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Evaluation of tissue conditioner-assisted complete denture restoration

Evaluation of tissue conditioner-assisted complete denture restoration: a randomised controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN95433057
Enrollment
60
Registered
2024-03-18
Start date
2022-01-01
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Edentulous with severely resorbed alveolar ridges (Atwood classification III or IV) Digestive System

Interventions

The patients will be randomly divided using stratified randomisation into three groups: a conventional impression group (CI group), a closed-mouth impression group (CM group), and a tissue conditioner
Ivoclar Vivadent AG., Schaan, Liechtenstein) will be used by the clinician to make an open-mouth final cast. 3. Temporary denture bases will be made on the final cast by the clinician, using the mand

Sponsors

Wuxi Stomatology Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Physically healthy with a positive mental state and sufficient understanding ability and able to cooperate with the treatment plan and complete the final questionnaire survey 2. Edentulous upper and lower jaws, mandibular alveolar ridge resorption of Atwood class III or IV 3. Flabby ridge: relatively poor mucosal conditions (complex morphology, multiple folds) or edentulous with abused oral tissues and deformation or ulcers resulting from poor stimulation from wearing dentures

Exclusion criteria

Exclusion criteria: 1. Severe systemic diseases, stroke, mobility difficulties or drastic hormone-level changes 2. Severe oral mucosal diseases or limited mouth opening 3. Poor compliance or unwillingness to cooperate with the treatment plan or follow-up 4. Temporomandibular joint disorder syndrome or unstable mandibular positional relationship, stiff and tense perioral muscles or functional degradation

Design outcomes

Primary

MeasureTime frame
The clinical effect of the three impression methods, conventional, closed-mouth and tissue conditioner, on complete denture fabrication measured objectively by the same clinician at 1, 2, 4, and 8 weeks and three months after the final denture completion.

Secondary

MeasureTime frame
Denture quality of all three groups measured objectively by the same clinician using a comprehensive evaluation of denture quality between groups based on age, sex, or Atwood classification and the Oral Health Impact Profile-Edentulous Questionnaire 3 months after the final denture completion at follow-up visits at 1, 2, 4 and 8 weeks

Countries

China

Contacts

Public ContactLi-Qin Gong
liqingong_g61@163.com+86 15061539376

Outcome results

None listed

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