Digital Versus Conventional Impression in Edentulous Patients With Flabby Ridge.

NCT07108322 | Completed DMC

• 1 other identifier: FODMRC-2023-00111
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of complete denture prosthodontics is to restore function, comfort, and aesthetics by replacing missing teeth and supporting structures. Flabby ridges, defined as mobile soft tissue on the alveolar ridge, pose challenges in creating stable dentures, as these tissues can displace under occlusal forces, compromising retention and support. Special impression techniques are necessary to manage flabby ridges effectively One widely accepted method is the window technique, which uses double spacers and window in the flabby tissue area. However, this technique is technically complex. This RCT aims to evaluate whether intraoral scanning (IOS) provides an alternative to the window technique for recording maxillary flabby ridges. The hypothesis was that IOS will demonstrate superior clinical results in terms of both Retention and Patient satisfaction compared to the conventional window technique impression (WTI).

Conditions

Flabby Ridge; Edentulous Alveolar Ridge

Keywords

Flabby ridge; Edentulous; Maxillary; digital scanning

Outcome Measures

Primary Outcomes (1)

• patient satisfaction

  A questionnaire will be provided to score Oral Health Related Quality of Life . The scoring system used a Likert scale where a lower score indicates a better perceived quality of life, as the minimum possible score is 0 and the maximum is 76 (higher score indicating more impairment).

  Baseline, 3 months and 6 months

Secondary Outcomes (1)

• Retention

  Baseline, 3 months and 6 months

Study Arms (1)

Edentulous maxillary arch with flabby ridge

OTHER

Conventional impression followed by intraoral scanning

Other: Intraoral scanning

Interventions

Intraoral scanning OTHER

Adigital impression with intraoral scanning

Edentulous maxillary arch with flabby ridge

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completely edentulous patients with maxillary flabby ridge
• Absence of infectious diseases
• Systemic good health (ASA-1/ASA-2)
• Age between 50 and 75 years
• Willingness to cooperate throughout the data collection process.

You may not qualify if:

• Presence of any remaining teeth
• Inability to comprehend the study's objectives and procedures
• ridge defect or lesion
• Postoperative scarring on the ridge
• Limitations in mouth opening.

Sponsors & Collaborators

• Delta University for Science and Technology: lead

Study Sites (1)

Delta University for Science and Technology

Alexandria, Egypt

Location

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Dina M. ElAwady, PHD

  Associate Professor of Prosthodontics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 7, 2025
• Study Start: March 30, 2023
• Primary Completion: April 29, 2025
• Study Completion: June 25, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)