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Efficacy of three types of impression materials in terms of retention of Maxillary complete denture

Comparison of retention of trial denture bases of complete dentures made with three types of impression material in edentulous patients.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001198415
Enrollment
32
Registered
2025-10-31
Start date
2025-11-11
Completion date
2026-08-13
Last updated
2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of this study is to compare retention of maxillary trial denture bases of complete dentures made with three types of impression material in edentulous patients. Null Hypothesis (H0): There is a significant difference in the retention of the Denture Trial Bases obtained from three different types of impression material. Alternate Hypotheses (H1): There is no difference in the retention of the Denture trial bases obtained from three different types of impression materials.

Interventions

In intervention group, first a single step Sodium Alginate impression will be recorded in a stock tray. And then five minutes after that, a second impression with Condensation Silicone impressions material will be recorded in another stock tray. The size of the stock tray will be 3 mm wider than the edentulous maxillary ridges for both the impression materials. Both the impression materials will be mixed manually according to manufacturer's instructions and loaded in stock tray already selected.

In intervention group, first a single step Sodium Alginate impression will be recorded in a stock tray. And then five minutes after that, a second impression with Condensation Silicone impressions material will be recorded in another stock tray. The size of the stock tray will be 3 mm wider than the edentulous maxillary ridges for both the impression materials. Both the impression materials will be mixed manually according to manufacturer's instructions and loaded in stock tray already selected. The patient will be seated in dental chair in an upright position. The maxillary arch height should be at elbow level of operator and operator will be standing at 11:00 Oclock position to the patient while recording impression. Each impression will be recorded by specialist prosthodontics ( Principal investigator having more than 13 years of experience in Prosthodontic specialty). After recording the impression, it will be verified by two other prosthodotnics specialists for acceptance of accuracy. If any of the two impression is considered unacceptable , the procedure will be repeated for that particular impression material . The thickness of set impression materials will be kept to 3 mm. These impressions will be poured and trial denture base (TDB) will be fabricated on the casts obtained from these two impressions. The retention of TDB will be compared with the controlled/comparator group. The time required to record impression for each procedure will be recorded in visits and minutes to complete the impression procedure.

Sponsors

Shafi ullah khan, Khyber college of dentistry
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
35 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

-Patients with edentulous maxillary arch requiring new complete maxillary denture -Tall u-shaped maxillary residual ridges -with class I palatal throat form

Exclusion criteria

-patients having palatine torus or oral tumour, -patients with oral deformity like Oro-nasal or Oro-Antral fistulas, sever undercuts -patients having xerostomia, -Cleft lip and palate patients -Patients having systemic illness eg pregnancy, debelatated - Patients having a known hypersensitivity to silicone, alginate or Zinc Oxide Eugenol

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026