Postoperative Symptoms Following Endodontic Microsurgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKing Abdullah University Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Non-smokers .
Teeth that are periodontally healthy.
Age (18-65)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Endodontic Microsurgery
Procedure/SurgeryOsteotomy 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Piezo endodontic surgeryExperimental treatment 1 intervention
Group B: Conventional endodontic surgeryActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
changes in pain severity
visual analogue scale that is calibrated between (no discomfort ) and end with (very server pain ),
Time frame
to measure changes in the pain severity at 3 hours, 24 hours , 48 hours , 72 hours and 120 hours.2
Swelling size changes
Changes in amount of swelling will be measured by measuring distance between fixed points in patient face.
Time frame
At the second and seventh days after the microsurgery, patients will be re-called for the determination of edema and swellingSponsors and contacts
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King Abdullah University Hospital
Lead sponsor
Jordan University of Science and Technology
Collaborator
Source ClinicalTrials.gov