Mandibular AbscessPhase 4NCT06164509
Healing Potentiality of Trypsin and Alpha Chemo Trypsin in Mandibular Molars With Chronic Apical Abscess
A Phase 4 study testing Alphintern® , tablet, Amoun, Egypt in people with Mandibular Abscess, run by Ain Shams University at 1 site in Egypt.
Trial summary
assessment of healing potentiality of peri apical lesions using different doses of trypsin and alpha chemo trypsin in mandibular molars with chronic apical abscess Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mandibular Abscess
- What is being tested?
- Alphintern® , tablet, Amoun, Egypt
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2023to 20 Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: any age group.
- Both genders.
- Cases with mandibular molars with chronic apical abscess
Who cannot join
- Patients with significant comorbidities like uncontrolled diabetes mellitus, hypertension, hepatic or renal disorders.
- Immunocompromised patients.
- Patient with allergy from study medications.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ain Shams university
Cairo, Nasir City, 6619
DR. Maram Obaid, professor, 01223562609 ext. 0020, maramobeid@dent.asu.edu.eg
About this study
Official title: Healing Potentiality of Different Doses of Trypsin and Alpha Chemo Trypsin in Mandibular Molars With Chronic Apical Abscess
assessment of healing potentiality of peri apical lesions using different doses of trypsin and alpha chemo trypsin in mandibular molars with chronic apical abscess
Read the detailed description
Owing to anti-inflammatory, anti-oedematous, fibrinolytic, anti-infective, and analgesic effects, trypsin:
chymotrypsin oral combination has emerged as a promising treatment of mandibular molars with chronic apical abscess. Trypsin chymotrypsin combination always showed a significant reduction in swelling and pain postoperatively.
Study procedures:
- According to inclusion and exclusion criteria; patients will be subjected to complete history taking, general and local "dental" examinations.
- Important dental symptoms will be assessed include bleeding, pain, malocclusion, new growths, numbness or paresthesias, and chewing problems.
- General information will be reported including use of alcohol or tobacco and systemic symptoms, such as fever and weight loss.
- A thorough inspection with good illumination, a tongue blade, gloves, and a gauze pad will be performed.
- Complete or partial dentures will be removed so that underlying soft tissues can be seen.
- A head-mounted light will be used. However, because the light cannot be precisely aligned on the axis of vision, it is difficult to avoid shadowing in narrow areas.
- Better illumination results will be performed with a head-mounted convex mirror.
- The temporomandibular joint (TMJ) will be assessed by looking for jaw deviation on opening and by palpating the head of the condyle anterior to the external auditory meatus.
- Examiner then place his little fingers into the external ear canals with the pads of the fingertips lightly pushing anteriorly while patients repeatedly open widely and then close.
- Preoperative preapical X-ray and CBCT will be done.
- Cases will be randomly divided into 3 groups; Group A will receive (Alphintern®, tablet, Amoun, Egypt), Group B will receive (Limitless Allzyme Max®, tablet, Eva, Egypt) Group C will not receive medication
- Medications will be taken three times daily for 7 days postoperative, after that all cases will be reexamined regarding healing rate, adverse effect and failure rate of medical treatment.
- Randomization, allocation and concealment: It will be done using computer generated randomization sheet. Sealed opaque packages will be given to a third person (nurse) who will assign the packages to study groups. Each patient will be invited to pull out a package. According to the number inside package, cases will be allocated to either group A, B or C according to a computer- generated random list.
- Postoperative preapical X-ray will be done at the end of the root canal treatment.
- Patient will be recalled after three months for preapical X-ray assessment.
- After six months patient will be recalled for preapical X-ray and CBCT to be done.
- Conditions
- Mandibular Abscess
- Being tested
- Alphintern® , tablet, Amoun, Egypt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alphintern® , tablet, Amoun, EgyptDrug
Also called Limitless Allzyme Max®, tablet, Eva, Egypt
Medications will be taken three times daily for 7 days postoperative, after that all cases will be reexamined regarding healing rate, adverse effect and failure rate of medical treatment.
| Study group | Role | What they receive |
|---|---|---|
| Alphintern | Active comparator | Group A will receive (Alphintern® tablet, Amoun, Egypt), Receives: Drug: Alphintern® , tablet, Amoun, Egypt |
| Alzyme Max | Active comparator | Group B will receive (Limitless Allzyme Max®, tablet, Eva, Egypt) Receives: Drug: Alphintern® , tablet, Amoun, Egypt |
| Placebo | No intervention | Group C will not receive medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion size and bone Formation will be measured by cone-beam computed tomography
cone-beam computed tomography will be done Before Drug is given and after 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start20 Dec 2023 (estimated)
- Primary completion20 Sep 2024 (estimated)
- Study completion20 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mandibular AbscessStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164509
- Sponsor's protocol ID
- AinShamsUNII
- Status last verified
- Nov 2023
- First submitted
- 21 Nov 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bouillaguet S, Manoil D, Girard M, Louis J, Gaia N, Leo S, Schrenzel J, Lazarevic V. Root Microbiota in Primary and Secondary Apical Periodontitis. Front Microbiol. 2018 Oct 9;9:2374. doi: 10.3389/fmicb.2018.02374. eCollection 2018.
