Influence of Insertion Torque and Bone Type on Post-operative Pain

NCT06412380 | Completed

• 1 other identifier: 210
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this clinical study were to assess the effect of different ITs and bone types on POP levels and survival rates and to investigate the effect of different patient- and site-related factors on POP levels and survival rates.

Conditions

Postoperative Pain; Postsurgical Pain; Dental Implant Failed

Outcome Measures

Primary Outcomes (1)

• Post-operative pain

  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.

  1 month

Secondary Outcomes (1)

• Survival rate of implants

  36 months

Study Arms (2)

Pain level

EXPERIMENTAL

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.

Procedure: Implant insertion

Implant torque

EXPERIMENTAL

Implants were classified into 4 groups based on the IT value; Low: 58 implants (10-29 Ncm); Regular: 95 implants (30-50 Ncm); High: 46 implants (51-100 Ncm); and Very High: 31 implants (101-180 Ncm).

Procedure: Implant insertion

Interventions

Implant insertion PROCEDURE

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.

Also known as: Implant surgery

Implant torque; Pain level

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 - 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sharjah: lead
• Yarmouk University: collaborator

Study Sites (1)

University of Sharjah

Sharjah city, 7724, United Arab Emirates

Location

Related Publications (10)

• 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.

  PMID: 17274712 BACKGROUND

• 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.

  PMID: 20467629 BACKGROUND

• 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.

  PMID: 22290154 BACKGROUND

• 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.

  PMID: 14579951 BACKGROUND

• 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: 26043651 BACKGROUND

• 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.

  PMID: 29500837 BACKGROUND

• 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.

  PMID: 21223489 BACKGROUND

• 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: 27129002 BACKGROUND

• 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.

  PMID: 25104691 BACKGROUND

• 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.

  PMID: 12691646 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ahmed Aziz, PhD

  University of Sharjah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 14, 2024
• Study Start: December 1, 2019
• Primary Completion: December 20, 2023
• Study Completion: February 15, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)