Postoperative PainNCT06412380
Influence of Insertion Torque and Bone Type on Post-operative Pain
A study testing Implant insertion in people with Postoperative Pain and Postsurgical Pain, run by University of Sharjah at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Postsurgical Pain, Dental Implant Failed
- What is being tested?
- Implant insertion
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Dec 2019to 15 Feb 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
University of Sharjah
Sharjah city, 7724
About this study
Official title: Influence of High Insertion Torque and Type of Bone on Post-operative Pain and Survival Rate of Dental Implants
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.
Read the 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.
- Conditions
- Postoperative Pain, Postsurgical Pain, Dental Implant Failed
- Being tested
- Implant insertion
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant insertionProcedure or surgery
Also called Implant surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Procedure: Implant insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (1)
Survival rate of implants
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start1 Dec 2019
- Primary completion20 Dec 2023
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Collaborators
- Yarmouk University
- Responsible party
- Principal investigator, Ahmed Aziz, University of Sharjah
- Investigators
- Ahmed Aziz, PhD, Principal investigator, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412380
- Sponsor's protocol ID
- 210
- Status last verified
- Jul 2024
- First submitted
- 8 May 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individuals data will not be shared, data required normally for publication will be shared upon reasonable request.
Publications
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.
PubMed 17274712Alissa 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.
PubMed 20467629Augustin 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.
PubMed 22290154Barewal 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.
PubMed 14579951Barone 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 26043651Beaudette 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.
PubMed 29500837Becker 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.
PubMed 21223489Berardini 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 27129002Bryce 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.
PubMed 25104691Calandriello 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.
PubMed 12691646
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of High Insertion Torque and Type of Bone on Post-operative Pain and Survival Rate of Dental Implants
- ClinicalTrials.gov ID
- NCT06412380
- Acronym / sponsor ID
- 210
- Conditions
- Postoperative Pain, Postsurgical Pain, Dental Implant Failed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Collaborators
- Yarmouk University
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain level | Experimental | Procedure: Implant insertionAfter 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. |
| Implant torque | Experimental | Procedure: Implant insertionImplants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- uncontrolled diabetes
- hypertension
- pregnancy
- bone diseases
- use of bisphosphonates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implant insertionAlso: Implant surgeryAll 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. | Procedure or surgery | Implant torque, Pain level |
Primary outcome
Post-operative pain
Time frame: 1 month
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 secondary outcome
Survival rate of implants
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Background: PubMed 17274712Al-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.
- Background: PubMed 20467629Alissa 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.
- Background: PubMed 22290154Augustin 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.
- Background: PubMed 14579951Barewal 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.
- Background: PubMed 26043651Barone 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.
- Background: PubMed 29500837Beaudette 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.
- Background: PubMed 21223489Becker 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.
- Background: PubMed 27129002Berardini 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.
- Background: PubMed 25104691Bryce 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.
- Background: PubMed 12691646Calandriello 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.
- Individual participant dataSharing planned: No. Individuals data will not be shared, data required normally for publication will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Aziz, PhD principal investigator
University of Sharjah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant insertion in people with Postoperative Pain and Postsurgical Pain, run by University of Sharjah at 1 site in United Arab Emirates.
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 3 inclusion and 8 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 25 Jul 2024. 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 United Arab Emirates. 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?
Post-operative pain (time frame: 1 month). 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 NCT06412380, which also lists 10 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 25 Jul 2024.