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Comparison of denture tooth position using two neutral zone techniques

Randomised Control Trial (RCT) comparing the lower anterior labio-lingual neutral zone position in edentulous subjects with and without their upper denture in-situ

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN56080673
Enrollment
24
Registered
2012-07-30
Start date
2012-06-20
Completion date
Unknown
Last updated
2018-03-26

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

Conditions

Edentulousness Oral Health

Interventions

One study arm involves recording the neutral zone impression whilst the patient wears their upper denture. The other study arm is the same but the patient does not wear their upper denture. The order
i.e. that after insertion of the impression tray and placement of the impression material they will be instructed to perform the following mouth movements: 1. Brush the tip of their tongue along their
in accordance with the instructions in the envelope (i.e. if no upper denture in place for the first procedure then it will be used for the second impression and vice-versa). The total duration for b

Sponsors

University of Leeds (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. At least 18 years old 2. Patient able to attend a 1 hour appointment in addition to their scheduled sequence required for full denture provision 3. Edentulous 4. Competent to freely give positive consent for participation 5. Does not have an allergy to acrylic or Optisil 6. Having complete dentures fabricated for them at the Leeds Dental Institute

Exclusion criteria

Exclusion criteria: 1. No known allergy to Optisil 2. Does not have severe xerostomia (Sjogren?s syndrome) 3. Does not have an oral tumour 4. Does not require an obturator

Design outcomes

Primary

MeasureTime frame
To establish whether the 'neutral zone' recording is influenced by the presence of the patient's upper complete prosthesis. (A 'neutral zone' recording is a dental impresion technique designed to record the optimal balanced position in the mouth for denture teeth to sit.)

Secondary

MeasureTime frame
No secondary outcome measures

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026