FE in Anterior Teeth

Enlargement of Apical Foramen in Anterior Teeth With Apical Periodontitis and Postoperative Pain and Flare-up Rate.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03527602

Enrollment

Registered

2018-05-17

Start date

2017-11-05

Completion date

2018-08-05

Last updated

2018-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apical Periodontitis, Pain, Postoperative

Keywords

Apical patency, Endodontics

Brief summary

The purpose of this study is to determine whether enlarging the apical foramen causes postoperative pain in maxillary anterior teeth with apical periodontitis.

Detailed description

Foraminal enlargement (FE) is an intentional procedure that enlarges the cement canal. However, some RCTs indicate that enlarging the FE causes postoperative pain, flare-up, and destroy the apical constriction, whilst some RCTs pointed out there is no difference in terms of pain when a FE has been performed in maxillary anterior teeth with apical periodontitis. We will assess the risk of postoperative pain as risk ratio (RR). The binary (dichotomous) data: 0-44 mm: Mild or no pain; 45-100 mm: Moderate to severe pain.

Interventions

PROCEDUREForaminal enlargement

After determining the working length, a rotary file will be inserted 1 mm beyond the WL and the apical foramen will be enlarged.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

Single-blind. (Participants)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Mature permenent maxillary anterior teeth having pulpal necrosis and apical periodontitis.

Exclusion criteria

Systemic disorders, diabetes, pregnancy, less than 18 years of age, immunocompromised, patients who had taken antibiotics in the past 1 month, patients who had a positive history of analgesic use within the past 3 days, previously accessed teeth.

Design outcomes

Primary

Measure	Time frame	Description
100-mm Visual Analog Scale (VAS).	5 days	The severity of pain in 12 h, 24 h, and 2, 3, 4, and 5 days according to the VAS: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)

Secondary

Measure	Time frame	Description
The number of patients taking an analgesic following the endodontics treatment.	5 days	The patients were asked to take an analgesic in the 5 days of time frame.

Countries

Turkey (Türkiye)

Contacts

Primary Contactibrahim Ethem Yaylali, PhD

ibotenring@yahoo.com05378707924

Backup Contactibrahim E Yaylali, PhD