Evaluation of the Effect of Systemic Proteolytic Enzyme Therapy.

Sponsor

University of Baghdad (Other)

Overall Status

Recruiting

CT.gov ID

NCT05681312

Collaborator

(none)

Enrollment

Location

Arms

8.9

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the postoperative pain between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day.
To compare the postoperative swelling (edema) between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day.
To compare the degree of trismus between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day.
Measure patients' perceptions of changes in their quality of life in the postoperative period and compare it between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain	Drug: systemic proteolytic enzyme (Tibrolin) Drug: Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mg	Phase 3

Detailed Description

Evaluation of the effect of systemic proteolytic enzyme therapy on postoperative inflammatory response and quality of life after surgical extraction of impacted mandibular third molar.

The aim of this study is to evaluate the effect of systemic enzyme therapy(TibrolinTM) on the postoperative inflammatory response and the quality of life after surgical removal of impacted third molar. The study is designed and was implemented as a randomized controlled clinical study guided by Consolidated Standards of Reporting Trials (CONSORT) guidelines . Patients were randomly allocated to two groups (25patients per group). Group A included administration of SET after surgery and continued for 5 days post-surgery; Group B, a control group that would not receive the systemic enzyme therapy . The predictor variable was The use of systemic proteolytic enzyme (Tibrolin) or not .The primary outcome variables were pain and swelling , trismus,quality of life measured on 1st day (day of surgery), third day, and 7th after surgery.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Tibrolin combination of (Trypsin 48 mg, Bromelain 90 mgand a bioflavonoid (Rutoside 100 mg) .one by one for five dayTibrolin combination of (Trypsin 48 mg, Bromelain 90 mgand a bioflavonoid (Rutoside 100 mg) .one by one for five day

Masking:

Single (Participant)

Masking Description:

metronidazol 500 mg 1bythree amoxicillin 500 mg 1by three doulprane 1000 mg one by one

Primary Purpose:

Treatment

Official Title:

Evaluation of the Effect of Systemic Proteolytic Enzyme Therapy After Surgical Extraction of Impacted Mandibular Third Molar.

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Mar 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: systemic proteolytic enzyme Tibrolin combination of (Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg) one by one for five day	Drug: systemic proteolytic enzyme (Tibrolin) Tibrolin is a fixed dose combination of(Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg) Other Names: tibrolin
Placebo Comparator: amoxicillin, metronidazol, doliprane amoxicillin 500 mg one by three metronidazol 500 mg one by three doulprane 1000 mg one by one	Drug: Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mg Amoxicillin is given with metronidazole 500mg 13' Doliprane 1000mg is given 11

Arm

Intervention/Treatment

Active Comparator: systemic proteolytic enzyme

Tibrolin combination of (Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg) one by one for five day

Drug: systemic proteolytic enzyme (Tibrolin)

Tibrolin is a fixed dose combination of(Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg)

Other Names:

tibrolin

Placebo Comparator: amoxicillin, metronidazol, doliprane

amoxicillin 500 mg one by three metronidazol 500 mg one by three doulprane 1000 mg one by one

Drug: Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mg

Amoxicillin is given with metronidazole 500mg 1*3' Doliprane 1000mg is given 1*1

Outcome Measures

Primary Outcome Measures

Pain after surgery [7 Days]
pain will be measured on pain rating scale form 0 to 10
Facial swelling [7 Days]
swelling will be determined by distance between 3 points
Trismus [7 Days]
the degree of trismus will be measured by maximum mouth opening

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Healthy patients over 18 years old of either gender.
Patients who have impacted mandibular third molar.
Ability to tolerate surgical procedure.
Pell and Gregory's classification (Class I and class II, position A and B).

Exclusion Criteria:

Patients with uncontrolled systemic diseases.
Patients with history of chemotherapy or radiotherapy therapy to the head and neck region.
Acute infection at the surgical site at time of operation.
The presence of cysts or tumors associated with the impacted teeth.
Pell and Gregory's classification (class III Position C)