NCT07892716

Brief Summary

This study aims to compare two impression techniques, the neutral zone technique and the admixed impression technique, for making complete dentures in patients with atrophic mandibular ridges (severely resorbed lower jaw ridges). A total of 60 patients aged 50-70 years will be included and divided into two groups of 30 patients each. One group will receive complete dentures made using the neutral zone technique, while the other group will receive complete dentures made using the admixed impression technique. Patient comfort during impression making will be assessed and compared between the two techniques to determine which technique provides greater comfort for patients with atrophic mandibular ridges.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Sep 2027

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2027

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

3 months

First QC Date

October 18, 2026

Last Update Submit

October 18, 2026

Conditions

Keywords

neutral zone techniqueadmixed impression techniqueatrophic manibular ridgecomplete denturepatient comfortedentulous mandible

Outcome Measures

Primary Outcomes (1)

  • Mean total patient comfort score during impression making

    Patient comfort during the impression procedure will be assessed using a structured four item questionnaire evaluating difficulty in tongue movements,irritation during impression,difficulty in following the dentists instructions and duration of the impression procedure.Each item will be scored on a 5 point likert scale and the four scores will be summed to obtain total comfort score ranging from 4 to 20.Higher scores indicate greater patient comfort.The mean total comfort scores will be compared between neutral zone and admixed impression teachnique groups.

    Immediately after completion of the impression procedure

Study Arms (2)

Neutral zone technique

EXPERIMENTAL

Paients will undergo mandibular impression making using neutral zone technique for the management of atrophic mandibular ridges.Patient comfort during the impression procedure will be assessed using a structured four item questionnaire

Procedure: Neutral zone impression technique

Admixed impression technique

ACTIVE COMPARATOR

Patients will undergo mandibular impression making using the admixed impression technique for management of atrophic mandiular ridges.Patient comfort during the impression will be assessed using same structure four item questionnaire.

Procedure: Admixed impression technique

Interventions

A denture impressin technique used for fabrication of mandibular complete dentures in patients with atrophic mandibular ridges.The technique records the neutral zone to guide denture tooth arrangement and polished surface.

Neutral zone technique

admixed impression technique for fabrication of complete denture in atrophic mandibular ridges

Admixed impression technique

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 50 to 70 years Completely edentulous in lower jaw Atrophic mandibular ridge as per operational definition Patients coming for new complete denture or havin ill fitting denture

You may not qualify if:

  • History of trauma or surgery history of neuromuscular disorders affecting tongue,lips or cheeks history of oral infections or untreated oral lesions history of systemic conditions where denture impression is not advised history of suitabilty for implant supported prosthesis history of poor cooperation or unable to follow dentists instruction during impression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Raja IM, Hosein M, Khan MA. Comparison between the neutral zone and admixed impression techniques in the management of atrophic mandibular ridges. Med Forum. 2022;33(2):109-113.

    BACKGROUND

Central Study Contacts

Seema kazim, BDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: People will be assigned to one of two parallel groups.Group A will receive the neutral zone impression technique and Group B will receive the admixed impression technique. Outcomes will be compared between the two groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post graduate resident in prosthodontics

Study Record Dates

First Submitted

October 18, 2026

First Posted

October 23, 2026

Study Start (Estimated)

September 1, 2027

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

October 23, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Individual participants level data will not be shared with other researchers.Study findings will be reported in aggregate form whilw maintaining the confidentiality and privacy of participants.