Postoperative Symptoms Following Endodontic Microsurgery

NCT05898035 | Recruiting

• 1 other identifier: KingAbdullahUH
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Aims: The purpose of this randomized clinical trial is to assess and compare the post operative pain, swelling and quality of life after endodontic microsurgery using either conventional osteotomy or piezoelectric osteotomy . The PICO question that will be used is Does endodontic microsurgery using piezoelectric osteotomy have similar clinical performance in terms of post operative pain and swelling to that of endodontic microsurgery using conventional hand-piece osteotomy. Material and methods: based on solid inclusion criteria , a total of 44 patients in need of endodontic microsurgery will be randomly distributed into two groups (n=22) according to the osteotomy technique: conventional and piezoelectric osteotomy. A standardized microsurgical technique will be employed. After the microsurgery procedure, a pain questionnaire that contain visual analogue scale will be given to each patient to evaluate the pain incidence and intensity at 5 time intervals, 24 hours, 48 hours, 72 hours, 96 hours and 120 hours. The patients will be recalled as well, at days 2 and 7 to evaluate the swelling. Statistical analysis will be performed using chi-square test and linear regression analysis.

Conditions

Pain Postoperative; Swelling Lips & Face

Keywords

Microsurgery, Pain, swelling, Piezo surgery

Outcome Measures

Primary Outcomes (2)

• changes in pain severity

  visual analogue scale that is calibrated between (no discomfort ) and end with (very server pain ),

  to measure changes in the pain severity at 3 hours, 24 hours , 48 hours , 72 hours and 120 hours.

• Swelling size changes

  Changes in amount of swelling will be measured by measuring distance between fixed points in patient face.

  At the second and seventh days after the microsurgery, patients will be re-called for the determination of edema and swelling

Study Arms (2)

Piezo endodontic surgery

EXPERIMENTAL

The osteotomy will be applied under magnification with a surgical operating microscope (at the apical third of the root .Osteotomy will be done with the Piezosurgery touch

Procedure: Endodontic Microsurgery

Conventional endodontic surgery

ACTIVE COMPARATOR

The osteotomy will be applied under magnification with a surgical operating microscope at the apical third of the root .Osteotomy will be done with air motor high speed hand-piece and round bur with copious irrigation

Procedure: Endodontic Microsurgery

Interventions

Endodontic Microsurgery PROCEDURE

Osteotomy will be done either with air motor high speed hand-piece and round bur with copious irrigation or with Piezosurgery touch. After the soft tissue curettage and uncovering the root apex , the last 3 mm of the root apex will be resected perpendicular to the long axis of the tooth at ( 0 - 10) degree bevel , using either conventional dental hand-piece or piezotome (Piezotome Cube by ACTEON ).The resected root will be rinsed , dried and and stained with 1% methylene blue dye after which , it will be inspected carefully under high magnification, to identify possible reasons for the non surgical root canal treatment failure. Subsequently, ultrasonic apical preparation will be performed. After achieving adequate haemostasis with Epinephrine pellets. Biodentine®retrograde filling material will be placed. The flap will be re-approximated and interrupted suture using non-absorbable monofilament size 5-0 suture will be applied. Finally, Post-operative parallel Digital view.

Conventional endodontic surgery; Piezo endodontic surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-smokers .
• Teeth that are periodontally healthy.
• Age (18-65)

You may not qualify if:

• Patients with an active systematic diseases that may affect the outcome
• Medically compromised patients on long term medications.
• Patients who had received analgesics or antibiotics prior to surgery will be postponed.
• Cases where orthograde endodontic treatment is feasible
• Teeth with poor prognosis.
• Teeth with an active periodontal disease (pocket depth \> 5 mm).
• Emotionally distressed patients.

Sponsors & Collaborators

• King Abdullah University Hospital: lead
• Jordan University of Science and Technology: collaborator

Study Sites (1)

Jordan University of Science and Technology

Irbid, POBOX 3030, Jordan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Facies; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Disease Attributes

Study Officials

• Lama A Awawdeh, PhD

  Jordan University of Science and Technolgoy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lama A Awawdeh, PhD

CONTACT

+962795412954; lawawdeh@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This a randomized prospective clinical study

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: June 12, 2023
• Study Start: February 1, 2022
• Primary Completion: December 12, 2024
• Study Completion: September 1, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)