Healing Potentiality of Trypsin and Alpha Chemo Trypsin in Mandibular Molars With Chronic Apical Abscess

December 7, 2023 updated by: Ain Shams University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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:

  1. According to inclusion and exclusion criteria; patients will be subjected to complete history taking, general and local "dental" examinations.
  2. Important dental symptoms will be assessed include bleeding, pain, malocclusion, new growths, numbness or paresthesias, and chewing problems.
  3. General information will be reported including use of alcohol or tobacco and systemic symptoms, such as fever and weight loss.
  4. A thorough inspection with good illumination, a tongue blade, gloves, and a gauze pad will be performed.
  5. Complete or partial dentures will be removed so that underlying soft tissues can be seen.
  6. 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.
  7. Better illumination results will be performed with a head-mounted convex mirror.
  8. 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.
  9. 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.
  10. Preoperative preapical X-ray and CBCT will be done.
  11. 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
  12. 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.
  13. 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.
  14. Postoperative preapical X-ray will be done at the end of the root canal treatment.
  15. Patient will be recalled after three months for preapical X-ray assessment.
  16. After six months patient will be recalled for preapical X-ray and CBCT to be done.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Nasir City
      • Cairo, Nasir City, Egypt, 6619

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age: any age group.
  2. Both genders.
  3. Cases with mandibular molars with chronic apical abscess

Exclusion Criteria:

  1. Patients with significant comorbidities like uncontrolled diabetes mellitus, hypertension, hepatic or renal disorders.
  2. Immunocompromised patients.
  3. Patient with allergy from study medications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Alphintern
Group A will receive (Alphintern® tablet, Amoun, Egypt),
Drug: Alphintern® , tablet, Amoun, 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.
Other Names:
  • Limitless Allzyme Max®, tablet, Eva, Egypt
Active Comparator: Alzyme Max
Group B will receive (Limitless Allzyme Max®, tablet, Eva, Egypt)
Drug: Alphintern® , tablet, Amoun, 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.
Other Names:
  • Limitless Allzyme Max®, tablet, Eva, Egypt
No Intervention: Placebo
Group C will not receive medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 20, 2023

Primary Completion (Estimated)

September 20, 2024

Study Completion (Estimated)

October 20, 2025

Study Registration Dates

First Submitted

November 21, 2023

First Submitted That Met QC Criteria

December 7, 2023

First Posted (Estimated)

December 11, 2023

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AinShamsUNII

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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