Tooth Extraction Status NosNCT03485664
Acutely Infected Teeth: To Extract Or Not To Extract?
An observational study of Tooth Extraction Status Nos, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
This prospective study was performed on 82 participants. Severe pain on percussion of the relevant tooth was considered as basic criteria when deciding on acute infection phase. The acutely infected teeth were labeled as the study group (n=35) and the asymptomatic ones as the control group (n=47). Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Tooth Extraction Status Nos
- What is being tested?
- tooth extraction
- Type of treatment
- Surgery or procedure
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2017to 15 Mar 2018
- Phase
- Observational
- 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 79 years
- All sexes
- Adult, Older adult
Study population: The patients were selected among medically healthy volunteers, who referred to the investigators for extraction only one mandibular molar tooth. The informed consents were obtained. Exclusion criteria were smoking, oral contraceptive use, any conditions affecting the immune system, usage of antibiotics in last two weeks and the teeth needed surgical extractions. percussion sensitivity is used as separator between two groups.
Who may be able to join
- indication for only one mandibular molar tooth extraction (severe pain on percussion labeled as the study group and asymptomatic ones labeled as the control group)
Who cannot join
- smoking, oral contraceptive use, any conditions affecting the immune system, usage of antibiotics in last two weeks the teeth needed surgical extraction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University, Faculty of dentistry
Konya
About this study
This prospective study was performed on 82 participants. Severe pain on percussion of the relevant tooth was considered as basic criteria when deciding on acute infection phase. The acutely infected teeth were labeled as the study group (n=35) and the asymptomatic ones as the control group (n=47). The extractions were done in the usual way. Amount of anesthetic solution used and durations of extractions were recorded.
Read the detailed description
This research designed as a prospective study between February 2017 and June 2017. An ethical committee approval was obtained (document number 2017/01). The patients were selected among medically healthy volunteers, who referred to us for extraction only one mandibular molar tooth. The informed consents were obtained. Exclusion criteria were smoking, oral contraceptive use, any conditions affecting the immune system, usage of antibiotics in last two weeks and the teeth needed surgical extractions.
A total of 82 patients aged between 15 and 79 years (mean 40.52 ± 15.46) met the study criteria. When deciding on acute infection phase, percussion sensitivity was accepted as the basic criteria. It was defined as severe pain when a dental mirror was dropped about 1 cm above the tooth.
Patients with acutely infected teeth were labeled as "study group" (n = 35) and the asymptomatic patients as "control group" (n = 47). The null hypothesis of the study was "there is no significant difference between the acutely infected and asymptomatic lower molar teeth in terms of the complications that may occur during and after tooth extraction". The level of statistical significance was accepted as 0.05 and SigmaPlot 11.0 (Systat Software, Inc., San Jose, Calif.) program was used for statistical analyses.
Surgical Method All the extractions were performed by the same operator. The investigators used 4% Articaine and 1:100,000 epinephrine HCL as the anesthetic solution. Inferior alveolar nerve (IAN) and buccal nerve (BN) blockages were performed by using 1.5 mL. and 0.5 mL of solution, respectively. If the anesthesia had failed, the same procedure was repeated. The amount of anesthetic solution used for each patient was recorded.
Numbness on the half of the lower lip, and feeling no pain when probing the periodontal space of the target tooth was accepted a successful IAN blockage. Then the BN blockage was performed and the routine extraction was completed. Unless there was a radiographically confirmed granulation tissue, the investigators did not curette the extraction sockets. The investigators also did not package any medications into the wounds or did not suture. A sterile damp gauze was placed tightly on the extraction area and the patients were asked to bite it for 20 minutes. Extraction durations were noted for each patient.
All patients were given postoperative instructions. In the presence of a possible complication, they were asked to apply to our clinic and not to use antibiotics on their own.
Postoperative Evaluation of Systemic Condition The investigators called all the patients on first and second post-extraction days for assessing the systemic signs of fever, fatigue, and shivering.
