Pain PostoperativeNCT05898035
Postoperative Symptoms Following Endodontic Microsurgery
A study testing Endodontic Microsurgery in people with Pain Postoperative and Swelling Lips & Face, run by King Abdullah University Hospital at 1 site in Jordan.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Postoperative, Swelling Lips & Face
- What is being tested?
- Endodontic Microsurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJordan
- Study dates
- 1 Feb 2022to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-smokers .
- Teeth that are periodontally healthy.
- Age (18-65)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site, 1 recruiting
- Recruiting
Jordan University of Science and Technology
Irbid, POBOX 3030
Lama A Awawdeh, 0795412954, lawawdeh@hotmail.com
About this study
Official title: Postoperative Symptoms Following Endodontic Microsurgery Performed by Piezoelectric Osteotomy Versus Conventional Osteotomy: A Randomized Clinical 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.
Read the detailed description
This randomized prospective clinical study will be conducted at the postgraduate clinics, Department of Conservative Dentistry, at Jordan University of Science and Technology.
Ethical approval will be sought from the JUST Institutional ethics and human Research Board (IRB) committee.
Sample size and randomization A total of 44 adult patients will be recruited for this clinical trial. Participants will be randomly allocated to one of the two treatment modalities. Randomization will be carried out by sealed envelope online software.
For the observational part of the study, no randomization or blinding will be applied. Patients will be treated free of charge and their travel expenses will be compensated for all follow up visits.
Preoperative management :
Clinical and radiographic assessment :
- The patient demographic information, chief complaint and history of the chief complaint, medical and dental history will be registered. A thorough extra-oral and intra-oral examination will be undertaken (an existing swelling , sinus tracts, quality of coronal restoration margins and its history, occlusal relations, gingival biotype , any gingival recession and periodontal assessment ) will be registered .
Percussion and palpating tests will be applied. Pre-operative parallel Digital view will be obtained using film holder showing the entire lesion and at least 2 mm beyond it. Limited view cone beam computed tomography scan of the diseased tooth will be obtained for each patient preoperatively (SFV).
Root length and axis, Lesion size and features, bone crest level and any radiographic abnormality will be interpreted and registered.
All patients will receive periodontal scaling a week or two before the surgery. Surgical procedure Prior to surgery , patients will be asked to rinse their mouth with chlorhexidine 0.12% . After which, local anesthesia containing epinephrine will be given. The surgical flap design and procedure will be selected as per case deem , and the flap will be elevated gently and retracted.
The Root apex will be located and osteotomy will be applied. 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 (Gingi-Pak , California state , USA),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 will be obtained using film holder showing the entire lesion and at least 2 mm beyond it.
Post-operative management :
Immediately after the microsurgery the patients will be asked to apply cold ice packs on the surgical site for 20 mins at the clinic, during this time the post-operative instructions will be given .
- Conditions
- Pain Postoperative, Swelling Lips & Face
- Being tested
- Endodontic Microsurgery
- Keywords
- Microsurgery, Pain, swelling, Piezo surgery
- Medical subject headings
- Pain, Postoperative, Facies, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endodontic MicrosurgeryProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Endodontic Microsurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in pain severity
visual analogue scale that is calibrated between (no discomfort ) and end with (very server pain ),
Measured: 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.
Measured: At the second and seventh days after the microsurgery, patients will be re-called for the determination of edema and swelling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Feb 2022
- Primary completion12 Dec 2024
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This a randomized prospective clinical study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Principal investigator, Lama Awawdeh, King Abdullah University Hospital
- Investigators
- Lama A Awawdeh, PhD, Principal investigator, Jordan University of Science and Technolgoy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898035
- Sponsor's protocol ID
- KingAbdullahUH
- Status last verified
- Apr 2025
- First submitted
- 2 Mar 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Symptoms Following Endodontic Microsurgery Performed by Piezoelectric Osteotomy Versus Conventional Osteotomy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05898035
- Acronym / sponsor ID
- KingAbdullahUH
- Conditions
- Pain Postoperative, Swelling Lips & Face
- Keywords
- Microsurgery, Pain, swelling, Piezo surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- Sep 2025 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized prospective clinical study will be conducted at the postgraduate clinics, Department of Conservative Dentistry, at Jordan University of Science and Technology.
Ethical approval will be sought from the JUST Institutional ethics and human Research Board (IRB) committee.
Sample size and randomization A total of 44 adult patients will be recruited for this clinical trial. Participants will be randomly allocated to one of the two treatment modalities. Randomization will be carried out by sealed envelope online software.
For the observational part of the study, no randomization or blinding will be applied. Patients will be treated free of charge and their travel expenses will be compensated for all follow up visits.
Preoperative management :
Clinical and radiographic assessment :
- The patient demographic information, chief complaint and history of the chief complaint, medical and dental history will be registered. A thorough extra-oral and intra-oral examination will be undertaken (an existing swelling , sinus tracts, quality of coronal restoration margins and its history, occlusal relations, gingival biotype , any gingival recession and periodontal assessment ) will be registered .
Percussion and palpating tests will be applied. Pre-operative parallel Digital view will be obtained using film holder showing the entire lesion and at least 2 mm beyond it. Limited view cone beam computed tomography scan of the diseased tooth will be obtained for each patient preoperatively (SFV).
Root length and axis, Lesion size and features, bone crest level and any radiographic abnormality will be interpreted and registered.
All patients will receive periodontal scaling a week or two before the surgery. Surgical procedure Prior to surgery , patients will be asked to rinse their mouth with chlorhexidine 0.12% . After which, local anesthesia containing epinephrine will be given. The surgical flap design and procedure will be selected as per case deem , and the flap will be elevated gently and retracted.
The Root apex will be located and osteotomy will be applied. 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 (Gingi-Pak , California state , USA),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 will be obtained using film holder showing the entire lesion and at least 2 mm beyond it.
Post-operative management :
Immediately after the microsurgery the patients will be asked to apply cold ice packs on the surgical site for 20 mins at the clinic, during this time the post-operative instructions will be given .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This a randomized prospective clinical study
| Arm | Type | Receives |
|---|---|---|
| Piezo endodontic surgery | Experimental | Procedure: Endodontic MicrosurgeryThe 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 |
| Conventional endodontic surgery | Active comparator | Procedure: Endodontic MicrosurgeryThe 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-smokers .
- Teeth that are periodontally healthy.
- Age (18-65)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endodontic MicrosurgeryOsteotomy 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. | Procedure or surgery | Conventional endodontic surgery, Piezo endodontic surgery |
Primary outcome
changes in pain severity
Time frame: to measure changes in the pain severity at 3 hours, 24 hours , 48 hours , 72 hours and 120 hours.
visual analogue scale that is calibrated between (no discomfort ) and end with (very server pain ),
Swelling size changes
Time frame: At the second and seventh days after the microsurgery, patients will be re-called for the determination of edema and swelling
Changes in amount of swelling will be measured by measuring distance between fixed points in patient face.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lama A Awawdeh, PhD principal investigator
Jordan University of Science and Technolgoy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endodontic Microsurgery in people with Pain Postoperative and Swelling Lips & Face, run by King Abdullah University Hospital at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lama A Awawdeh, PhD (+962795412954, lawawdeh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in pain severity (time frame: to measure changes in the pain severity at 3 hours, 24 hours , 48 hours , 72 hours and 120 hours.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.