Pain and Discomfort During Scaling and Root Planning of Patients WithPhase 2NCT01878864
Effect of Local Anesthesia in Patients With Marginal Periodontitis Undergoing Scaling and Root Planning
A Phase 2 study testing Bupivacaine lozenge and Lidocaine-adrenalin injection in people with Pain and Discomfort During Scaling and Root Planning of Patients With and Periodontitis, run by Ove Andersen at 3 sites in Denmark.
Trial summary
A randomised cross-over study comparing two methods of local anaesthesia for patients diagnosed with periodontitis undergoing scaling and root planning. 40 patients will be included in the study, which aims to demonstrate that the effect of a bupivacaine lozenge is non-inferior to lidocaine-adrenalin injections. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain and Discomfort During Scaling and Root Planning of Patients With, Periodontitis
- What is being tested?
- Bupivacaine lozenge and Lidocaine-adrenalin injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesDenmark
- Study dates
- Nov 2012to Jun 2013
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed as having, respectively periodontitis marginalis adulta progressiva lenta and periodontitis marginalis adulta progressiva rapid in the hygiene phase, where depurations are repeated within a short timeframe
- Age between 18 and 80 years
- Ability to speak, read and understand danish
- Ability to give oral and written consent
Who cannot join
- Known allergy to bupivacaine or other local anaesthetics of the amide type
- Other gingival infections (eg lichen planus)
- Pregnancy -if in doubt a pregnancy test will be made
- Breastfeeding
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Tandlægerne Vimmelskaftet
Copenhagen K, 1161
Frederiksberg Tandlægerne
Frederiksberg, 2000
Tandlægepraksis ved Jonna Bork
Hvidovre, 2650
About this study
A randomised cross-over study comparing two methods of local anaesthesia for patients diagnosed with periodontitis undergoing scaling and root planning. 40 patients will be included in the study, which aims to demonstrate that the effect of a bupivacaine lozenge is non-inferior to lidocaine-adrenalin injections.
Read the detailed description
40 periodontitis patients undergoing scaling and root planning (SRP) will be randomised to receive local anaesthesia by either a bupivacaine lozenge or lidocaine-adrenalin injection at their first visit. At the following visit, the patients will receive the opposite treatment.
At each visit the patient will evaluate pain before, during and after SRP by:
- Visual Analog Scale (VAS) 0-10 where 0 = no pain, 10 = extreme pain.
- McGills Pain Questionnaire (MPQ), which gives a qualitative pain profile.
At each visit the patient will evaluate discomfort before, during and after the SRP by:
- Visual Analog Scale (VAS) 0-10 where 0 = no discomfort, 10 = extreme discomfort.
Additionally the patient assesses the comfort of administration of the two local anaesthesia as well as the taste of the bupivacaine lozenge. The investigator also evaluates the scaling procedure.
- Being tested
- Bupivacaine lozenge, Lidocaine-adrenalin injection
- Keywords
- Pain, Discomfort, Periodontitis, Scaling and Root Planning, Visual Analogue Scale, McGills Pain Questionnaire
- Medical subject headings
- Pain, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine lozengeDrug
Lidocaine-adrenalin injectionDrug
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine lozenge | Experimental | Single dose administration of a 25 mg bupivacaine lozenge before the scaling and root planning was performed. Receives: Drug: Bupivacaine lozenge |
| Lidocaine-adrenalin injection | Active comparator | Xyloplyin Dental Adrenalin (20 mg/ml lidocaine, 12.5 microgram/ml adrenaline). Frequency and duration of injections was decided by the dentist preforming the scaling and root planning. Receives: Drug: Lidocaine-adrenalin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate a non-inferior effect on pain and discomfort during scaling and root planning by a bupivacaine lozenge in comparison to lidocaine-adrenalin injections.
Pain and discomfort are measured immediately after the scaling and root planning procedure
Level of pain:
-Visual Analog Scale (VAS) 0-10 where 0 = no pain, 10 = extreme pain
Measured: Day 1
To demonstrate a non-inferior effect on pain and discomfort during scaling and root planning by a bupivacaine lozenge in comparison to lidocaine-adrenalin injections.
Pain and discomfort are measured immediately after the scaling and root planning procedure
Level of discomfort:
-Visual Analog Scale (VAS) 0-10 where 0 = no discomfort, 10 = extreme discomfort
Measured: Day 1
Secondary outcomes (3)
Investigator evaluation of the scaling procedure
After the scaling and root planning the investigator evaluates the scaling procedure by a questionnaire
Measured: Day 1
Patient assessment of the two pharmaceutical formulations
After the scaling procedure the patient assesses the two pharmaceutical formulations by a questionnaire
Measured: Day 1
To demonstrate a non-inferior effect on pain and discomfort during scaling and root planning by a bupivacaine lozenge in comparison to lidocaine-adrenalin injections.
