Evaluation of Marginal Bone Loss of Two Immediately Loaded Implants Retaining Mandibular Overdentures With Ball Attachment Versus Intra Oral Welding Titanium Bar a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- marginal bone loss measurement
Study Overview
Brief Summary
It is a randomized control clinical trial in which maxillary and mandibular dentures will be constructed, two implants will be inserted in the inter foraminal region in the edentulous mandible and immediate loading will be done. We will be comparing peri-implant marginal bone loss of two immediately loaded implants retaining mandibular overdentures with ball attachment versus intra oral welding titanium bar. Patient satisfaction will be assessed using oral health related quality of life.
Detailed Description
The patients will be divided in two groups, each group will receive maxillary and mandibular conventional heat cured acrylic resin complete dentures, which will be duplicated and provided by radio-opaque resin at the proposed implant sites to act as radiographic stents. Only patients with a D2 or D3 bone density will be included in the study. This will be confirmed by their cone beam computed tomographic (CBCT) scans of the mandible, while wearing radiographic stents.
The CBCT will be used to ensure sufficient bone width at the proposed implant sites, namely canine regions for implant diameter 3.7. Diagnostic set ups for all patients will be prepared to ensure a crown height space of at least 12 mm to accommodate the ball attachments for group I and intra oral welding bar for group II. Each group will receive two implants in the canine region through using surgical stent and immediate loading will be done.
Group B: immediate loading will be done using ball attachment and soft liners acting as female part for mandibular overdenture.
Group I: immediate loading will be done using intra oral welding titanium bar with 2 mm diameter and soft liner acting as a female part for mandibular overdenture.
For each group, marginal bone loss around the implants will be assessed at time of denture delivery and six months later. Patient satisfaction will be assessed using oral health related quality of life using (OHRQOL 14)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Blinding will be done by the outcomes assessor and one of the study authors will remove the prosthetic part before measuring crestal bone loss by outcome assessor through cone paralling technique. Blinding of the outcomes assessor for assessment by oral health questionnaire will be done as well
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •good oral hygiene
- •patient will be medically free
- •sufficient inter arch space
Exclusion Criteria
- •heavy smoker
- •TMJ disorders
- •uncontrolled diabetes
- •flappy tissue
Arms & Interventions
mplant supported overdenture by ball attachment
immediate loaded implant supported overdenture by ball attachment
Intervention: implant supported overdenture by ball (Procedure)
implant supported overdenture by bar
immediate loaded implant supported overdenture by intraoral welding titanium bar splinted two implant
Intervention: implant supported overdenture by bar (Procedure)
Outcomes
Primary Outcomes
marginal bone loss measurement
Time Frame: 6 months
marginal bone loss will be measured mesial and distal to the implant by radiographic cone paralling technique
Secondary Outcomes
- patient satisfaction(6 months)
Investigators
Ahmed Mostafa Abdelfatah
associate professor of oral and maxillofacial prosthodontics
Ain Shams University