Clinical and Microbial Evaluation of Two Different Implant Retained Mandibular Overdentures (Randomized Clinical Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Al-Azhar University
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Plaque index
Study Overview
Brief Summary
The aim of removable prosthodontics is not only to restore lost oral structures but also to preserve the remaining tissues. Implant-retained overdentures have shown superior outcomes over conventional dentures by reducing residual ridge resorption, enhancing prosthesis support and retention, and improving patients' quality of life. Retention can be further optimized through the use of various attachment systems such as bars, studs, magnets, and telescopic crowns.
Traditional PMMA denture bases have limited flexibility, making their extension into soft-tissue undercuts challenging. The introduction of flexible resin materials has improved adaptation to deeper undercuts, enhancing retention while minimizing patient discomfort and absorbing functional stresses. Additionally, flexible resins may reduce microbial colonization by improving blood circulation to the underlying mucosa and supporting salivary defense mechanisms against Candida albicans.
Recently, innovative attachment systems such as Novaloc have been developed, featuring PEEK retentive caps and an amorphous diamond-like carbon coating to minimize wear and maintain long-term retention. Their versatile design allows better accommodation of gingival variations and contributes to improved patient satisfaction and treatment success.
Detailed Description
The present study will be performed to compare the difference in microbial accumulation, quality of life and patient satisfaction for implant retained mandibular overdenture using both conventional PMMA and flexible denture base materials.
16 Patients will be equally divided into two treatment groups: Group 1: Each patient in this group will receive conventional maxillary and mandibular complete dentures made of heat-cured acrylic resin. In the mandible, two implants were inserted and retained by Novaloc attachments. Group 2: Patients in this group will receive the same type of treatment as the patients in group1 but the mandibular overdentures were made of the flexible acrylic resin
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Edentulous patients were chosen between the ages of 60 to 70 years old
- •All patients' ridges were covered with firm mucosa,
- •free from any signs of inflammation or ulceration, exhibit adequate height and width of the residual alveolar ridge have sufficient inter arch space.
- •Patients were free from any metabolic or bone disorder that contraindicate implant installation.
Exclusion Criteria
- •Patients with oral or systemic diseases
- •patients with xerostomia or excessive salivation.
- •Patients with parafunctional habits (bruxism or clenching) or history of temporo-mandibular dysfunction or brain disorders or psychiatric disorders.
Outcomes
Primary Outcomes
Plaque index
Time Frame: Follow up visits were scheduled at denture insertion, 6, and 12 months
Amount of plaque accumulation was graded from (0 to 3) where: Grade 0: No plaque detected by passing the side of probe along the implant. Grade 1: Film of plaque detected by probing. Grade 2: Moderate accumulation of soft debris, which can be seen by the naked eye. Grade 3: Too much soft matter within the sulcus, gingival margin, and adjacent implant surface. For each group, four readings were recorded at the middle of the four surfaces, buccal, lingual, mesial, and distal. The mean of the four readings was considered as the plaque index for this group at the chosen times
Pocket depth (Depth of gingival sulcus)
Time Frame: Follow up visits were scheduled at denture insertion, 6, and 12 months
The depth of the gingival sulcus will be measured around each implant using a graduated periodontal probe. This probe will be inserted between the oral sulcular epithelium and the implant with minimal pressure. The distance from the tip of the probe and the free gingival margin will be measured and recorded to the nearest millimeter. Four readings were recorded at the middle of the four surfaces, buccal, lingual, mesial, and distal. The mean of the four readings will be considered as the pocket depth for this group at the chosen time.
Secondary Outcomes
- Patient satisfaction (Questionnaire)(Follow up visits were scheduled at denture insertion, 6, and 12 months.)
- isolation of Candida albicans(Follow up visits were scheduled at denture insertion, 6, and 12 months)
- Oral Health-Related Quality of Life (OHRQoL) (Questionnaire)(Follow up visits were scheduled at denture insertion, 6, and 12 months)
Investigators
Noha Taha Kamel Taha Alloush
Lecturer
Misr International University