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Evaluation of Different Gingival Retraction Systems on Gingival Displacement and Periodontal Health (retraction)

Cairo University (CU) logo

Cairo University (CU)

Status

Unknown

Conditions

Gingival Hemorrhage

Treatments

Other: No Cord impression material
Other: Gingitrac
Device: cord

Study type

Interventional

Funder types

Other

Identifiers

NCT03892109
2000019

Details and patient eligibility

About

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).

Full description

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 4 patient groups, including a placebo group

Gingitrac
Active Comparator group
Description:
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.
Treatment:
Other: Gingitrac
Other: No Cord impression material
Device: cord
traxodent
Active Comparator group
Description:
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.
Treatment:
Other: Gingitrac
Other: No Cord impression material
Device: cord
Ultrapk cord
Experimental group
Description:
the cord packed into the gingival sulcus around the tooth
Treatment:
Other: Gingitrac
Other: No Cord impression material
Device: cord
nocord
Placebo Comparator group
Description:
used directly in the tray
Treatment:
Other: Gingitrac
Other: No Cord impression material
Device: cord

Trial contacts and locations

1

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Central trial contact

asma m serag, lecturer

Data sourced from clinicaltrials.gov

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