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

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

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).

Study Overview

• Status: Unknown
• Conditions: Gingival Hemorrhage
• Intervention / Treatment: Other: No Cord impression material; Device: cord; Other: Gingitrac

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: asma m serag, lecturer; Phone Number: 01006513595; Email: sou_201085@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt, 002
    • Recruiting
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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
Active Comparator: 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.	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
Experimental: Ultrapk cord; the cord packed into the gingival sulcus around the tooth	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
Placebo Comparator: nocord; used directly in the tray	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): May 30, 2020

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 27, 2019

Study Record Updates

• Last Update Posted (Actual): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Oral Hemorrhage; Hemorrhage; Gingival Hemorrhage
• Other Study ID Numbers: 2000019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No