The Efficacy of Different Gingival Displacement Methods Before Definitive Digital Impression

Not Applicable

Completed

• Conditions: Gingival Displacement
• Interventions: Device: Laser troughing; Other: Retraction cord and astringent; Other: Cordless retraction paste with astringent; Other: Cordless retraction paste without astringent

• Registration Number: NCT06132815
• Lead Sponsor: Alexandria University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-30
• Status Verified: 2023-11
• Study First Submitted: 2023-11-10
• Study First Submitted QC: 2023-11-10
• Last Update Submitted: 2023-11-10
• Study First Posted: 2023-11-15
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser troughing	Laser troughing	-
Retraction cord and astringent	Retraction cord and astringent	-
Cordless retraction paste with astringent	Cordless retraction paste with astringent	-
Cordless retraction paste without astringent	Cordless retraction paste without astringent	-

Primary Outcome Measures

Name	Time	Method
Horizontal displacement measurement	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).
Vertical Displacement measurement	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.

Secondary Outcome Measures

Name	Time	Method
Gingival inflammation measurement	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
Gingival Height loss measurement	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
Dental plaque measurement	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt