Irreversible PulpitisPhase 3NCT02807298
4% Articaine and 2% Lidocaine by Intraligamentary Technique in Irreversible Pulpitis
A Phase 3 study testing 4%articaine, 2% Lignocaine and Epinephrine in people with Irreversible Pulpitis, run by Dr. D. Y. Patil Dental College & Hospital.
Trial summary
This study compared the anesthetic efficacy between Lignocaine and articaine administering it intraligamentarly using ligajet in twenty five female patients having irreversible pulpitis on bilateral mandibular molars. At 5minutes of post injection, the teeth were isolated with rubber dam and access performed. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- 4%articaine, 2% Lignocaine and Epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Dec 2014
- Phase
- Phase 3
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Irreversible pulpitis in the bilateral first or second mandibular molars.
- Absence of periapical radiolucency on the periapical radiographs(except for periapical widening) confirmed the presence of irreversible pulpitis in the teeth.
Who cannot join
- Pregnant women,
- Patients with systemic disease .
- Teeth with Previous endodontic therapy, large restorations, full crowns, periodontal diseases, or restoration with poor margins were eliminated from the study.
- Also teeth with a history of trauma or sensitivity were eliminated.
- Patients taken antibiotics or analgesics in previous 3 months
About this study
This study compared the anesthetic efficacy between Lignocaine and articaine administering it intraligamentarly using ligajet in twenty five female patients having irreversible pulpitis on bilateral mandibular molars. At 5minutes of post injection, the teeth were isolated with rubber dam and access performed. Patients were instructed to definitively rate any pain felt during endodontic procedure. If patient felt pain, the treatment was immediately stopped and the patient rated their discomfort using Heft Parker VAS. The extent of access achieved when the patient felt pain was recorded as within dentin, entering the pulp chamber or initial file placement. The success was defined as the ability to access and instrument the tooth without pain (VAS score of zero) or mild pain (VAS rating<54mm).
Read the detailed description
The present clinical study was carried out to compare the anaesthetic success of 4% articaine with 2% lidocaine for intraligamentary anaesthesia in patients having irreversible pulpitis.
Subjects randomly received two intraligamentary injections using Ligaject at a two separate appointments spared one week apart in a cross over design. Twenty patients received intraligamentary injections of 0.9 ml of 4%articaine with 1:100,000 epinephrine (Septodont INC) at first appointment and 1.8 ml of lidocaine with 1:100,000 epinephrine. Each patient served as her own control. All injections were given by the same physician or author. The injection was performed by inserting the needle at the gingival sulcus at the mesio-buccal line angle of the tooth with needle directed at approximately 30degrees angle to the long axis of the tooth in the buccolingual plane. Needle was placed into the sulcus with the bevel placing away from the tooth and towards the alveolar bone. Needle was advanced with a firm pressure until it could be advanced no further.
The operator waited 10 seconds before slowly removing the needle from the injection site. This step supposedly allows the anaesthetic solution to dissipate within the tissue and reduces the amount of anaesthetic solution to dissipate within the tissue and reduces the amount of solution dripping from the site before needle withdrawal. However, in almost all cases some anaesthetic solution escaped upon removal of needle from the sulcus.
Five minutes post injection, the teeth were isolated under rubber dam isolation and investigator performed the access cavity. Patients were instructed to definitely rate any pain felt during endodontic procedure. If patient felt pain, the treatment was immediately stopped and the patient rated her discomfort using Heft Parker VAS. The extent of access achieved when the patient felt pain was recorded as within dentin, entering the pulp chamber or initial file placement. The success was defined as the ability to access and instrument the tooth without pain (VAS score of zero) or mild pain (VAS rating<54mm).
- Conditions
- Irreversible Pulpitis
- Being tested
- 4%articaine, 2% Lignocaine, Epinephrine
- Keywords
- Intarligamentary, Articaine, Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4%articaineDrug
intraligamentary injections of 0.9 ml of 4%articaine and 1:100,000 epinephrine
2% LignocaineDrug
Intraligamentary injections of 1.8 ml of lidocaine and 1:100,000 epinephrine
EpinephrineDrug
Intraligamentary injections of 1.8 ml of lidocaine and 1:100,000 epinephrine
| Study group | Role | What they receive |
|---|---|---|
| 2% Lignocaine (lidocaine) | Active comparator | Intraligamentary injections of 1.8 ml of lidocaine and 1:100,000 epinephrine (adrenaline) Receives: Drug: 2% Lignocaine; Drug: Epinephrine |
| 4% Articaine | Experimental | intraligamentary injections of 0.9 ml of 4%articaine and 1:100,000 epinephrine (adrenaline) Receives: Drug: 4%articaine; Drug: Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scale as measured by The Heft Parker Visual scale (HP-VAS)
HP-VAS was a 170mm line divided into different categories of pain. Different marks on the line show a description of a certain pain level. Absence of pain corresponded to 0mm. mild pain with the descriptors of faint, weak, and mild pain corresponded to 0mm to 54mm, Moderate pain corresponded to greater than 54mm upto 114mm, and Severe pain with the descriptors of strong, intense, and maximum possible amount of pain corresponded to greater than 114mm upto 170mm. Patients were asked to rate their initial pain on a HP-VAS,
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startJun 2014
- Primary completionOct 2014
- Study completionDec 2014
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 Irreversible PulpitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. D. Y. Patil Dental College & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soumya Shetty, Dr. D. Y. Patil Dental College & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807298
- Sponsor's protocol ID
- DYPDCH/IEC-SS/18/2014
- Status last verified
- Jun 2016
- First submitted
- 9 Jun 2016
- Last updated
- 21 Jun 2016
- Results posted
- No
Publications
Malamed SF, Gagnon S, Leblanc D. A comparison between articaine HCl and lidocaine HCl in pediatric dental patients. Pediatr Dent. 2000 Jul-Aug;22(4):307-11.
PubMed 10969438Vahatalo K, Antila H, Lehtinen R. Articaine and lidocaine for maxillary infiltration anesthesia. Anesth Prog. 1993;40(4):114-6.
PubMed 7943919