Postoperative Evaluation of The Extraction Wound If the patients applied with severe pain, The investigators recorded onset time and characteristic of the pain. In the intraoral examination, no granulation tissue as a sign of healing and exposed bare alveolar bone was accepted as alveolar osteitis.
The investigators use SigmaPlot 11.0 (Systat Software, Inc., San Jose, CA) package software programme for statistical analysis. To compare the rates of AO, chi-square test with Yates correction was employed. Shapiro-Wilk normality test was performed on the data for the amount of anesthetic solution used and the duration of extractions. Since the data did not fit the normal distribution, nonparametric Mann Whitney U test was used.
- Conditions
- Tooth Extraction Status Nos
- Being tested
- tooth extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tooth extractionProcedure or surgery
tooth extraction
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Severe pain on percussion of the relevant tooth was considered as basic criteria when deciding on acute infection phase. The acutely infected teeth were labelled as the study group Receives: Procedure: tooth extraction | |
| Control Group | The asymptomatic teeth were labelled as the control group Receives: Procedure: tooth extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis of alveolaris osteitis
Measured: 1-4 days
diagnosis of systemic response
Measured: 1-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start15 Feb 2017
- Primary completion15 Jan 2018
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Extraction Status NosStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökhan Gürses, Necmettin Erbakan University
- Investigators
- Dilek Menziletoğlu, Study director, Academic MemberBozkurt Kubilay Işık, Study chair, ConcultantGökhan Gürses, Principal investigator, Care Provider
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485664
- Sponsor's protocol ID
- NecmettinEU-Dentistry-2
- Status last verified
- Mar 2018
- First submitted
- 23 Mar 2018
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A total of 82 patients aged between 15 and 79 years (mean 40.52 ± 15.46) met the study criteria. When deciding on acute infection phase, percussion sensitivity was accepted as the basic criteria. It was defined as severe pain when a dental mirror was dropped about 1 cm above the tooth. Patients with acutely infected teeth were labelled as "study group" (n = 35) and the asymptomatic patients as "control group" (n = 47). Null hypothesis of the study was "there is no significant difference between the acutely infected and asymptomatic lower molar teeth in terms of the complications that may occur during and after tooth extraction". The level of statistical significance was accepted as 0.05 and SigmaPlot 11.0 program was used for statistical analyses.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acutely Infected Teeth: To Extract Or Not To Extract?
- ClinicalTrials.gov ID
- NCT03485664
- Acronym / sponsor ID
- NecmettinEU-Dentistry-2
- Conditions
- Tooth Extraction Status Nos
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 2 Apr 2018 (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.
This prospective study was performed on 82 participants. Severe pain on percussion of the relevant tooth was considered as basic criteria when deciding on acute infection phase. The acutely infected teeth were labeled as the study group (n=35) and the asymptomatic ones as the control group (n=47). The extractions were done in the usual way. Amount of anesthetic solution used and durations of extractions were recorded.
Detailed description
This research designed as a prospective study between February 2017 and June 2017. An ethical committee approval was obtained (document number 2017/01). The patients were selected among medically healthy volunteers, who referred to us for extraction only one mandibular molar tooth. The informed consents were obtained. Exclusion criteria were smoking, oral contraceptive use, any conditions affecting the immune system, usage of antibiotics in last two weeks and the teeth needed surgical extractions.
A total of 82 patients aged between 15 and 79 years (mean 40.52 ± 15.46) met the study criteria. When deciding on acute infection phase, percussion sensitivity was accepted as the basic criteria. It was defined as severe pain when a dental mirror was dropped about 1 cm above the tooth.
Patients with acutely infected teeth were labeled as "study group" (n = 35) and the asymptomatic patients as "control group" (n = 47). The null hypothesis of the study was "there is no significant difference between the acutely infected and asymptomatic lower molar teeth in terms of the complications that may occur during and after tooth extraction". The level of statistical significance was accepted as 0.05 and SigmaPlot 11.0 (Systat Software, Inc., San Jose, Calif.) program was used for statistical analyses.
