Single Puncture Arthrocentesis vs Double Puncture Arthrocentesis

NCT ID: NCT04367259

Last Updated: 2020-04-29

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

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-12-01

Brief Summary

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The aim of the present study was to compare the treatment efficacy of single puncture arthrocentesis (SPA) and double puncture arthrocentesis (DPA) techniques in Temporomandibular joint (TMJ) disc displacement without reduction (DDwoR).

Detailed Description

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Study sample consisted of 36 patients with DDwoR. 18 patients received SPA procedure and included in SPA group. The other 18 patients received DPA procedure and included in DPA group.

Double puncture arthrocentesis technique:

Posterior puncture method was used as described by Alkan and Etoz. for DPA. A straight line was drawn with a marker pen along the skin from the middle portion of the auricular tragus to the lateral chantus. The first puncture point was marked 10 mm anterior and 2 mm inferior to the tragus and the second 7 mm anterior and 2 mm inferior to the tragus. After local anesthesia, upper joint cavity was irrigated with 200 mL of Lactated Ringer's (RL) solution by inserting two 21- gauge needle. At the end of the procedure, after withdrawn of one of the needles, 1 mL of sodium hyaluronate (SH) was injected into the upper TMJ compartment through the other needle.

Single Puncture Arthrocentesis Technique:

SPA was performed with one needle (SPA Type-1 according to Senturk and Cambazoglu). The first reference point in DPA was used as the needle entry point fort he SPA. With this technique, the inflow and outflow of solution were provided through the same cannula and lumen of one 21-gauge needle as described by Guarda-Nardini et al. The joint was irrigated with 200 mL of RL solution under high pressure. At the end of the procedure1 mL of SH was injected through the needle.

Conditions

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Arthrocentesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single puncture arthrocentesis (SPA) group

Patients presenting temporomandibular joint disc displacement without reduction (DDwoR) treated with single puncture arthrocentesis

Group Type ACTIVE_COMPARATOR

TMJ Arthrocentesis

Intervention Type PROCEDURE

Temporomandibular joint arthrocentesis

Double puncture arthrocentesis (DPA) group

Patients presenting temporomandibular joint disc displacement without reduction (DDwoR) treated with double puncture arthrocentesis

Group Type ACTIVE_COMPARATOR

TMJ Arthrocentesis

Intervention Type PROCEDURE

Temporomandibular joint arthrocentesis

Interventions

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TMJ Arthrocentesis

Temporomandibular joint arthrocentesis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of Temporomandibular joint (TMJ) disc displacement without reduction.
* Restricted mouth opening

Exclusion Criteria

* History of systemic disease effecting TMJ.
* History of previous TMJ surgery
Minimum Eligible Age

21 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Erzincan University

OTHER

Sponsor Role lead

Responsible Party

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Fatih TASKESEN

Head of Dept. Oral and Maxillofacial Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatih TASKESEN

Role: STUDY_CHAIR

Erzincan Binali Yildirim University Faculty of Dentistry

Locations

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Erzincan Ağiz Ve Diş Sağlığı Egt Araş Hastanesi

Erzincan, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Bayramoglu Z, Tozoglu S. Comparison of single- and double-puncture arthrocentesis for the treatment of temporomandibular joint disorders: A six-month, prospective study. Cranio. 2021 Mar;39(2):151-156. doi: 10.1080/08869634.2019.1603796. Epub 2019 Apr 25.

Reference Type RESULT
PMID: 31021311 (View on PubMed)

Senturk MF, Yazici T, Findik Y, Baykul T. Intraoperative comparison of single- and double-puncture techniques in temporomandibular joint arthrocentesis. Int J Oral Maxillofac Surg. 2018 Aug;47(8):1060-1064. doi: 10.1016/j.ijom.2018.03.029. Epub 2018 May 1.

Reference Type RESULT
PMID: 29685386 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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135163

Identifier Type: -

Identifier Source: org_study_id

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