Clinical trial NCT05559632: Peri-Implant Marginal Bone Loss And Implant Stability In Maxillary Implant Overdenture When Using Osseodensification Versus Conventional Drills: A Randomized Clinical Trial
Official title: Peri-Implant Marginal Bone Loss And Implant Stability In Maxillary Implant Overdenture When Using Osseodensification Versus Conventional Drills: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Completely Edentulous Maxilla
Implant Placement
Maxillary Implant Overdenture
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: prof. Nadia Ahmed Abbas
name: dr. Doaa Mahmoud abd elhameed elkady
First posted: 2022-09-29
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Is to compare between the conventional drills versus osseodensification drills for implant stability and peri-implant marginal bone loss in maxillary implant overdenture.

Detailed description: Comprehensive clinical examination and understanding of patient's chief complaints and their expectations from the prosthesis.

* medical and dental history
* A complete denture will be constructed for each patient to aid in the scan technique, if the patient has an denture, it will be evaluated to be used.
* The complete denture will be constructed following conventional denture fabrication procedures.
* CBCT radiograph will be taken for bone height and width, and identify the vital structures before implant placement.
* A surgical guide will be used to aid in the implant placement, each patient will be scheduled for surgery to insert four root form implants. Each patient will receive four implants at canine and premolar regions from the same implant manufacturer.

Study group: The osseodensification drilling group (G1), bone preparation was performed using tapered multifluted burs (Densah Bur; Versah, MI, USA) at 800- 1200 rpm counterclockwise rotation under saline irrigation. Drilling to the desired depth using the tapered densah pilot drill with speed of 800-1200 rpm with copious irrigation without any lateral pressure with clock wise motion.

Control group: In the conventional drilling group (G2), drilling the other contralateral sites of bone using the conventional sequential drilling system according to the manufactural instruction.

* All patients received 2gm/day amoxicillin, clavulanate and 50 mg/8 hours non-steroidal anti-inflammatory analgesics for 5 days postoperatively. Postoperative instructions included a soft diet and appropriate oral hygiene measures with 0.2% chlorhexidine mouth rinse.
* After four months, the implants will be exposed and attachment (stud attachment) will be screwed to the implants. Then, overdenture pick-up is done. \* Number of visits \& follow up period

  * 5 visits for construction of denture
  * 1 visit for CBCT
  * 1 visit for implant insertion
  * 1 visit for attachment placement and pick-up of overdenture
  * Patients will be recalled at base line,4 and 7 weeks 4 and 12 months following implant insertion for outcomes assessment

Eligibility criteria: Inclusion Criteria:

1. Patients with completely edentulous maxilla.
2. Sufficient inter-arch space not less 13mm inter-arch space.
3. sufficient bone height to allow usage of at least 10mm implant length.
4. Normal maxilla-mandibular relationship.
5. minimum radiographic bone width bucco-palatally in canine and premolar regions to place at least 3.5mm implant diameter.
6. participants more than forty years old.
7. Opposing fully or partially restored dentition.

Exclusion Criteria:

* 1- Skeletal mal-relation. 2- Unmotivated patients to maintain adequate oral hygiene to follow up. 3- Patients with neuromuscular and Psychiatric disorders. 4- Systematic disease affecting bone and periodontal health such as diabetic patients.

  5- Insufficient inter-arch space less than 13mm. 6- Patients with physical reasons that could affect follow up. 7- patients administrating antibiotics 8- smoker patients 9- patients with any systemic or local condition that obstacles implant placement 10- patients with a history of radiotherapy in the head and neck region

Primary outcomes:
measure: Peri-implant marginal bone loss
timeFrame: 1 year
Secondary outcomes:
measure: Implant stability measurements
timeFrame: 4 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of dentistry- Cairo university
Study officials:
References: