Clinical trial NCT05895292: Conventional Versus Neutral-Zone CAD/CAM Dentures Restoring Mandibular Resorbed Ridges
Official title: Digital Analysis of Denture Space Confines and Patient's Satisfaction for Conventional Versus Neutral-Zone CAD/CAM Dentures Restoring Mandibular Resorbed Ridges.(Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Denture, Complete
Keywords: CAD/CAM
Denture, Complete
Patient Satisfaction
Dental Impression Technique
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is a within-subject randomized clinical trial that will compare and evaluate patients' satisfaction and digitally analyze denture space Confines. Group I: CAD/CAM. (computer-aided design/computer-aided manufacturing) Conventional complete dentures will be designed based on the bone support concept, Group II: CAD/CAM neutral zone complete dentures will be designed based on the neutral zone concept. The participants will be selected according to inclusion and exclusion criteria and will be randomly allocated into both groups and then shuffled to the other group using the Research Randomizer Program.

Detailed description: This study is designed as a randomized clinical trial applying a within-subject comparison of two different complete denture types as follows; group I: CAD/CAM conventional complete dentures will be designed based on the bone support concept, group II: CAD/CAM neutral zone complete dentures will be designed based on the neutral zone concept. The study will be carried out on twelve completely edentulous patients exhibiting advanced residual ridge resorption, each patient will receive two sets of complete dentures in a random sequence, and each set of CDs will be worn for at least eight weeks after the last recall visit before assessments. Upon delivery of the second set of CDs, the first set will be withheld from the patient. For each denture set, patient satisfaction will be rated using a patient denture assessment PDA questionnaire that will be assessed via a Likert scale, the obtained scores will be used to compare the two denture types. Also by using special digital software, a comparison between group I and II virtual complete denture images will be conducted.

Eligibility criteria: Inclusion Criteria:

1. Patients who have been completely edentulous in both jaws (maxilla and mandible) for a long period.
2. The age of patients ranges from 50 to 80 years old.
3. Patients with a resorbed mandibular ridge.
4. Patients with a Class I maxillo-mandibular relationship
5. Patients with adequate inter-arch space.
6. Patients with good neuromuscular control.
7. Patients without any tempo-mandibular disorder.

Exclusion Criteria:

1. Patients with any oral diseases that may affect complete denture construction
2. Patients with bad oral hygiene.
3. Patients with oral parafunctional habits.
4. Hysterical patients.
5. Patients will undergo or have previously received chemotherapy or radiotherapy.
6. Drug-addicted patients.

Primary outcomes:
measure: Digital Analysis and Comparison of Denture Space Confines for CAD/CAM Dentures Based on the bone-support concept Versus based on the neutral-zone concept Restoring Mandibular Resorbed Ridges using "Medit compare" digital software.
timeFrame: before manufacturing of complete removable denture
Secondary outcomes:
measure: Evaluation of patients' satisfaction with both types of the Complete Removable Dentures
timeFrame: three months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Ain shams University
state: Nasr City
Study officials:
References:
citation: Bhorgonde D, Nandakumar K, Khurana PR, Kumari VS, Reddy MS, Siddique S. An evaluation of the position of the neutral zone in relation to the crest of mandibular alveolar ridge - An In-vivo study. J Int Oral Health. 2014 Apr;6(2):45-54. Epub 2014 Apr 26.
citation: Choi S, Kim S, Chang JS. The Neutral Zone Approach with CAD-CAM Record Bases. J Prosthodont. 2022 Jul;31(6):459-463. doi: 10.1111/jopr.13502. Epub 2022 Mar 24.