The Efficacy of Different Gingival Displacement Methods Before Definitive Digital Impression

November 10, 2023 updated by: Mohamed Elashry, Alexandria University

The Efficacy of Different Gingival Displacement Methods Before Definitive Digital Impression: A Randomized Controlled Clinical Trial

This study aims to evaluate and compare the efficacy of four methods in achieving vertical and horizontal gingival tissue displacement to be captured by optical digital impression. Moreover, the effect of the gingival displacement methods on the periodontal tissues around the final restoration will be assessed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Faculty of dentistry, Alexandria university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients having normal occlusion.
  • Good oral hygiene with no signs of periapical pathology or periodontal disease (plaque index score ≤10).
  • Clinically and radiographically healthy gingiva and periodontium around the abutments with no evidence of attachment loss.
  • Thick gingival biotype (determination using color coded probe).
  • Patient having natural teeth as opposing dentition.
  • Gingival sulcus of the abutment teeth (≤ 3mm).
  • Adequate abutment tooth length for retention without deep subgingival extension (not more than 0.5mm)

Exclusion Criteria:

  • Pregnancy, which prevents the use of diagnostic x-rays.
  • Parafunctional habits.
  • Mobility of abutment teeth.
  • Gingival Recession
  • Patient presenting allergy to materials being used.
  • Smoking.
  • Medical history that could affect their periodontal condition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Laser troughing
Device: Laser troughing
Laser troughing will be carried out by passing laser optic fiber in contact mode along the gingival sulcus. Laser energy will be delivered with a wavelength of 980nm and power of 0.8W, in continuous mode. Laser tip will be inserted 1mm into the gingival sulcus, to facilitate an accurate recording of finish line
Experimental: Retraction cord and astringent
Other: Retraction cord and astringent
Partial isolation of the tooth with cotton rolls and saliva ejector will be performed. Appropriate size of retraction cord will be soaked in astringent for 5 mins. Then packing of the cord will be started from the mesial interproximal area by gently packing into the sulcus with the gingival cord packer instrument using the single cord technique. Retraction cord will be kept in place for 5 minutes. Cord will be removed immediately before the start of the intraoral scan
Experimental: Cordless retraction paste with astringent
Other: Cordless retraction paste with astringent
The cordless paste with astringent will be injected gently into the sulcus, leaning on the tooth at the point of the cervical limit and not on the gingiva, the cannula will remain parallel to the axis of the tooth to exert optimal pressure. Then it will removed after 5 mins with copiously irrigated water until no traces of the materials left.
Active Comparator: Cordless retraction paste without astringent
Other: Cordless retraction paste without astringent
The cordless paste without astringent 10 will be injected into the sulcus of the gingiva. The suitable size of Comprecap will be held on the abutment to push the material deep into the sulcus of the gingiva, and the participants will be informed to bite over it for a period of 3 to 5 minutes. After 5 minutes, the comprecap with the set retraction material attached to it, will be removed from the patient mouth.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Horizontal displacement measurement
Time Frame: up to one month
All measurements were obtained from the definitive digital impression by using dental intraoral scanner software. Horizontal displacement was measured as the distance from the most prominent point of the crest of the marginal gingiva to the finish line in the same crowns section (in the same plane).
up to one month
Vertical Displacement measurement
Time Frame: up to one month
All measurements were obtained from the definitive digital impression by using dental intraoral scanner software. Vertical displacement will be measured as the distance from the most prominent point of the finish line to the deepest point of gingival sulcus.
up to one month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dental plaque measurement
Time Frame: up to one month

Using the plaque index of Silness and Loe. Each tooth will be scored from 0-3 according to the amount of plaque accumulation.

0: No plaque in the gingival area.

  1. A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
  2. Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
  3. Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
up to one month
Gingival inflammation measurement
Time Frame: up to one month

Using the gingival index of Silness and Loe. Each tooth will be scored from 0-3 according to the degree of gingival inflammation.

0: Normal gingiva

  1. Mild inflammation - slight change in color, slight oedema. No bleeding on probing
  2. Moderate inflammation-redness, oedema and glazing. Bleeding on probing
  3. Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding
up to one month
Gingival Height loss measurement
Time Frame: up to one month
Complete arch maxillary digital impressions (postoperative scans) will be made for each patient by using intraoral scanner after cementation of the crowns. The postoperative scans will be superimposed by the pre-operative scan. A cross sectional line will be drawn in the middle of the superimposed scans and the measurements will be done at 2 points (midbuccal and midlingual). The distance from the gingival margin of the preoperative scan to that of one postoperative scan will be considered gingival height loss at the scan's timepoint
up to one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexandria University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mohamed F Elashry, MSc, Alexandria University
  • Study Chair: Sanaa Hussein, PhD, Alexandria University
  • Study Chair: Ihab Hammad, PhD, Alexandria University
  • Study Chair: Rania Fahmy, PhD, Alexandria University
  • Study Director: Islam M Abdel Raheem, PhD, Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • #2/2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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