Evaluation of the adequacy of anesthesia achieved by 4% Articaine buccal infiltration during extraction of lower premolars for orthodontic purpose

Not yet recruiting

Conditions: Other specified disorders of teethand supporting structures,
M26.4MALOCCLUSION: Requiring extraction of mandibular premolars

Registration Number: CTRI/2022/08/044724

Lead Sponsor: Dasmesh Institute Of Research and Dental Sciences Faridkot

Brief Summary: 1.    Patients who fulfil inclusion criteria will be selected

2.    The study design will be discussed with every selected subject

3.    Informed written consent will be obtained

4.    Patients will be seated on the dental chair and explained about VAS and verbal satisfaction score & pinprick score before starting the procedure

5.    All the extractions will be done by single surgeon

6.    Each patient will be asked to rinse the oral cavity with chlorhexidine mouthwash(0.2%) for 30 seconds

7.    Under aseptic conditions, peri-oral area will be scrubbed using 5% povidine iodine solution and patient will be draped with sterile sheets

8.    Injection site will be cleaned with sterile gauze

9.    A 27gauge needle attached to dental syringe and cartridge will be used for buccal infiltration. To deliver lingual infiltration a sterile disposable insulin syringe will be used

10. Patients under the study: Group I- will receive buccal infiltration of 1.8 ml 4% articaine with 1:100000 epinephrine plus lingual infiltration of 0.4 ml 4% articaine and Group II- will receive buccal infiltration of 1.8 ml 4% articaine with 1:100000 epinephrine plus lingual infiltration of 0.4 ml normal saline (placebo).

11. Patient will be informed to report the numbness of lip as soon as they feel

12. After 5 minutes the buccal and lingual gingiva will be examined using a pinprick test (with probe). Lingual anesthesia will be assessed on 5-score verbal scale. Whenever pain experienced by the patient will be reported as "obviate" (score 2) or more, it will be considered as a failure of the buccal infiltration and additional infiltration of articaine will be given lingually and we will wait for additional 5 minutes before continuing the procedure

13. Intra-alveolar (forceps) technique will be used for the extraction after routine tooth luxation by dental elevator

14. Care will be taken to ensure minimal trauma to the surrounding tissue

15. Pain will be assessed on VAS during extraction

16. Patients will be asked to rate the degree of their satisfaction on the verbal scale after extraction

17. Time taken to complete the procedure will be recorded

18. Post operative instructions will be given and analgesic will be prescribed

The values will be tabulated and results will be derived

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

1.Age group of 15 to 25 2.Patients who want extraction of both left and right mandibular premolars 3.Patients belonging to ASA class I and II 4.Patients who grant consent to be a part of the study.

Exclusion Criteria

History of allergy to local anesthetic agents 2.
History of uncontrolled diabetes mellitus, hypertension, or renal diseases 3.
Patients on central nervous system depressants including alcohol or any analgesic medication within the last 48 hours 4.
Pregnant and lactating females 5.
Patients having abscess or any other lesion at the injection site.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To assess the amount of pain perceived on Visual Analogue Scale of 10cm length (VAS-10).	5 minutes after giving anesthetic, during extraction of tooth.
2.To assess the profoundness of lingual anesthesia: It will be determined by degree of sensibility of lingual mucosa to pin prick test on a 5-score verbal scale	5 minutes after giving anesthetic, during extraction of tooth.

Secondary Outcome Measures

Name	Time	Method
Time taken for extraction and patient satisfaction	just after completion of procedure

Trial Locations

Locations (1): Dasmesh Institute Of Research and Dental Sciences, Faridkot
🇮🇳
Faridkot, PUNJAB, India
Dasmesh Institute Of Research and Dental Sciences, Faridkot
🇮🇳Faridkot, PUNJAB, India
Ramandeep Singh Brar
Principal investigator
8146669520
dr.ramanbrar@yahoo.com