the flap was then sutured with non-resorbable 4/0 nylon suture (Resorba® Germany).
Pain levels were recorded at day 1, 2 and 4 and at week 1, 2 and 3 after surgery using visual analog scale (VAS) ranging from 0 "no pain" to 10 "worst pain ever. Implants were classified into 4 groups based on the IT value; Low: 60 implants (10-29 Ncm, mean=15 Ncm); Regular: 102 implants (30-50 Ncm, mean=42 Ncm); High: 47 implants (51-100 Ncm, mean=75 Ncm); and Very high: 21 implants (101-200 Ncm, mean=170 Ncm).
Implant survival was assessed clinically and radiographically at 3, 6, 12, 24 and 36 months. The criteria for implant success according to Buser et al, were no radiolucent zone around the implant, confirmed individual implant stability, and no suppuration, pain or ongoing pathologic processes. All implants that failed to fulfill these success criteria were regarded as failures.
The effect of IT, bone type, implant location, age, gender and smoking was measured with regression analysis. Kaplan-Meier survival analysis was performed to calculate the overall implant survival probabilities. The level of statistical significance was set at p<0.05.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sharjah, United Arab Emirates, 7724
- University of Sharjah
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: partially edentulous patients who presented with one or more missing teeth in the maxillary or mandibular jaw, at least18 years old, adequate oral hygiene, absence of infection or periodontal problems adjacent to the implant site, and sufficient bone thickness with a minimum 6-mm width and 12-mm length to accommodate implants of 4 or 5 mm in diameter and 10 mm in length.
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Exclusion Criteria: uncontrolled diabetes, hypertension, pregnancy, bone diseases, use of bisphosphonates, heavy smoker (more than 20 cigarettes /day), severe alcohol or drug use, patients with recent extraction of teeth and patients requiring bone and soft tissue augmentation procedures.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: The magnitude of insertion torque
Implants were classified into 4 groups based on the IT value; Low: 60 implants (10-29 Ncm, mean=15 Ncm); Regular: 102 implants (30-50 Ncm, mean=42 Ncm); High: 47 implants (51-100 Ncm, mean=75 Ncm); and Very high: 21 implants (101-200 Ncm, mean=170 Ncm).
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All patients received a single Tapered Screw implant (Bioinnovation Dental®, Brazil).
The implants were placed according to the manufacturer's instructions by using the appropriate burs with a final master drill of 3.5 or 4.5 mm in diameter by one senior oral surgeon.
These implants were multi-threaded, and their surfaces were both sandblasted and acid etched.
Of the 230 participants, 172 received a single 5 x 10-mm implant, and 58 received a 4 x 10-mm implant.
Other Names:
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Experimental: Post-operative Pain
After implant placement, all participants were requested to record their pain level using the 10-cm visual analog scale (VAS) ranging from 0 "no pain" to 10 "worst pain ever."
The scale had no other markings along the line.
Patients were asked to record their pain level after surgery, 24 hours after surgery, at day 2, day 4 and at week 1, week 2, and week 3.
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All patients received a single Tapered Screw implant (Bioinnovation Dental®, Brazil).
The implants were placed according to the manufacturer's instructions by using the appropriate burs with a final master drill of 3.5 or 4.5 mm in diameter by one senior oral surgeon.
These implants were multi-threaded, and their surfaces were both sandblasted and acid etched.
Of the 230 participants, 172 received a single 5 x 10-mm implant, and 58 received a 4 x 10-mm implant.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative pain
Time Frame: 1 month
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Pain was assessed after surgery using the 10-cm visual analog scale (VAS) ranging from 0 "no pain" to 10 "worst pain ever."
The scale has no other markings along the line.
Patients will be asked to record their pain level before surgery and after surgery, 24 hours after surgery, at day 2, day 4 and at week 1, week 2, and week 3.
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1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival rate of implants
Time Frame: 36 months
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Implant survival was assessed clinically and radiographically at 3, 6, 12, 24 and 36 months.
The criteria for implant success according to Buser et al, were no radiolucent zone around the implant, confirmed individual implant stability, and no suppuration, pain or ongoing pathologic processes (Buser et al., 1997).
All implants that failed to fulfill these criteria were regarded as failures.
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36 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ahmed Aziz, PhD, University of Sharjah
Publications and helpful links
General Publications
- Alissa R, Sakka S, Oliver R, Horner K, Esposito M, Worthington HV, Coulthard P. Influence of ibuprofen on bone healing around dental implants: a randomised double-blind placebo-controlled clinical study. Eur J Oral Implantol. 2009 Autumn;2(3):185-99.
- Al-Khabbaz AK, Griffin TJ, Al-Shammari KF. Assessment of pain associated with the surgical placement of dental implants. J Periodontol. 2007 Feb;78(2):239-46. doi: 10.1902/jop.2007.060032.
- Augustin G, Davila S, Udilljak T, Staroveski T, Brezak D, Babic S. Temperature changes during cortical bone drilling with a newly designed step drill and an internally cooled drill. Int Orthop. 2012 Jul;36(7):1449-56. doi: 10.1007/s00264-012-1491-z.
- Barewal RM, Oates TW, Meredith N, Cochran DL. Resonance frequency measurement of implant stability in vivo on implants with a sandblasted and acid-etched surface. Int J Oral Maxillofac Implants. 2003 Sep-Oct;18(5):641-51.
- 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.
- Beaudette JR, Fritz PC, Sullivan PJ, Piccini A, Ward WE. Investigation of factors that influence pain experienced and the use of pain medication following periodontal surgery. J Clin Periodontol. 2018 May;45(5):578-585. doi: 10.1111/jcpe.12885. Epub 2018 Apr 16.
- Becker W, Becker BE, Hujoel P, Abu Ras Z, Goldstein M, Smidt A. Prospective clinical trial evaluating a new implant system for implant survival, implant stability and radiographic bone changes. Clin Implant Dent Relat Res. 2013 Feb;15(1):15-21. doi: 10.1111/j.1708-8208.2010.00333.x. Epub 2011 Jan 11.
- 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.
- Bryce G, Bomfim DI, Bassi GS. Pre- and post-operative management of dental implant placement. Part 1: management of post-operative pain. Br Dent J. 2014 Aug;217(3):123-7. doi: 10.1038/sj.bdj.2014.650.
- Calandriello R, Tomatis M, Rangert B. Immediate functional loading of Branemark System implants with enhanced initial stability: a prospective 1- to 2-year clinical and radiographic study. Clin Implant Dent Relat Res. 2003;5 Suppl 1:10-20. doi: 10.1111/j.1708-8208.2003.tb00011.x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 210
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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