Implant ComplicationNCT04877145
Implant Placement Using a Newly Designed Single Drill Versus Conventional Sequential Drills
A study testing drill in people with Implant Complication, run by Assiut University at 1 site in Egypt.
Trial summary
dental implants are usually placed by sequential set of drills which could increase the time of the surgery and could raise the temperature of the osteotomy preparation so a new drill was designed to place the implants fast and easy way Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Complication
- What is being tested?
- drill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Feb 2017to 20 Apr 2021
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The inclusion criteria :
- implant recipient sites free from any pathological conditions.
- Patients who were cooperative, motivated and hygiene conscious were selected.
- non smoker patients
Who cannot join
- Patients unable to undergo minor oral surgical procedures
- patients with a history of drug abuse or catabolic drugs were not included.
- Patients with a history of psychiatric disorder and those with unrealistic expectations about the aesthetic outcome of implant therapy were also excluded.
- Patients with insufficient vertical inter-arch space, on centric occlusion, to accommodate the available restorative components .
- Uncontrolled diabetic patients
- Patient who had any systemic condition that may contraindicate implant therapy (impaired wound healing - bleeding disorders
- patients who had any habits that might jeopardise the osseointegration process, such as heavy smoking and alcoholism.
- Patients with para-functional habits that produce overload on the implant, such as bruxism and clenching were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Drill Vrs Sequential Drill Dental Implants Placement
dental implants are usually placed by sequential set of drills which could increase the time of the surgery and could raise the temperature of the osteotomy preparation so a new drill was designed to place the implants fast and easy way
Read the detailed description
Dental implant success is evident nowadays with the predictable functional and aesthetic results obtained . Simplified techniques and approaches are preferred for the convenience of both the patients and operators . Current research is focusing on decreasing the number of instruments used, shortening of the operation time and performing flapless approaches for implant placement whenever possible. This is done to reduce the postoperative complaints, such as pain, swelling and bleeding; thus decreasing the need for analgesics and minimising the occurrence of morbidity .
- Conditions
- Implant Complication
- Being tested
- drill
- Keywords
- implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drillOther
single 3.25 mm stainless steel drill
| Study group | Role | What they receive |
|---|---|---|
| single drill | Experimental | one drill to place the implants 3.25mm diameter stainless steel drill was used. Receives: Other: drill |
| sequential drills | Active comparator | For the control group, four drills (2.2mm, 2.75mm, 3.25mm and 4mm diameter), Receives: Other: drill |
What is being measured
The primary outcome is the main question the study is designed to answer.
osseointegration of the dental implants
healing and union of the dental implants with the surrounding bone measured by torque wrench exceeds 30 N/CM
Measured: 6 months
Secondary outcomes (2)
mobility
the fixation of the implants checked by perio test M (-8- 0) INDICATES nonmobile
Measured: 6 months
bone loss
by periapical xray the bone loss measured from the platform of the implant if present unit of measurement : mm
Measured: 6 months , 1 ,2 and 3 years after function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start12 Feb 2017
- Primary completion8 Feb 2021
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Implant ComplicationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mortada, Cairo University
- Investigators
- amr ah zahran, phd, Study director, professor of periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877145
- Sponsor's protocol ID
- 17300587
- Status last verified
- May 2021
- First submitted
- 1 May 2021
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: after using the single drill compared with the sequential drill all the implants checked for osseointegration , mobility and bone loss after function
Publications
La Du BN. The human serum paraoxonase/arylesterase polymorphism. Am J Hum Genet. 1988 Sep;43(3):227-9. No abstract available.
PubMed 2843045Bacci C, Lucchiari N, Frigo AC, Stecco C, Zanette G, Dotto V, Sivolella S. Temperatures generated during implant site preparation with conventional drilling versus single-drill method: an ex-vivo human mandible study. Minerva Stomatol. 2019 Dec;68(6):277-284. doi: 10.23736/S0026-4970.19.04142-6.
PubMed 32052615Abboud M, Delgado-Ruiz RA, Kucine A, Rugova S, Balanta J, Calvo-Guirado JL. Multistepped Drill Design for Single-Stage Implant Site Preparation: Experimental Study in Type 2 Bone. Clin Implant Dent Relat Res. 2015 Oct;17 Suppl 2:e472-85. doi: 10.1111/cid.12273. Epub 2014 Sep 29.
