The Efficacy of Different Gingival Displacement Methods Before Definitive Digital Impression

NCT06132815 | Completed

• 1 other identifier: #2/2022
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Displacement

Outcome Measures

Primary Outcomes (2)

• Horizontal displacement measurement

  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

  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 Outcomes (3)

• Dental plaque measurement

  up to one month

• Gingival inflammation measurement

  up to one month

• Gingival Height loss measurement

  up to one month

Study Arms (4)

Laser troughing

EXPERIMENTAL

Device: Laser troughing

Retraction cord and astringent

EXPERIMENTAL

Other: Retraction cord and astringent

Cordless retraction paste with astringent

EXPERIMENTAL

Other: Cordless retraction paste with astringent

Cordless retraction paste without astringent

ACTIVE COMPARATOR

Other: Cordless retraction paste without astringent

Interventions

Laser troughing DEVICE

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

Laser troughing

Retraction cord and astringent OTHER

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

Retraction cord and astringent

Cordless retraction paste with astringent OTHER

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.

Cordless retraction paste with astringent

Cordless retraction paste without astringent OTHER

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.

Cordless retraction paste without astringent

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

MeSH Terms

Interventions

Astringents

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses

Study Officials

• Mohamed F Elashry, MSc

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Sanaa Hussein, PhD

  Alexandria University

  STUDY CHAIR

• Ihab Hammad, PhD

  Alexandria University

  STUDY CHAIR

• Rania Fahmy, PhD

  Alexandria University

  STUDY CHAIR

• Islam M Abdel Raheem, PhD

  Alexandria University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Fixed Prosthodontics

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 15, 2023
• Study Start: June 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 30, 2023
• Last Updated: November 15, 2023

Record last verified: 2023-11

Locations

EG (1)