PeriodontitisPhase 4NCT03354312
Acceptance and Preference of Lidocaine Gel Compared to Injection Anesthesia After Non Surgical Periodontal Treatment
A Phase 4 study testing Lidocaine Hydrochloride 1% Gel and Articaine hydrochloride/epinephrine (adrenaline) hydrochloride in people with Periodontitis, run by Chemische Fabrik Kreussler & CO GmbH at 5 sites in Germany.
Trial summary
This project is a national, open label, multicenter, randomized split-mouth study in patients from 18 to 70 years of age to compare the efficacy and acceptability of lidocaine gel compared to injection anesthesia with articaine (infiltration anesthesia for the upper jaw and infiltration or nerve block anesthesia for… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Lidocaine Hydrochloride 1% Gel and Articaine hydrochloride/epinephrine (adrenaline) hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 5 sitesGermany
- Study dates
- 5 Dec 2017to 2 Nov 2018
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent must be available
- Willingness and ability to comply with scheduled visits, treatment plan, and other study procedures
- Patient systemically healthy except for controlled diabetes and hypertension
- Patients with comparable periodontal status of the right and left jaw, with ≥ 3 teeth with pockets ≥ 4 mm and ≤ 7 mm per quadrant
- Female patients of childbearing potential must practice highly effective contraception methods
Who cannot join
- Generalized severe periodontitis with pockets > 8 mm
- More than 2 pockets > 7 mm and ≤ 8 mm per quadrant
- Contraindicated for treatment with the investigational product, the comparator drug, or meet warnings and precautions for use specifications in accordance with the approved SmPCs as follows:
- Hypersensitivity to the investigational product, the comparator drug or to any of their respective excipients
- Hypersensitivity to other local anesthetics of the amide type
- Severe uncontrolled and untreated excitation and conduction disorder of the heart
Show all 28Show fewer
- Acute decompensated heart failure
- Severe renal or hepatic disease/dysfunction
- Untreated or uncontrolled diabetes type 2
- Severe hypertension and severe hypotension
- Narrow-angle glaucoma
- Hyperthyroidism
- Paroxysmal tachycardia or high-frequency absolute arrhythmia
- Myocardial infarction within the last 6 months
- Coronary artery bypass within the last 3 months
- Concurrent use of non-cardio selective beta blockers (e.g. propranolol)
- Pheochromocytoma
- Concurrent treatment with tri-cyclic antidepressants or monoamine oxidase (MAO) inhibitors
- Use of painkillers or anti-inflammatory drugs 24 hours before the first treatment
- Antibiotic prophylaxis or treatment with antibiotics
- Use of any anxiolytic medication
- Periodontal treatment within the last 3 months
- Continuing orthodontic treatment
- Concurrent use of another investigational medication
- Participation in another clinical trial within the last 3 months
- Women who are pregnant or breastfeeding, or planning pregnancy while enrolled in the study
- Persons who are in a dependency or working relationship with the sponsor or investigator
- A subject who, in the opinion of the investigator will be uncooperative or unable to comply with study procedures
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Charité - Universitätsmedizin Berlin Charité Centrum Zahn-, Mund- und Kieferheilkunde CC 3
Berlin, 14197
Universitätsklinikum Schleswig-Holstein, Klinik für Zahnerhaltungskunde und Parodontologie
Kiel, Schleswig-Holstein, 24105
Universitätsklinikum Giessen und Marburg GmbH, Standort Marburg
Marburg, Hesse, 35033
Praxis Dr. Heckel
Röttenbach, Bavaria, 91341
Praxis Dr. Petersilka
Würzburg, Bavaria, 97070
About this study
Official title: Multicenter, Randomized, Split-mouth Study to Evaluate the Acceptance and Preference of Lidocaine Gel Compared to Injection Anesthesia After Non Surgical Periodontal Treatment
This project is a national, open label, multicenter, randomized split-mouth study in patients from 18 to 70 years of age to compare the efficacy and acceptability of lidocaine gel compared to injection anesthesia with articaine (infiltration anesthesia for the upper jaw and infiltration or nerve block anesthesia for the lower jaw). It is planned that about 90 patients with a proven moderate periodontitis will be enrolled in 5 German study centers.
Dynexan Mundgel® (lidocaine hydrochloride) is a topical anesthetic gel containing lidocaine that is commercially available as an anesthetic for temporary, symptomatic treatment of pain at the oral mucosa, gingiva and lips. The gold standard for scaling and root planing (SRP) is still the use of injection anesthesia. This raises the question what kind of anesthesia patients would prefer if they had a free choice.
