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

Gingival Hemorrhage Clinical Trial

— retraction  

Official title:

Clinical Comparative Evaluation of Different Retraction Systems in Gingival Displacement and Their Influence on Periodontal Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03892109
• Other study ID #: 2000019
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: May 30, 2020

Study information

• Verified date: December 2019
• Source: Cairo University
• Contact: asma m serag, lecturer
• Phone: 01006513595
• Email: sou_201085[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 30, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Hemorrhage
• Hemorrhage

Intervention

Other:
• No Cord impression material
the no cord self- retracting impression material placed directly in the tray

Device:
• 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.

Other:
• Gingitrac
packed into the sulcus

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of placement	time taken for placement of each retraction system was recorded during application	the time recorded in seconds (from 1 second to 2 minutes)
Primary	Hemorrhage score	the amount of bleedingbleeding on probing scoring as 0, 1, and 2 (0 - no bleeding, 1 - bleeding controlled within 1 minute, bleeding, 2 - bleeding not controlled within 1 minute)	from base line to 1 day
Secondary	Horizontal gingival displacement	The horizontal displacement was measured on polyether impressions made before the retraction and after retraction using steroscope.	from baseline to 24 hours
Secondary	Gingival index	according to gingival index, scored as 0,1,2 and 3( 0 = no inflamation and no gingival bleeding, 1= mild redness of the gingiva, no bleeding, 2=moderate inflammation and redness of the gingiva, edema and bleeding,3= marked redness, edema, ulceration and severe bleeding).	at baseline ,after 1 day and after seven days
Secondary	Pocket depth	according to pocket depth The probe was held with a light grasp and pointed towards the apex buccally while being parallel to the long axis of the tooth. Each measurement was rounded to the lowest whole millimetre.; according to pocket depth The probe was held with a light grasp and pointed towards the apex buccally while being parallel to the long axis of the tooth. Each measurement was rounded to the lowest whole millimetre.	at baseline, after 1 day and after seven days
Secondary	Plaque index	according to the plaque index, plaque index scoring as 0, 1, 2, and 3 (0 - no plaque and 1 - a film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or using the probe on the tooth surface, 2 - moderate accumulation of soft deposits within the gingival pocket or the tooth and gingival margin which can be seen with the naked eye, and 3 - abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin).	at baseline, after 1 day and after seven days