Dental AnxietyNCT03871101
Evaluation of Dental Anxiety in Second-Stage Implant Surgery With Er,Cr:YSGG Laser
A study testing Scalpel and 2780 nm Er,Cr:YSGG Laser in people with Dental Anxiety, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
Implants embedded under the oral mucosa were exposed with scalpel (Group 1) or laser surgery (Group 2). Before the operation the patients were asked to fill the State-Trait Anxiety Inventory (STAI) and Dental Anxiety Scale (DAS) while resting in the waiting room. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Scalpel and 2780 nm Er,Cr:YSGG Laser
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jan 2018to 17 Sep 2018
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients undergoing second-stage implant surgery
Who cannot join
- Patients without sufficient keratinized gingiva
- Bone overlap on closure screw
- Implants that can not be localized due to gingiva thickness,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yuzuncu Yil University Faculty of Dentistry
Van, 65080
About this study
Official title: Evaluation of Dental Anxiety in Patients Undergoing Second Stage Surgery With Er,Cr:YSGG Laser Treatment: Randomized Clinical Trial
Implants embedded under the oral mucosa were exposed with scalpel (Group 1) or laser surgery (Group 2). Before the operation the patients were asked to fill the State-Trait Anxiety Inventory (STAI) and Dental Anxiety Scale (DAS) while resting in the waiting room.
- Conditions
- Dental Anxiety
- Being tested
- Scalpel, 2780 nm Er,Cr:YSGG Laser
- Keywords
- Dental Anxiety, STAI, Er,Cr:YSGG, oral surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScalpelProcedure or surgery
Exposure of the cover screw of osseointegrated dental implants embedded under oral mucosa by performing the soft tissue incision with scalpel for placing the healing abutment.
2780 nm Er,Cr:YSGG LaserDevice
Exposure of the cover screw of osseointegrated dental implants embedded under oral mucosa by performing the soft tissue incision with erbium laser for placing the healing abutment.
| Study group | Role | What they receive |
|---|---|---|
| Scalpel | Active comparator | Soft tissue incision with scalpel in second- stage implant surgery. Receives: Procedure: Scalpel |
| Erbium laser | Experimental | Soft tissue incision with 2780 nm Er,Cr:YSGG laser, at implant recovery settings (2.00 W power, 100 Hz H mode, 10% water and 10% air) in second-stage implant surgery. Receives: Device: 2780 nm Er,Cr:YSGG Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental anxiety
Before the operation the patients were asked to fill the State-Trait Anxiety Inventory (STAI) questionary.Patients' answers to each question were scored between 1-4 points. A total of 20-37 anxiety scores were assessed as minimum level of anxiety or none, 38-44 points as moderate and 45-80 as high.
Measured: 20 minutes before the operation
Dental Anxiety
Before the operation the patients were asked to fill the Dental Anxiety Scale (DAS). Patients' answers to questions were scored between 1-4 points. The total score of the questions in the questionnaire ranged from 4 to 20, and 4-11 points were interpreted as low level dental anxiety, 12-14 points as moderate and more than 14 points as high.
Measured: 20 minutes before the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start8 Jan 2018
- Primary completion10 Jul 2018
- Study completion17 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erkan Feslihan, Yuzuncu Yil University
- Investigators
- Ahmet C Talmac, Study chair, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871101
- Sponsor's protocol ID
- 24112017-02
- Status last verified
- Mar 2019
- First submitted
- 9 Mar 2019
- Last updated
- 14 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Candido MC, Andreatini R, Zielak JC, de Souza JF, Losso EM. Assessment of anxiety in patients who undergo surgical procedures for tooth implants: a prospective study. Oral Maxillofac Surg. 2015 Sep;19(3):253-8. doi: 10.1007/s10006-014-0480-3. Epub 2015 Jan 10.
PubMed 25572978Kazancioglu HO, Dahhan AS, Acar AH. How could multimedia information about dental implant surgery effects patients' anxiety level? Med Oral Patol Oral Cir Bucal. 2017 Jan 1;22(1):e102-e107. doi: 10.4317/medoral.21254.
PubMed 27918733
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dental Anxiety in Patients Undergoing Second Stage Surgery With Er,Cr:YSGG Laser Treatment: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03871101
- Acronym / sponsor ID
- 24112017-02
- Conditions
- Dental Anxiety
- Keywords
- Dental Anxiety, STAI, Er,Cr:YSGG, oral surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 17 Sep 2018 (actual)
- First posted
- 12 Mar 2019 (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.
Implants embedded under the oral mucosa were exposed with scalpel (Group 1) or laser surgery (Group 2). Before the operation the patients were asked to fill the State-Trait Anxiety Inventory (STAI) and Dental Anxiety Scale (DAS) while resting in the waiting room.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scalpel | Active comparator | Procedure: ScalpelSoft tissue incision with scalpel in second- stage implant surgery. |
| Erbium laser | Experimental | Device: 2780 nm Er,Cr:YSGG LaserSoft tissue incision with 2780 nm Er,Cr:YSGG laser, at implant recovery settings (2.00 W power, 100 Hz H mode, 10% water and 10% air) in second-stage implant surgery. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing second-stage implant surgery
Key exclusion criteria (3 listed)
- Patients without sufficient keratinized gingiva
- Bone overlap on closure screw
- Implants that can not be localized due to gingiva thickness,
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 |
|---|---|---|
| ScalpelExposure of the cover screw of osseointegrated dental implants embedded under oral mucosa by performing the soft tissue incision with scalpel for placing the healing abutment. | Procedure or surgery | Scalpel |
| 2780 nm Er,Cr:YSGG LaserExposure of the cover screw of osseointegrated dental implants embedded under oral mucosa by performing the soft tissue incision with erbium laser for placing the healing abutment. | Device | Erbium laser |
Primary outcome
Dental anxiety
Time frame: 20 minutes before the operation
Before the operation the patients were asked to fill the State-Trait Anxiety Inventory (STAI) questionary.Patients' answers to each question were scored between 1-4 points. A total of 20-37 anxiety scores were assessed as minimum level of anxiety or none, 38-44 points as moderate and 45-80 as high.
Dental Anxiety
Time frame: 20 minutes before the operation
Before the operation the patients were asked to fill the Dental Anxiety Scale (DAS). Patients' answers to questions were scored between 1-4 points. The total score of the questions in the questionnaire ranged from 4 to 20, and 4-11 points were interpreted as low level dental anxiety, 12-14 points as moderate and more than 14 points as high.
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 14 Mar 2019.
- Background: PubMed 25572978Candido MC, Andreatini R, Zielak JC, de Souza JF, Losso EM. Assessment of anxiety in patients who undergo surgical procedures for tooth implants: a prospective study. Oral Maxillofac Surg. 2015 Sep;19(3):253-8. doi: 10.1007/s10006-014-0480-3. Epub 2015 Jan 10.
- Background: PubMed 27918733Kazancioglu HO, Dahhan AS, Acar AH. How could multimedia information about dental implant surgery effects patients' anxiety level? Med Oral Patol Oral Cir Bucal. 2017 Jan 1;22(1):e102-e107. doi: 10.4317/medoral.21254.
- Individual participant dataSharing planned: No
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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.
Ahmet C Talmac study chair
Yuzuncu Yil University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scalpel and 2780 nm Er,Cr:YSGG Laser in people with Dental Anxiety, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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 1 inclusion and 3 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 14 Mar 2019. 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 Turkey (Türkiye). 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?
Dental anxiety (time frame: 20 minutes before the operation). The study lists 2 primary outcomes in all. 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 NCT03871101, which also lists 2 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 14 Mar 2019.