For this study Ultracaine® D-S 1:200,000 (articaine hydrochloride/epinephrine hydrochloride) was selected as the injectable comparator drug because it is the most frequently used anesthetic drug for infiltration and nerve-block anesthesia in Germany at present.
- Conditions
- Periodontitis
- Being tested
- Lidocaine Hydrochloride 1% Gel, Articaine hydrochloride/epinephrine (adrenaline) hydrochloride
- Keywords
- scaling and root planing, topical anesthesia
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine Hydrochloride 1% GelDrug
Also called Dynexan Mundgel®
Cylinder vials with 1.7 g gel containing 34 mg lidocaine (1 g gel contains 20 mg lidocaine) will be used. Application of the gel into the periodontal pockets or the sulcus according to summary of product characteristics (SmPC). A total dose of 40 mg lidocaine should not be exceeded.
Articaine hydrochloride/epinephrine (adrenaline) hydrochlorideDrug
Also called Ultracain® D-S 1:200,000
Cylinder vials with 1.7 ml solution for injection containing 68 mg articaine and 0.0102 mg epinephrine (1 ml contains 40 mg articaine and 0.006 mg epinephrine) will be used. Infiltration anesthesia for the upper jaw and infiltration or nerve block anesthesia for the lower jaw with articaine solution for injection according to SmPC. Adults can be treated with up to 7 mg articaine per kg of body weight per treatment session.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine/Articaine | Experimental | Lidocaine Hydrochloride 1% Gel anesthesia / Articaine hydrochloride/epinephrine (adrenaline) hydrochloride anesthesia Receives: Drug: Lidocaine Hydrochloride 1% Gel; Drug: Articaine hydrochloride/epinephrine (adrenaline) hydrochloride |
| Articaine/Lidocaine | Experimental | Articaine hydrochloride/epinephrine (adrenaline) hydrochloride anesthesia / Lidocaine Hydrochloride 1% Gel anesthesia Receives: Drug: Lidocaine Hydrochloride 1% Gel; Drug: Articaine hydrochloride/epinephrine (adrenaline) hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance and preference of topical lidocaine mouth gel anesthesia
To compare acceptance and preference of topical lidocaine mouth gel anesthesia vs. injection anesthesia with articaine in patients undergoing subgingival debridement by comparing the proportion of patients after the second periodontal treatment who prefer topical anesthesia with lidocaine gel against the injection anesthesia with articaine to a proportion of 0.5; the patient rates the preferred anesthesia method on a questionnaire by stating if the patient's preference is treatment with anesthetic gel, treatment with anesthetic injection, or no preference
Measured: 1 hour post-dose of second treatment
Secondary outcomes (11)
Assessment of pain
Comparative assessment of pain the patients experienced during treatment; a visual analogue scale (100mm, 0 = no pain, 100 = maximum pain) will be used for maximum pain and average pain Rating after each treatment visit
Measured: 1 hour post-dose
Side Effects
Evaluate type and number of side effects (incl. after-effects due to study Treatment up to 24h after each treatment visit by use of a patient diary)
Measured: 1, 5, 25 hours post-dose
Handling/Application
Compare the handling/application of both methods; the treating physician rates the handling/application on a questionnaire by using German school grades (1 = very good, 2 = good, 3 = satisfactory, 4 = adequate, 5 = inadequate, 6 = insufficient) after each treatment visit.
Measured: 1 hour post-dose
Onset of anesthetic effect
Compare the onset of anesthetic effect in both treatment groups; the treating physician rates the onset of the anesthetic effect on a questionnaire by using German school grades (1 = very good, 2 = good, 3 = satisfactory, 4 = adequate, 5 = inadequate, 6 = insufficient) after each treatment visit.
Measured: 1 hour post-dose
Duration of anesthetic effect
Compare the duration of anesthetic effect in both treatment groups; the treating physician rates the duration of the anesthetic effect on a questionnaire by using German school grades (1 = very good, 2 = good, 3 = satisfactory, 4 = adequate, 5 = inadequate, 6 = insufficient) after each treatment visit.
Measured: 1 hour post-dose
Patient compliance
Compare the patient compliance in both treatment groups; the treating physician rates the patient compliance on a questionnaire by using German school grades (1 = very good, 2 = good, 3 = satisfactory, 4 = adequate, 5 = inadequate, 6 = insufficient) after each treatment visit.
