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
1 other identifier
interventional
40
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2019
CompletedFirst Submitted
Initial submission to the registry
March 20, 2019
CompletedFirst Posted
Study publicly available on registry
March 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2020
CompletedJanuary 2, 2020
December 1, 2019
1 year
March 20, 2019
December 28, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Horizontal gingival displacement
from baseline to 24 hours
Gingival index
at baseline ,after 1 day and after seven days
Pocket depth
at baseline, after 1 day and after seven days
Plaque index
at baseline, after 1 day and after seven days
Study Arms (4)
Gingitrac
ACTIVE COMPARATORThe 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
ACTIVE COMPARATORThe 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
EXPERIMENTALthe cord packed into the gingival sulcus around the tooth
nocord
PLACEBO COMPARATORused directly in the tray
Interventions
the no cord self- retracting impression material placed directly in the tray
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Age \<18 years.
- Gingival and periodontal disease.
- Uncontrolled diabetes, hypertension, hyperthyroidism and other cardiovascular disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, 002, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- unkown the group during recording the results of outcome
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of periodontology, principal investigator
Study Record Dates
First Submitted
March 20, 2019
First Posted
March 27, 2019
Study Start
February 1, 2019
Primary Completion
February 1, 2020
Study Completion
May 30, 2020
Last Updated
January 2, 2020
Record last verified: 2019-12