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

Not Applicable

• Conditions: Gingival Hemorrhage
• Interventions: Other: No Cord impression material; Device: cord; Other: Gingitrac

• Registration Number: NCT03892109
• Lead Sponsor: Cairo University

Brief 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).

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 Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-03-20
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-27
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-28
• Last Update Posted: 2020-01-02
• Primary Completion: 2020-02-01
• Study Completion: 2020-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gingitrac	No Cord impression material	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.
Gingitrac	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.
Ultrapk cord	cord	the cord packed into the gingival sulcus around the tooth
traxodent	No Cord impression material	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.
Ultrapk cord	No Cord impression material	the cord packed into the gingival sulcus around the tooth
Ultrapk cord	Gingitrac	the cord packed into the gingival sulcus around the tooth
nocord	No Cord impression material	used directly in the tray
nocord	cord	used directly in the tray
traxodent	Gingitrac	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.
nocord	Gingitrac	used directly in the tray
Gingitrac	cord	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.
traxodent	cord	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.

Primary Outcome Measures

Name	Time	Method
Time of placement	the time recorded in seconds (from 1 second to 2 minutes)	time taken for placement of each retraction system was recorded during application
Hemorrhage score	from base line to 1 day	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)

Secondary Outcome Measures

Name	Time	Method
Pocket depth	at baseline, after 1 day and after seven days	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.
Gingival index	at baseline ,after 1 day and after seven days	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).
Horizontal gingival displacement	from baseline to 24 hours	The horizontal displacement was measured on polyether impressions made before the retraction and after retraction using steroscope.
Plaque index	at baseline, after 1 day and after seven days	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).

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt