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The goal of this [type of study: clinical trial] is to [investigate the influence of Oversized Drilling Versus Traditional for implant Stability and Crestal Bone Loss.] in [ Healthy Patient aged between 20 and 60 years with one missing tooth in the posterior mandible with sufficient bone dimensions].
The main question[s] it aims to answer are:
the influence of oversized drilling versus traditional drilling in the mandibular arch, in terms of implant stability and crestal bone levels. The effects of oversized protocol have not been fully explored on the more compact mandibular bone.
Participants will Control Group: Under-sized drilling group (UD):
Manufacturer-recommended implant osteotomy preparation will be done according to the manufacturer guidelines with the final drill the same diameter of the implant. Intervention Group: oversized drilling (OD) Osteotomy preparations for the oversized drilling group will include an extra drill, which will be 0.2mm wider than the diameter of the implant.
• Pre-operative evaluation
Clinical examination:
Radiographic examination:
From the obtained CBCT, the bone height, width and density will be determined.
Patient preparation:
The enrolled participants will be prepared 2 weeks prior to the surgery. This will include professional scaling, oral hygiene instructions and treatment of any caries or defective fillings present around the surgical site.
Diagnostic impressions will be taken using alginate impression material during the preparation phase.
After the cast is poured out, a radiographic stent will be created at the area of interest using cold cure acrylic material. This will be done by the aid of an x-ray holder consisting of an acrylic customized bite block, a metallic indicator arm and a radiographic rim. The aim of this step is to standardize the position of the digital xray for each site in order to ensure reproducibility between follow ups when measuring crestal bone loss.
- Surgical procedure:
After local anaesthesia, a crestal incision will be performed at the site using a 15c blade followed by full thickness mucoperiosteal flap elevation to expose the underlying bone. A periodontal probe will then be used to help locate the correct point of drilling. This will be done by leaving a margin(1mm) between the buccal plate and the osteotomy, a margin(1mm) between the lingual plate and the osteotomy, A margin(1.5mm) between the neighboring tooth and the osteotomy.
A round bur will used to mark the point of drilling located by the periodontal probe.
The drilling (1200 rpm) will then performed under copious irrigation with normal saline sequentially according to the manufacturer's instructions to reach the final drill corresponding to the implant size.
Allocation concealment will be broken at this point to assign the patient into one of two groups:
Control Group: Under-sized drilling group (UD):
Manufacturer-recommended implant osteotomy preparation will be done according to the manufacturer guidelines with the final drill the same diameter of the implant. Intervention Group: oversized drilling (OD) Osteotomy preparations for the oversized drilling group will include an extra drill, which will be 0.2mm wider than the diameter of the implant.
Postoperative instructions and follow up:
The patient will be instructed to take:
- Antibiotics (Amoxicillin 1g twice daily for 5 days) to prevent any chance of infection.
(Eugenio Romeo et al, 2014).
The patient will be instructed to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group: Under-sized drilling group (UD) | Active Comparator | Manufacturer-recommended implant osteotomy preparation will be done according to the manufacturer guidelines with the final drill the same diameter of the implant. |
|
| Intervention Group: oversized drilling (OD) | Active Comparator | Osteotomy preparations for the oversized drilling group will include an extra drill, which will be 0.2mm wider than the diameter of the implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| implant placment | Procedure |
Control Group: osteotomy preparation the same diameter of the implant. Intervention: oversized drilling:Osteotomy preparations will include an extra drill,(0.2mm) wider than the diameter of the implant.
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant stability quotient (ISQ) | resonance frequency analysis | 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| • crestal bone levels (day of the surgery (baseline), at 3 and 6 months postoperatively) • pain • swelling • satisfaction • implant survival | parallel technique periapical radiography VAS Categorical scale Questionnaire Categorical scale | (day of the surgery (baseline), at 3 and 6 months postoperatively) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo university | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34411219 | Result | Seleem A, Tawfik OK, El-Nahass H. Evaluation of Oversized Drilling on Implant Survival and Stability Versus Traditional Drilling Technique: A Randomized Clinical Trial. Int J Oral Maxillofac Implants. 2021 Jul-Aug;36(4):771-778. doi: 10.11607/jomi.8777. |
| Label | URL |
|---|---|
| Oversized implants | View source |
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Patients will be randomly selected into either group using computer generated randomization using (www.randomizer.org).
The randomized numbers will be allocated to each site in each patient and will be placed in opaque, sealed and sequentially numbered envelopes. Patients will be randomly allocated to test and control groups using the randomization schedule.
Masking/blinding:
|