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

Primary Purpose

Gingival Hemorrhage

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
No Cord impression material
cord
Gingitrac
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Hemorrhage

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Placebo Comparator

Arm Label

Gingitrac

traxodent

Ultrapk cord

nocord

Arm 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.

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.

the cord packed into the gingival sulcus around the tooth

used directly in the tray

Outcomes

Primary Outcome Measures

Time of placement
time taken for placement of each retraction system was recorded during application
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)

Secondary Outcome Measures

Horizontal gingival displacement
The horizontal displacement was measured on polyether impressions made before the retraction and after retraction using steroscope.
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).
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.
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).

Full Information

First Posted
March 20, 2019
Last Updated
December 28, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03892109
Brief Title
Evaluation of Different Gingival Retraction Systems on Gingival Displacement and Periodontal Health
Acronym
retraction
Official Title
Clinical Comparative Evaluation of Different Retraction Systems in Gingival Displacement and Their Influence on Periodontal Health
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
May 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized
Masking
Outcomes Assessor
Masking Description
unkown the group during recording the results of outcome
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gingitrac
Arm Type
Active Comparator
Arm 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.
Arm Title
traxodent
Arm Type
Active Comparator
Arm 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.
Arm Title
Ultrapk cord
Arm Type
Experimental
Arm Description
the cord packed into the gingival sulcus around the tooth
Arm Title
nocord
Arm Type
Placebo Comparator
Arm Description
used directly in the tray
Intervention Type
Other
Intervention Name(s)
No Cord impression material
Intervention Description
the no cord self- retracting impression material placed directly in the tray
Intervention Type
Device
Intervention Name(s)
cord
Intervention Description
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
Other
Intervention Name(s)
Gingitrac
Intervention Description
packed into the sulcus
Primary Outcome Measure Information:
Title
Time of placement
Description
time taken for placement of each retraction system was recorded during application
Time Frame
the time recorded in seconds (from 1 second to 2 minutes)
Title
Hemorrhage score
Description
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)
Time Frame
from base line to 1 day
Secondary Outcome Measure Information:
Title
Horizontal gingival displacement
Description
The horizontal displacement was measured on polyether impressions made before the retraction and after retraction using steroscope.
Time Frame
from baseline to 24 hours
Title
Gingival index
Description
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).
Time Frame
at baseline ,after 1 day and after seven days
Title
Pocket depth
Description
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.
Time Frame
at baseline, after 1 day and after seven days
Title
Plaque index
Description
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).
Time Frame
at baseline, after 1 day and after seven days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: forty patients whose ages more than 18 years were selected requiring fixed prosthesis with minimum of two abutments. Clinically and radiographically healthy gingiva and periodontium around the abutments. Abutment teeth of normal size and contour (no developmental anomaly or regressive age changes). Exclusion Criteria: Age <18 years. Gingival and periodontal disease. Uncontrolled diabetes, hypertension, hyperthyroidism and other cardiovascular disorders.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
asma m serag, lecturer
Phone
01006513595
Email
sou_201085@yahoo.com
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
002
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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