Can a mechanically controlled compression of the upper lip reduce the perception of pain during a local anesthetic injection in the mouth?

ISRCTN ISRCTN10930940
DOI https://doi.org/10.1186/ISRCTN10930940
Secondary identifying numbers 13/01/2016
Submission date
29/12/2019
Registration date
02/01/2020
Last edited
10/01/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
One of the most uncomfortable aspects of the dental appointment is the pain associated with the dental injection, which can cause anxiety and fear. Previous studies using this theoretical basis have shown that the vibration on the skin of the lip or different parts of the face can reduce the intensity of the pain coming from teeth or soft tissues. However, there have been no reports that quantify the effectiveness of using tissue compression near the puncture site in order to verify its efficacy in reducing pain perception during local dental anesthesia administration. Therefore, the aim of this study was to assess the effect of controlled compression of the upper lip on reducing the perception of pain during a local maxillary anesthetic injection.

Who can participate?
Dental students aged 18 years or older from Austral University of Chile Dental School

What does the study involve?
Participants will receive anesthetic using compression of the upper lip with wooden clothes peg and anesthetic without compression in a random order.

What are the possible benefits and risks of participating?
Benefits: The benefit is that the patient will perceive less pain at the time of the administration of the local anesthetic and will provide greater comfort for the dental treatment in the anesthetized area.
Risks: There are no major risks, only the risks inherent in any anaesthetic technique.

Where is the study run from?
Dental School, Faculty of Medicine, School of Dentistry, Austral University of Chile

When is the study starting and how long is it expected to run for?
June 2018 to November 2018

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Pedro Aravena
paravenat@gmail.com

Contact information

Dr Pedro Aravena
Public

Rudloff Street #1640
Valdivia
5110434
Chile

ORCiD logoORCID ID 0000-0003-1230-4573
Phone +56 632221205
Email paravena@uach.cl

Study information

Study designSplit-mouth randomized clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEffect of upper lip compression on pain control during local maxillary anesthesia. A Split-mouth randomized clinical trial
Study objectivesUpper lip compression reduces pain perception during a local maxillary anesthetic injection
Ethics approval(s)Approved 13/01/2016, Ethical Committee of Faculty of Medicine. Universidad Austral de Chile (Austral University of Chile, Medicine Faculty, Campus Isla Teja S/N, Valdivia, 5110434 - Chile; +56 63 2221324; facmed@uach.cl), ref: n/a
Health condition(s) or problem(s) studiedLocal maxillary anesthetic injection
InterventionTo determine the chronological order of the injection for to control the measurement bias and placebo effect of lip compression, a randomization process within subject was performed using software available at http://www.sealedenvelope.com by a staff member not involved in the research protocol, who recorded the details of the allocated group on cards contained in sequentially opaque, numbered and sealed envelopes. The allocation assignment was revealed by opening the envelope immediately before of the procedure, where cards containing one of two colors were used, indicating the primary intervention: red meant anesthetic using compression with wooden clothes peg and white card meant anesthetic without compression. Thus, the concealment of the random sequence was guaranteed, in order to prevent selection bias.
In order to control for the effect different time may have an influence on the pain perception, all measurement was applied between 10:00 to 12:00 hours of the day. In preparation for the anesthetic, the volunteers rinsed with a mouthwash of 0.12% chlorhexidine (OralgeneTM, MaverPharma. Chile) and were positioned in the dental chair as described by Malamed for local maxillary anesthetic techniques. One investigator (JL) prepared the carpule syringe using a 30G short needle (Septoject XL, SeptodontTM. Saint-Maur-des-Fossés, Francie) and a Xylonor 2% special anesthesia cartridge (SeptodontTM) at room temperature. For the volunteer selected for anesthesia with lip compression, the investigator responsible for the anesthetic technique, trained and with 10 years of experience in the dental emergency service (PCA), placed the wooden clothes peg on the upper lip at the level of the left upper canine, separating the lip with the use of a dental mirror, next to the puncture site and immediately performed the anesthetic technique according to the recommendations made by Malamed, placing the needle parallel to the lateral incisor and going down to one centimeter from the bottom of the buccal plate, depositing a third (0.6 ml) of the contents of the anesthesia cartridge within 15 seconds. Immediately after withdrawing the needle, the second investigator (JL) presented the volunteer with a card with the VAS, asking “How much pain did you perceive during the puncture and administration of the anesthesia?” and registering the value indicated. The principal investigator did not participate in the collecting or recording of the data. After two weeks (the washout period), the second injection was done on the contralateral side of the maxilla with the same technique and the complementary intervention according to the randomization sequence described.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase IV
Drug / device / biological / vaccine name(s)Xilonor 2% (2% Lidocaine with 1:100.000 Epinephrine)
Primary outcome measureThe level of pain perceived by the volunteer on the Visual Analogue Scale (VAS) during the anesthetic injection recorded at the time of injection
Secondary outcome measuresCovariance of the main outcome (pain perception during anaesthetic injection) according to variables such as sex and age of participants.
Overall study start date01/03/2016
Completion date30/11/2016

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants72
Total final enrolment72
Key inclusion criteria1. Aged 18 years or older
2. Signed informed consent form
Key exclusion criteria1. History of allergies or adverse reactions to local anesthesia
2. Presence of dental pain because of dental or orthodontic treatment one month prior to the study
3. Infection in the puncture area
4. Pharmacological treatment with non-steroidal anti-inflammatory drugs (NSAIDs), benzodiazepines or antidepressants
Date of first enrolment01/04/2016
Date of final enrolment30/06/2016

Locations

Countries of recruitment

  • Chile

Study participating centre

Dental School, Faculty of Medicine, School of Dentistry
Austral University of Chile
Valdivia
5110434
Chile

Sponsor information

Austral University of Chile
University/education

Rudloff Street #1640
Valdivia
5110434
Chile

Phone +56 632212942
Email paravena@uach.cl
Website https://www.uach.cl/admision/principal/va1divia/odontologia
ROR logo "ROR" https://ror.org/029ycp228

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/03/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planThe purpose is to publish the results in "Patients Preference and Adherence" or "Journal of Oral And Maxillofacial Surgery".
IPD sharing planAll data generated or analysed during this study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file 10/01/2020 No No

Additional files

ISRCTN10930940_PROTOCOL_(Spanish)_2015.pdf
Uploaded 10/01/2020

Editorial Notes

10/01/2020: Uploaded protocol (not peer reviewed).
31/12/2019: Trial’s existence confirmed by Ethical Committee of Faculty of Medicine. Universidad Austral de Chile