Evaluation of Different Gingival Retraction Systems on Gingival Displacement and Periodontal Health

NCT ID: NCT03892109

Last Updated: 2020-01-02

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-05-30

Brief Summary

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The interrelationship of restorative dentistry and periodontics is a dynamic one. The interactions between restorative dentistry and periodontal health have been well-documented both clinically and histologically.

The interplay between periodontics and restorative dentistry is present at many fronts, including location of restorative margins, alloy sensitivity, crown contours, and response of the gingival tissues to restorative preparations.

Periodontal tissues form the foundation for proper esthetics, function, and comfort of the dentition, as well as the periodontal health at the restorative gingival interface consider as prerequisite for successful outcome.

Success of fixed prosthodontics restorations is largely dependent upon the long term health and stability of the surrounding periodontal structures.

The purpose of the present study was to evaluate the clinical efficacy of 4 new gingival retraction systems; traxodent, Gingitrac, Nocord, and cord , on the basis of the time taken for placement, hemorrhage control ,the amount of horizontal gingival displacement and periodontal parameter (PI, GI, CAL and PD).

Detailed Description

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The interplay between periodontics and restorative dentistry is present at many fronts, including location of restorative margins, alloy sensitivity, crown contours, and response of the gingival tissues to restorative preparations.

And from fixed prothodontic point of view there are several factors affect the success and durability of restorations. In general, the type of impression making, setting accuracy, material flow, temperature, humidity, mixing, disinfection and pouring time have effects on the final accuracy of the indirect restorations. Supra-gingival margins are effective in periodontal health maintenance, but do not provide optimal aesthetics.

The primary factor in defective record of marginal details is due to the inefficacy of the gingival displacement technique.

Traditionally, procedures for soft-tissue management and isolation are classified into three main approaches: Mechanical, chemical or surgical.

material and method:-

40 subjects were selected requiring fixed prosthesis according to inclusion and exclusion criteria.

The 4 gingival retraction systems were used on the prepared abutments randomly. The time taken for placement of each retraction system was recorded.

Hemorrhage score will be recoreded. The horizontal retraction was measured on polyether impressions made before the retraction and after retraction using stereoscope.

The periodontal parameter (PI, GI, CAL and PD) will be recorded pre-operative, 1 day post-operative and 7 days post-operative.

Conditions

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Gingival Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
unkown the group during recording the results of outcome

Study Groups

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Gingitrac

The gingitrac cartridge was attached to the automixing gun and then the mixing syringe with intraoral tip was placed into the gingival sulcus and gingival retraction material was applied all around the selected abutment. After injecting the retraction material ,the corresponding comprecap was placed on to the abutment to push the material deep into the gingival sulcus. After 4 min, the comprecap with the set retraction material attached to it was removed from the patient mouth.

Group Type ACTIVE_COMPARATOR

No Cord impression material

Intervention Type OTHER

the no cord self- retracting impression material placed directly in the tray

cord

Intervention Type DEVICE

Cords were placed in the gingival sulcus with use of a cord packer, and left in situ for 10 min before making the impression. None of the retraction cords were immersed in any solution or medicaments prior to insertion.

Gingitrac

Intervention Type OTHER

packed into the sulcus

traxodent

The traxodent cartridge was attached to the automixing gun and then the mixing syringe with intraoral tip was placed into the gingival sulcus and gingival retraction material was applied all around the tooth. After injecting the retraction material ,the corresponding comprecap was placed on to the abutment to push the material deep into the gingival sulcus. After 4 min, the comprecap with the set retraction material attached to it was removed from the patient mouth.

Group Type ACTIVE_COMPARATOR

No Cord impression material

Intervention Type OTHER

the no cord self- retracting impression material placed directly in the tray

cord

Intervention Type DEVICE

Cords were placed in the gingival sulcus with use of a cord packer, and left in situ for 10 min before making the impression. None of the retraction cords were immersed in any solution or medicaments prior to insertion.

Gingitrac

Intervention Type OTHER

packed into the sulcus

Ultrapk cord

the cord packed into the gingival sulcus around the tooth

Group Type EXPERIMENTAL

No Cord impression material

Intervention Type OTHER

the no cord self- retracting impression material placed directly in the tray

cord

Intervention Type DEVICE

Cords were placed in the gingival sulcus with use of a cord packer, and left in situ for 10 min before making the impression. None of the retraction cords were immersed in any solution or medicaments prior to insertion.

Gingitrac

Intervention Type OTHER

packed into the sulcus

nocord

used directly in the tray

Group Type PLACEBO_COMPARATOR

No Cord impression material

Intervention Type OTHER

the no cord self- retracting impression material placed directly in the tray

cord

Intervention Type DEVICE

Cords were placed in the gingival sulcus with use of a cord packer, and left in situ for 10 min before making the impression. None of the retraction cords were immersed in any solution or medicaments prior to insertion.

Gingitrac

Intervention Type OTHER

packed into the sulcus

Interventions

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No Cord impression material

the no cord self- retracting impression material placed directly in the tray

Intervention Type OTHER

cord

Cords were placed in the gingival sulcus with use of a cord packer, and left in situ for 10 min before making the impression. None of the retraction cords were immersed in any solution or medicaments prior to insertion.

Intervention Type DEVICE

Gingitrac

packed into the sulcus

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. forty patients whose ages more than 18 years were selected requiring fixed prosthesis with minimum of two abutments.
2. Clinically and radiographically healthy gingiva and periodontium around the abutments.
3. Abutment teeth of normal size and contour (no developmental anomaly or regressive age changes).

Exclusion Criteria

1. Age \<18 years.
2. Gingival and periodontal disease.
3. Uncontrolled diabetes, hypertension, hyperthyroidism and other cardiovascular disorders.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Asma Serag

Lecturer of periodontology, principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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asma m serag, lecturer

Role: CONTACT

01006513595

Other Identifiers

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2000019

Identifier Type: -

Identifier Source: org_study_id

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