PubMed 25263993Lucchiari N, Frigo AC, Stellini E, Coppe M, Berengo M, Bacci C. In Vitro Assessment with the Infrared Thermometer of Temperature Differences Generated During Implant Site Preparation: The Traditional Technique Versus the Single-Drill Technique. Clin Implant Dent Relat Res. 2016 Feb;18(1):182-91. doi: 10.1111/cid.12246. Epub 2014 Jul 17.
PubMed 25040939
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Drill Vrs Sequential Drill Dental Implants Placement
- ClinicalTrials.gov ID
- NCT04877145
- Acronym / sponsor ID
- 17300587
- Conditions
- Implant Complication
- Keywords
- implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 12 Feb 2017 (actual)
- Primary completion
- 8 Feb 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 7 May 2021 (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.
dental implants are usually placed by sequential set of drills which could increase the time of the surgery and could raise the temperature of the osteotomy preparation so a new drill was designed to place the implants fast and easy way
Detailed description
Dental implant success is evident nowadays with the predictable functional and aesthetic results obtained . Simplified techniques and approaches are preferred for the convenience of both the patients and operators . Current research is focusing on decreasing the number of instruments used, shortening of the operation time and performing flapless approaches for implant placement whenever possible. This is done to reduce the postoperative complaints, such as pain, swelling and bleeding; thus decreasing the need for analgesics and minimising the occurrence of morbidity .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single drill | Experimental | Other: drillone drill to place the implants 3.25mm diameter stainless steel drill was used. |
| sequential drills | Active comparator | Other: drillFor the control group, four drills (2.2mm, 2.75mm, 3.25mm and 4mm diameter), |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The inclusion criteria :
Key exclusion criteria (8 listed)
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 |
|---|---|---|
| drillsingle 3.25 mm stainless steel drill | Other | sequential drills, single drill |
Primary outcome
osseointegration of the dental implants
Time frame: 6 months
healing and union of the dental implants with the surrounding bone measured by torque wrench exceeds 30 N/CM
2 secondary outcomes
mobility
Time frame: 6 months
bone loss
Time frame: 6 months , 1 ,2 and 3 years after function
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 7 May 2021.
- Background: PubMed 2843045La Du BN. The human serum paraoxonase/arylesterase polymorphism. Am J Hum Genet. 1988 Sep;43(3):227-9. No abstract available.
- Background: PubMed 32052615Bacci C, Lucchiari N, Frigo AC, Stecco C, Zanette G, Dotto V, Sivolella S. Temperatures generated during implant site preparation with conventional drilling versus single-drill method: an ex-vivo human mandible study. Minerva Stomatol. 2019 Dec;68(6):277-284. doi: 10.23736/S0026-4970.19.04142-6.
- Background: PubMed 25263993Abboud M, Delgado-Ruiz RA, Kucine A, Rugova S, Balanta J, Calvo-Guirado JL. Multistepped Drill Design for Single-Stage Implant Site Preparation: Experimental Study in Type 2 Bone. Clin Implant Dent Relat Res. 2015 Oct;17 Suppl 2:e472-85. doi: 10.1111/cid.12273. Epub 2014 Sep 29.
- Background: PubMed 25040939Lucchiari N, Frigo AC, Stellini E, Coppe M, Berengo M, Bacci C. In Vitro Assessment with the Infrared Thermometer of Temperature Differences Generated During Implant Site Preparation: The Traditional Technique Versus the Single-Drill Technique. Clin Implant Dent Relat Res. 2016 Feb;18(1):182-91. doi: 10.1111/cid.12246. Epub 2014 Jul 17.
- Individual participant dataSharing planned: No. after using the single drill compared with the sequential drill all the implants checked for osseointegration , mobility and bone loss after function
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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.
amr ah zahran, phd study director
professor of periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing drill in people with Implant Complication, run by Assiut University at 1 site in Egypt.
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 4 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 7 May 2021. 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 Egypt. 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?
osseointegration of the dental implants (time frame: 6 months). 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 NCT04877145, which also lists 4 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 7 May 2021.