Comparison of Hyaluronidase and Dexametasone in Reduction of Postoperative Edema

NCT ID: NCT05466604

Last Updated: 2022-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2022-06-30

Brief Summary

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The present study is designed to reveal effectiveness of hyaluronidase and dexamethasone on reduction of postoperative edema, pain, trismus, and infection. For this purpose, 60 participants with symmetrical mandibular wisdom teeth enrolled the present study. All measurements and evaluations were performed before and 1, 2, 3, and 7 days later the operation.

Detailed Description

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Conditions

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Edema Pain Trismus Infection, Surgical Site

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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hyaluronidase

Group Type EXPERIMENTAL

Hyaluronidase Injection mesomedica

Intervention Type DRUG

injection of 150 IU hyaluronidase to perioperative region, submucosally.

hyaluronidase control

Group Type NO_INTERVENTION

No interventions assigned to this group

dexamethasone

Group Type EXPERIMENTAL

Dexamethasone dekort

Intervention Type DRUG

injection of 8 mg dexamethasone to perioperative region, submucosally.

dexamethasone control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hyaluronidase Injection mesomedica

injection of 150 IU hyaluronidase to perioperative region, submucosally.

Intervention Type DRUG

Dexamethasone dekort

injection of 8 mg dexamethasone to perioperative region, submucosally.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* symmetrical mandibular wisdom teeth with bone retention
* patients who are signed informed consent and acceptance of study involvement forms

Exclusion Criteria

* existence of any systemic disease
* existence of any periodical drug intake
* existence of difference in operation times of right and left impacted wisdom teeth extractions more than 5 minutes
* existence of pregnancy
* existence of breastfeeding
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Onur Koç

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Near East University

Nicosia, , Cyprus

Site Status

Hacettepe University

Ankara, Sıhhiye, Turkey (Türkiye)

Site Status

Countries

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Cyprus Turkey (Türkiye)

References

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Koc O, Er N, Karaca C, Bilginaylar K. Comparison of the effects of submucosal hyaluronidase and dexamethasone on postoperative edema, pain, trismus, and infection following impacted third molar surgery. BMC Oral Health. 2024 Aug 30;24(1):1018. doi: 10.1186/s12903-024-04729-1.

Reference Type DERIVED
PMID: 39215323 (View on PubMed)

Other Identifiers

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YDU/2019//74-921

Identifier Type: -

Identifier Source: org_study_id

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