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Effect of Local Anesthesia in Patients With Marginal Periodontitis Undergoing Scaling and Root Planning

Information source: Hvidovre University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain and Discomfort During Scaling and Root Planning of Patients With; Periodontitis

Intervention: Bupivacaine lozenge (Drug); Lidocaine-adrenalin injection (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Ove Andersen

Official(s) and/or principal investigator(s):
Ove Andersen, MD, Study Director, Affiliation: Hvidovre UH

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.

Clinical Details

Official title: Effect of Local Anesthesia in Patients With Marginal Periodontitis Undergoing Scaling and Root Planning

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

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.

Secondary outcome:

Investigator evaluation of the scaling procedure

Patient assessment of the two pharmaceutical formulations

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.

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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Locations and Contacts

Tandlægerne Vimmelskaftet, Copenhagen K 1161, Denmark

Frederiksberg Tandlægerne, Frederiksberg 2000, Denmark

Tandlægepraksis ved Jonna Bork, Hvidovre 2650, Denmark

Additional Information

Starting date: November 2012
Last updated: April 1, 2015

Page last updated: August 23, 2015

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