Surgical Method All the extractions were performed by the same operator. The investigators used 4% Articaine and 1:100,000 epinephrine HCL as the anesthetic solution. Inferior alveolar nerve (IAN) and buccal nerve (BN) blockages were performed by using 1.5 mL. and 0.5 mL of solution, respectively. If the anesthesia had failed, the same procedure was repeated. The amount of anesthetic solution used for each patient was recorded.
Numbness on the half of the lower lip, and feeling no pain when probing the periodontal space of the target tooth was accepted a successful IAN blockage. Then the BN blockage was performed and the routine extraction was completed. Unless there was a radiographically confirmed granulation tissue, the investigators did not curette the extraction sockets. The investigators also did not package any medications into the wounds or did not suture. A sterile damp gauze was placed tightly on the extraction area and the patients were asked to bite it for 20 minutes. Extraction durations were noted for each patient.
All patients were given postoperative instructions. In the presence of a possible complication, they were asked to apply to our clinic and not to use antibiotics on their own.
Postoperative Evaluation of Systemic Condition The investigators called all the patients on first and second post-extraction days for assessing the systemic signs of fever, fatigue, and shivering.
Postoperative Evaluation of The Extraction Wound If the patients applied with severe pain, The investigators recorded onset time and characteristic of the pain. In the intraoral examination, no granulation tissue as a sign of healing and exposed bare alveolar bone was accepted as alveolar osteitis.
The investigators use SigmaPlot 11.0 (Systat Software, Inc., San Jose, CA) package software programme for statistical analysis. To compare the rates of AO, chi-square test with Yates correction was employed. Shapiro-Wilk normality test was performed on the data for the amount of anesthetic solution used and the duration of extractions. Since the data did not fit the normal distribution, nonparametric Mann Whitney U test was used.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Procedure: tooth extractionSevere pain on percussion of the relevant tooth was considered as basic criteria when deciding on acute infection phase. The acutely infected teeth were labelled as the study group |
| Control Group | – | Procedure: tooth extractionThe asymptomatic teeth were labelled as the control group |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The patients were selected among medically healthy volunteers, who referred to the investigators for extraction only one mandibular molar tooth. The informed consents were obtained. Exclusion criteria were smoking, oral contraceptive use, any conditions affecting the immune system, usage of antibiotics in last two weeks and the teeth needed surgical extractions. percussion sensitivity is used as separator between two groups.
Key inclusion criteria (1 listed)
- indication for only one mandibular molar tooth extraction (severe pain on percussion labeled as the study group and asymptomatic ones labeled as the control group)
Key exclusion criteria (1 listed)
- smoking, oral contraceptive use, any conditions affecting the immune system, usage of antibiotics in last two weeks the teeth needed surgical extraction
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 |
|---|---|---|
| tooth extractiontooth extraction | Procedure or surgery | Control Group, Study Group |
Primary outcome
diagnosis of alveolaris osteitis
Time frame: 1-4 days
diagnosis of systemic response
Time frame: 1-7 days
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 3 Apr 2018.
- Individual participant dataSharing planned: No. A total of 82 patients aged between 15 and 79 years (mean 40.52 ± 15.46) met the study criteria. When deciding on acute infection phase, percussion sensitivity was accepted as the basic criteria. It was defined as severe pain when a dental mirror was dropped about 1 cm above the tooth. Patients with acutely infected teeth were labelled as "study group" (n = 35) and the asymptomatic patients as "control group" (n = 47). Null hypothesis of the study was "there is no significant difference between the acutely infected and asymptomatic lower molar teeth in terms of the complications that may occur during and after tooth extraction". The level of statistical significance was accepted as 0.05 and SigmaPlot 11.0 program was used for statistical analyses.
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Recruiting
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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.
Dilek Menziletoğlu study director
Academic Member
Bozkurt Kubilay Işık study chair
Concultant
Gökhan Gürses principal investigator
Care Provider
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Extraction Status Nos, run by Necmettin Erbakan 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 1 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 3 Apr 2018. 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?
diagnosis of alveolaris osteitis (time frame: 1-4 days). 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?
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 3 Apr 2018.