Measured: 1 hour post-dose
Treating physicians preference
Evaluation which of the anesthetic methods the treating physician prefers. The treating physician rates the preferred anesthesia method on a questionnaire by stating if the treating physician's preference is treatment with anesthetic gel, treatment with anesthetic injection, or no preference
Measured: 1 hour post-dose of second treatment
Anesthesia re-application/rescue anesthesia
Assess the number of re-application of the anesthetic gel or the rescue anesthesia injections that are required in every treatment group
Measured: 1 hour post-dose
Overall patient satisfaction with anesthesia
Evaluation of the overall patient satisfaction with anesthesia. The patient rates the overall satisfaction on a questionnaire by using German school grades (1 = very good, 2 = good, 3 = satisfactory, 4 = adequate, 5 = inadequate, 6 = insufficient) after each treatment visit.
Measured: 1 hour post-dose
Willingness to pay
Evaluation of the willingness to pay for lidocaine gel by using a questionnaire (willingness to pay 0, 1-5, 5-10, 10-15, 15-20 or >20 €)
Measured: 1 hour post-dose of second treatment
Re-Evaluation of patients preference
Re-evaluation of preference of topical lidocaine mouth gel anesthesia vs. injection anesthesia with articaine 24 h after end of last treatment. The patient again rates the preferred anesthesia method by stating if his/her preference is treatment with anesthetic gel, treatment with anesthetic injection, or no preference. The preference 24 h after end of last treatment is collected by using the patient diary.
Measured: 25 hours post-dose of second treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start5 Dec 2017
- Primary completion2 Nov 2018
- Study completion2 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The randomization determines if a subject will be assigned to receive either lidocaine gel or articaine injection anesthesia as the first anesthesia during SRP Treatment of the right upper and lower jaw. The second anesthesia during SRP at visit 2 will be carried out with the remaining anesthetic on the left side of the upper and lower jaw.
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chemische Fabrik Kreussler & CO GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Anfomed GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354312
- Sponsor's protocol ID
- DyMZIS-01
- Status last verified
- Dec 2018
- First submitted
- 14 Nov 2017
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dorfer C, Chmiela K, Arweiler NB, Petersilka GJ, Dommisch H, Heckel R, Kahl M, Kuzmanova D, Purucker P, Springer C. Evaluation of acceptance and preference of topical lidocaine application versus articaine injection anesthesia after nonsurgical periodontal treatment: A randomized clinical trial. J Periodontol. 2024 Sep;95(9):821-831. doi: 10.1002/JPER.23-0466. Epub 2024 Apr 2.
PubMed 38563593
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Split-mouth Study to Evaluate the Acceptance and Preference of Lidocaine Gel Compared to Injection Anesthesia After Non Surgical Periodontal Treatment
- ClinicalTrials.gov ID
- NCT03354312
- Acronym / sponsor ID
- DyMZIS-01
- Conditions
- Periodontitis
- Keywords
- scaling and root planing, topical anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Chemische Fabrik Kreussler & CO GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Anfomed GmbH
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 27 Nov 2017 (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 project is a national, open label, multicenter, randomized split-mouth study in patients from 18 to 70 years of age to compare the efficacy and acceptability of lidocaine gel compared to injection anesthesia with articaine (infiltration anesthesia for the upper jaw and infiltration or nerve block anesthesia for the lower jaw). It is planned that about 90 patients with a proven moderate periodontitis will be enrolled in 5 German study centers.
Dynexan Mundgel® (lidocaine hydrochloride) is a topical anesthetic gel containing lidocaine that is commercially available as an anesthetic for temporary, symptomatic treatment of pain at the oral mucosa, gingiva and lips. The gold standard for scaling and root planing (SRP) is still the use of injection anesthesia. This raises the question what kind of anesthesia patients would prefer if they had a free choice.