Pain and discomfort are measured immediately after the scaling and root planning procedure
Level of pain:
-McGills Pain Questionnaire (MPQ), which gives a qualitative pain profile
Measured: Daiy 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startNov 2012
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: Too slow patient inclusion and superior effect of the injection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain and Discomfort During Scaling and Root Planning of Patients WithStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ove Andersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ove Andersen, Hvidovre University Hospital
- Investigators
- Ove Andersen, MD, Study director, Hvidovre UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878864
- Sponsor's protocol ID
- OC004PDS
- Other IDs
- 2012-003430-16
- Status last verified
- Apr 2015
- First submitted
- 19 Apr 2013
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Anesthesia in Patients With Marginal Periodontitis Undergoing Scaling and Root Planning
- ClinicalTrials.gov ID
- NCT01878864
- Acronym / sponsor ID
- OC004PDS
- Keywords
- Pain, Discomfort, Periodontitis, Scaling and Root Planning, Visual Analogue Scale, McGills Pain Questionnaire
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too slow patient inclusion and superior effect of the injection
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ove AndersenUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 Jun 2013 (estimated)
- 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.
A randomised cross-over study comparing two methods of local anaesthesia for patients diagnosed with periodontitis undergoing scaling and root planning. 40 patients will be included in the study, which aims to demonstrate that the effect of a bupivacaine lozenge is non-inferior to lidocaine-adrenalin injections.
Detailed description
40 periodontitis patients undergoing scaling and root planning (SRP) will be randomised to receive local anaesthesia by either a bupivacaine lozenge or lidocaine-adrenalin injection at their first visit. At the following visit, the patients will receive the opposite treatment.
At each visit the patient will evaluate pain before, during and after SRP by:
- Visual Analog Scale (VAS) 0-10 where 0 = no pain, 10 = extreme pain.
- McGills Pain Questionnaire (MPQ), which gives a qualitative pain profile.
At each visit the patient will evaluate discomfort before, during and after the SRP by:
- Visual Analog Scale (VAS) 0-10 where 0 = no discomfort, 10 = extreme discomfort.
Additionally the patient assesses the comfort of administration of the two local anaesthesia as well as the taste of the bupivacaine lozenge. The investigator also evaluates the scaling procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine lozenge | Experimental | Drug: Bupivacaine lozengeSingle dose administration of a 25 mg bupivacaine lozenge before the scaling and root planning was performed. |
| Lidocaine-adrenalin injection | Active comparator | Drug: Lidocaine-adrenalin injectionXyloplyin Dental Adrenalin (20 mg/ml lidocaine, 12.5 microgram/ml adrenaline). Frequency and duration of injections was decided by the dentist preforming the scaling and root planning. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed as having, respectively periodontitis marginalis adulta progressiva lenta and periodontitis marginalis adulta progressiva rapid in the hygiene phase, where depurations are repeated within a short timeframe
- Age between 18 and 80 years
- Ability to speak, read and understand danish
- Ability to give oral and written consent
Key exclusion criteria (4 listed)
- Known allergy to bupivacaine or other local anaesthetics of the amide type
- Other gingival infections (eg lichen planus)
- Pregnancy -if in doubt a pregnancy test will be made
- Breastfeeding
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 |
|---|---|---|
| Bupivacaine lozenge | Drug | Bupivacaine lozenge |
| Lidocaine-adrenalin injection | Drug | Lidocaine-adrenalin injection |
Primary outcome
To demonstrate a non-inferior effect on pain and discomfort during scaling and root planning by a bupivacaine lozenge in comparison to lidocaine-adrenalin injections.
Time frame: Day 1
Pain and discomfort are measured immediately after the scaling and root planning procedure Level of pain: -Visual Analog Scale (VAS) 0-10 where 0 = no pain, 10 = extreme pain
To demonstrate a non-inferior effect on pain and discomfort during scaling and root planning by a bupivacaine lozenge in comparison to lidocaine-adrenalin injections.
Time frame: Day 1
Pain and discomfort are measured immediately after the scaling and root planning procedure Level of discomfort: -Visual Analog Scale (VAS) 0-10 where 0 = no discomfort, 10 = extreme discomfort
3 secondary outcomes
Investigator evaluation of the scaling procedure
Time frame: Day 1
Patient assessment of the two pharmaceutical formulations
Time frame: Day 1
To demonstrate a non-inferior effect on pain and discomfort during scaling and root planning by a bupivacaine lozenge in comparison to lidocaine-adrenalin injections.
Time frame: Daiy 1
Results and safety
The study was stopped early (reason given: Too slow patient inclusion and superior effect of the injection). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
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.
Ove Andersen, MD study director
Hvidovre UH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacaine lozenge and Lidocaine-adrenalin injection in people with Pain and Discomfort During Scaling and Root Planning of Patients With and Periodontitis, run by Ove Andersen at 3 sites in Denmark.
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 4 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: stopped early, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Too slow patient inclusion and superior effect of the injection). Results are not available in the source record.
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?
To demonstrate a non-inferior effect on pain and discomfort during scaling and root planning by a bupivacaine lozenge in comparison to lidocaine-adrenalin injections. (time frame: Day 1). 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 2015.