PubMed 30356779Oberoi SS, Dhingra C, Sharma G, Sardana D. Antibiotics in dental practice: how justified are we. Int Dent J. 2015 Feb;65(1):4-10. doi: 10.1111/idj.12146. Epub 2014 Dec 16.
PubMed 25510967
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Potentiality of Different Doses of Trypsin and Alpha Chemo Trypsin in Mandibular Molars With Chronic Apical Abscess
- ClinicalTrials.gov ID
- NCT06164509
- Acronym / sponsor ID
- AinShamsUNII
- Conditions
- Mandibular Abscess
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (estimated)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 11 Dec 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.
assessment of healing potentiality of peri apical lesions using different doses of trypsin and alpha chemo trypsin in mandibular molars with chronic apical abscess
Detailed description
Owing to anti-inflammatory, anti-oedematous, fibrinolytic, anti-infective, and analgesic effects, trypsin:
chymotrypsin oral combination has emerged as a promising treatment of mandibular molars with chronic apical abscess. Trypsin chymotrypsin combination always showed a significant reduction in swelling and pain postoperatively.
Study procedures:
- According to inclusion and exclusion criteria; patients will be subjected to complete history taking, general and local "dental" examinations.
- Important dental symptoms will be assessed include bleeding, pain, malocclusion, new growths, numbness or paresthesias, and chewing problems.
- General information will be reported including use of alcohol or tobacco and systemic symptoms, such as fever and weight loss.
- A thorough inspection with good illumination, a tongue blade, gloves, and a gauze pad will be performed.
- Complete or partial dentures will be removed so that underlying soft tissues can be seen.
- A head-mounted light will be used. However, because the light cannot be precisely aligned on the axis of vision, it is difficult to avoid shadowing in narrow areas.
- Better illumination results will be performed with a head-mounted convex mirror.
- The temporomandibular joint (TMJ) will be assessed by looking for jaw deviation on opening and by palpating the head of the condyle anterior to the external auditory meatus.
- Examiner then place his little fingers into the external ear canals with the pads of the fingertips lightly pushing anteriorly while patients repeatedly open widely and then close.
- Preoperative preapical X-ray and CBCT will be done.
- Cases will be randomly divided into 3 groups; Group A will receive (Alphintern®, tablet, Amoun, Egypt), Group B will receive (Limitless Allzyme Max®, tablet, Eva, Egypt) Group C will not receive medication
- Medications will be taken three times daily for 7 days postoperative, after that all cases will be reexamined regarding healing rate, adverse effect and failure rate of medical treatment.
- Randomization, allocation and concealment: It will be done using computer generated randomization sheet. Sealed opaque packages will be given to a third person (nurse) who will assign the packages to study groups. Each patient will be invited to pull out a package. According to the number inside package, cases will be allocated to either group A, B or C according to a computer- generated random list.
- Postoperative preapical X-ray will be done at the end of the root canal treatment.
- Patient will be recalled after three months for preapical X-ray assessment.
- After six months patient will be recalled for preapical X-ray and CBCT to be done.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alphintern | Active comparator | Drug: Alphintern® , tablet, Amoun, EgyptGroup A will receive (Alphintern® tablet, Amoun, Egypt), |
| Alzyme Max | Active comparator | Drug: Alphintern® , tablet, Amoun, EgyptGroup B will receive (Limitless Allzyme Max®, tablet, Eva, Egypt) |
| Placebo | No intervention | –Group C will not receive medication |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age: any age group.
- Both genders.
- Cases with mandibular molars with chronic apical abscess
Key exclusion criteria (3 listed)
- Patients with significant comorbidities like uncontrolled diabetes mellitus, hypertension, hepatic or renal disorders.
- Immunocompromised patients.
- Patient with allergy from study medications.
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 |
|---|---|---|
| Alphintern® , tablet, Amoun, EgyptAlso: Limitless Allzyme Max®, tablet, Eva, EgyptMedications will be taken three times daily for 7 days postoperative, after that all cases will be reexamined regarding healing rate, adverse effect and failure rate of medical treatment. | Drug | Alphintern, Alzyme Max |
Primary outcome
Lesion size and bone Formation will be measured by cone-beam computed tomography
Time frame: 6 months
cone-beam computed tomography will be done Before Drug is given and after 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Background: PubMed 30356779Bouillaguet S, Manoil D, Girard M, Louis J, Gaia N, Leo S, Schrenzel J, Lazarevic V. Root Microbiota in Primary and Secondary Apical Periodontitis. Front Microbiol. 2018 Oct 9;9:2374. doi: 10.3389/fmicb.2018.02374. eCollection 2018.
- Background: PubMed 25510967Oberoi SS, Dhingra C, Sharma G, Sardana D. Antibiotics in dental practice: how justified are we. Int Dent J. 2015 Feb;65(1):4-10. doi: 10.1111/idj.12146. Epub 2014 Dec 16.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alphintern® , tablet, Amoun, Egypt in people with Mandibular Abscess, run by Ain Shams University at 1 site in Egypt.
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 3 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: status not confirmed, as of the sponsor's last update on 11 Dec 2023. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ghassan Salameh, Master (01553569580 ext. 0020, ghassan_salameh97@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion size and bone Formation will be measured by cone-beam computed tomography (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06164509, which also lists 2 linked publications.
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 11 Dec 2023.