For this study Ultracaine® D-S 1:200,000 (articaine hydrochloride/epinephrine hydrochloride) was selected as the injectable comparator drug because it is the most frequently used anesthetic drug for infiltration and nerve-block anesthesia in Germany at present.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The randomization determines if a subject will be assigned to receive either lidocaine gel or articaine injection anesthesia as the first anesthesia during SRP Treatment of the right upper and lower jaw. The second anesthesia during SRP at visit 2 will be carried out with the remaining anesthetic on the left side of the upper and lower jaw.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine/Articaine | Experimental | Drug: Lidocaine Hydrochloride 1% Gel, Drug: Articaine hydrochloride/epinephrine (adrenaline) hydrochlorideLidocaine Hydrochloride 1% Gel anesthesia / Articaine hydrochloride/epinephrine (adrenaline) hydrochloride anesthesia |
| Articaine/Lidocaine | Experimental | Drug: Lidocaine Hydrochloride 1% Gel, Drug: Articaine hydrochloride/epinephrine (adrenaline) hydrochlorideArticaine hydrochloride/epinephrine (adrenaline) hydrochloride anesthesia / Lidocaine Hydrochloride 1% Gel anesthesia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent must be available
- Willingness and ability to comply with scheduled visits, treatment plan, and other study procedures
- Patient systemically healthy except for controlled diabetes and hypertension
- Patients with comparable periodontal status of the right and left jaw, with ≥ 3 teeth with pockets ≥ 4 mm and ≤ 7 mm per quadrant
- Female patients of childbearing potential must practice highly effective contraception methods
Key exclusion criteria (28 listed)
- Generalized severe periodontitis with pockets > 8 mm
- More than 2 pockets > 7 mm and ≤ 8 mm per quadrant
- Contraindicated for treatment with the investigational product, the comparator drug, or meet warnings and precautions for use specifications in accordance with the approved SmPCs as follows:
- Use of painkillers or anti-inflammatory drugs 24 hours before the first treatment
- Antibiotic prophylaxis or treatment with antibiotics
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 |
|---|---|---|
| Lidocaine Hydrochloride 1% GelAlso: Dynexan Mundgel®Cylinder vials with 1.7 g gel containing 34 mg lidocaine (1 g gel contains 20 mg lidocaine) will be used. Application of the gel into the periodontal pockets or the sulcus according to summary of product characteristics (SmPC). A total dose of 40 mg lidocaine should not be exceeded. | Drug | Articaine/Lidocaine, Lidocaine/Articaine |
| Articaine hydrochloride/epinephrine (adrenaline) hydrochlorideAlso: Ultracain® D-S 1:200,000Cylinder vials with 1.7 ml solution for injection containing 68 mg articaine and 0.0102 mg epinephrine (1 ml contains 40 mg articaine and 0.006 mg epinephrine) will be used. Infiltration anesthesia for the upper jaw and infiltration or nerve block anesthesia for the lower jaw with articaine solution for injection according to SmPC. Adults can be treated with up to 7 mg articaine per kg of body weight per treatment session. | Drug | Articaine/Lidocaine, Lidocaine/Articaine |
Primary outcome
Acceptance and preference of topical lidocaine mouth gel anesthesia
Time frame: 1 hour post-dose of second treatment
To compare acceptance and preference of topical lidocaine mouth gel anesthesia vs. injection anesthesia with articaine in patients undergoing subgingival debridement by comparing the proportion of patients after the second periodontal treatment who prefer topical anesthesia with lidocaine gel against the injection anesthesia with articaine to a proportion of 0.5; the patient rates the preferred anesthesia method on a questionnaire by stating if the patient's preference is treatment with anesthetic gel, treatment with anesthetic injection, or no preference
11 secondary outcomes
Assessment of pain
Time frame: 1 hour post-dose
Side Effects
Time frame: 1, 5, 25 hours post-dose
Handling/Application
Time frame: 1 hour post-dose
Onset of anesthetic effect
Time frame: 1 hour post-dose
Duration of anesthetic effect
Time frame: 1 hour post-dose
Patient compliance
Time frame: 1 hour post-dose
Treating physicians preference
Time frame: 1 hour post-dose of second treatment
Anesthesia re-application/rescue anesthesia
Time frame: 1 hour post-dose
Overall patient satisfaction with anesthesia
Time frame: 1 hour post-dose
Willingness to pay
Time frame: 1 hour post-dose of second treatment
Re-Evaluation of patients preference
Time frame: 25 hours post-dose of second treatment
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 20 Dec 2018.
- Derived from this study: PubMed 38563593Dorfer C, Chmiela K, Arweiler NB, Petersilka GJ, Dommisch H, Heckel R, Kahl M, Kuzmanova D, Purucker P, Springer C. Evaluation of acceptance and preference of topical lidocaine application versus articaine injection anesthesia after nonsurgical periodontal treatment: A randomized clinical trial. J Periodontol. 2024 Sep;95(9):821-831. doi: 10.1002/JPER.23-0466. Epub 2024 Apr 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine Hydrochloride 1% Gel and Articaine hydrochloride/epinephrine (adrenaline) hydrochloride in people with Periodontitis, run by Chemische Fabrik Kreussler & CO GmbH at 5 sites in Germany.
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 5 inclusion and 28 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 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
Acceptance and preference of topical lidocaine mouth gel anesthesia (time frame: 1 hour post-dose of second treatment). 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 NCT03354312, which also lists 1 linked publication.
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 20 Dec 2018.