The comparison of two different full denture concepts

Randomized Prospective Clinical Study comparing the Bilateral Balanced Occlusion and Anterior/Canine Guidance in Participants wearing Complete Dentures

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13728393

Enrollment

Registered

2018-05-25

Start date

2007-07-15

Completion date

Unknown

Last updated

2018-06-18

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

Conditions

Dentures Oral Health Dentures

Interventions

All participants receive complete overdentures with anterior/canine guidance and the bilateral balanced occlusion using a crossover design. The participants are randomised to one of two groups. Those

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Presence of two functional, aesthetically acceptable complete maxillary and mandibular dentures, not to be more than two years old 2. A bilateral balanced set-up of the denture teeth 3. Good general and mental health 4. Participant compliance 5. Dentures to be worn for the entire six-month study period 6. No scars or grafts in the oral cavity 7. No functional complaints 8. Inconspicuous oral mucosa 9. Sufficient ability to communicate

Exclusion criteria

Exclusion criteria: 1. Refusal to participate 2. Extended illness 3. Lack of compliance 4. Communication problems 5. Severe physical or mental illness 6. Craniomandibular dysfunction

Design outcomes

Primary

Measure	Time frame
1. Positional change of maxillary and mandibular denture is measured using clinical examination of two investigators at the end of each testing phase 2. Masticatory efficiency is measured using a numerical rating questionnaire at the end of each testing phase 3. Speech performance is measured using a numerical rating questionnaire at the end of each testing phase 4. Satisfaction is measured using a numerical rating questionnaire at the end of each testing phase 5. Chewing comfort and masticatory efficiency are measured using a numerical rating questionnaire at the end of each testing phase 6. Comfort of the dentures is assessed using a numerical rating questionnaire at the end of each testing phase	—

Measure

Time frame

1. Positional change of maxillary and mandibular denture is measured using clinical examination of two investigators at the end of each testing phase 2. Masticatory efficiency is measured using a numerical rating questionnaire at the end of each testing phase 3. Speech performance is measured using a numerical rating questionnaire at the end of each testing phase 4. Satisfaction is measured using a numerical rating questionnaire at the end of each testing phase 5. Chewing comfort and masticatory efficiency are measured using a numerical rating questionnaire at the end of each testing phase 6. Comfort of the dentures is assessed using a numerical rating questionnaire at the end of each testing phase

—

Secondary

Measure	Time frame
1. Mechanical retention is measured using clinical examination of two investigators at the end of each testing phase 2. Resorption class for maxilla and mandible is assessed using clinical examination of two investigators at the end of each testing phase	—

Countries

Germany

Outcome results

None listed

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