NCT06226740

Brief Summary

Aim: Evaluation of the effect of different obturation techniques on postoperative pain level and radiographic healing on non-surgical endodontic retreatment (NSER) applied in a single visit in teeth with single root canal and apical periodontitis (AP). Materials and Methods: 63 teeth with single-root canal and AP from 50 systemically healthy patients (mean age 34.19±9.75 years; 27 women, 23 men) were included in the study. Residual root canal filling materials were removed with retreatment files. All teeth were prepared using rotary files . The teeth were randomly divided into three groups according to the obturation technique; cold lateral compaction (CLC), continuous wave compaction (CWC), and gutta-core (TGC). Restorations are completed using direct composite resin in the same visit. In all cases, pain status were evaluated using the Numerical Pain Rating Scale (NRS) at preoperative, postoperative, 3rd hour, 24th hour, 48th hour, and 7th day. Periapical index (PAI) scores were recorded on preoperative and postoperative 6-month on the periapical radiographs for cases. Data were analyzed as statistically. Significance level was determined as p \< 0.05.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

December 4, 2023

Last Update Submit

January 18, 2024

Conditions

Keywords

warm vertical compactionsingle visitpostoperative painnon-surgical endodontic retreatmentcold lateral compactionnumeric rating scale

Outcome Measures

Primary Outcomes (2)

  • Evaluation of postoperative pain that may occur due to treatment

    In this study, postoperative pain observed after treatment was measured using the Numeric Rating Scale (NRS).

    1 week

  • Radiographic evaluation of healing of periapical tissues at 6 months after treatment

    In this study, periapical radiographs obtained using a parallel film holder before and after treatment of the patients included in the study were evaluated according to the Periapical Index (PAI) scores.

    6 months

Study Arms (3)

Cold Lateral Compaction (Control group)

EXPERIMENTAL

After the root canal preparation was completed, the working length was checked with the master cone and periapical radiography. The master cone was then covered with root canal sealer and placed in the root canal. Then, a gap was created for the .02 angled lateral cones using #30, 25 and 20 finger spreader. The obturation process continued until the spreader went 2 mm beyond the level of the canal orifice. Next, a hot excavator removed the coronal gutta-percha 1 mm below the canal orifice.

Other: Single Visit Non Surgical Root Canal Treatment Protocol

Warm Vertical Compaction

EXPERIMENTAL

After the root canal preparation was completed, the working length was checked with the master cone and periapical radiography. Root canal sealer was applied to the root canal walls using a master cone. HeatPlugger connected to the down-pack unit of the obturation system was adjusted to be 4 mm shorter than the working length. The master cone was cut 1 mm shorter than the working length with a heated plugger and applied to the root canal. Then, the heated plugger was advanced in the apical direction, and the apical region was obturated. Obturation was completed in 2 stages with gutta-percha in the gutta-percha cartridge connected to the remaining root canal cavity back-fill unit and heated to 200 °C. Heated gutta-percha was vertically condensed with HeatPlugger to 1 in the first stage and 2 in the second. The root canal obturation was completed by removing the gutta-percha 1 mm below the canal orifice.

Other: Single Visit Non Surgical Root Canal Treatment Protocol

Gutta Core

EXPERIMENTAL

After the root canal preparation was completed, the working length was controlled with the master cone and periapical radiography. Root canal sealer was applied to the root canal walls using a master cone. Root canal obturation was completed with heated gutta-percha according to the manufacturer's instructions. The heated gutta-percha was slowly inserted into the canal up to the working length. After cutting the handle of the obturators at the level of the canal orifice with a hot excavator, it was condensed into the canal using a gutta-percha plugger. The coronal gutta-percha was removed 1 mm below the canal orifice using a hot excavator.

Other: Single Visit Non Surgical Root Canal Treatment Protocol

Interventions

The current study aimed to compare the effects of different obturation techniques on postoperative pain level and radiographic healing in non-surgical endodontic treatment applied in a single visit in teeth with single root canal and apical periodontitis.

Cold Lateral Compaction (Control group)Gutta CoreWarm Vertical Compaction

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Teeth with previously endodontic treatment but unsuccessful and developing AP, root canal obturation 2 mm shorter than the working length and teeth that do not show adequate obturation,
  • Teeth with periapical lesion size less than 5mm,
  • Patient with the ages of 18-65,
  • Patient with dose not have systemic disease, does not use antihypertensive and antidiabetic drugs, does not have a pregnancy condition, does not use corticosteroids or antibiotics, mishaps
  • Patient with no acute pain or extraoral swelling,
  • Patient with no sinus tract and acute apical abscess,
  • Patients with who volunteered to participate in the study and agreed to attend the control visits were included.

You may not qualify if:

  • Teeth with internal or external root resorption,
  • Teeth with vertical root fracture or open apex,
  • Teeth with periapical lesion size more than 5 mm,
  • Patient with systemic disease,
  • Patient with systemic disorders related to bone metabolism and using drugs that may affect bone metabolism,
  • Patient with acute pain and therefore using analgesic medication in the last 24 hours,
  • Patient with using antibiotics 2 weeks before the treatment,
  • Patients who could not attend control sessions were excluded from the study .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant İzzet Baysal University

Bolu, Central, 14403, Turkey (Türkiye)

Location

Related Publications (1)

  • Isik M, Aydin ZU. Effect of different obturation techniques on treatment results in single-visit non-surgical endodontic retreatment: randomized controlled clinical study. BMC Oral Health. 2024 Nov 28;24(1):1449. doi: 10.1186/s12903-024-05240-3.

MeSH Terms

Conditions

Periapical PeriodontitisPain, PostoperativeTooth, Nonvital

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitisPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsDental Pulp DiseasesTooth Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Dr

Study Record Dates

First Submitted

December 4, 2023

First Posted

January 26, 2024

Study Start

September 17, 2021

Primary Completion

November 29, 2021

Study Completion

May 30, 2022

Last Updated

January 26, 2024

Record last verified: 2024-01

Locations