Dental Implant Stability Placed in Healed Bony Sites Using Oversized Drilling Versus Conventional Drilling Protocol

NCT06917638 | Active Not Recruiting DMC

• 1 other identifier: https://cu.edu.eg/ar/Home
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

• Once the osteotomy is ready, the appropriate implant will be placed manually at first and then progressed using a ratchet.
• After the implant is correctly placed, a smart peg will be attached to the implant via hand screwing, to measure its stability using Ostell and four readings will be recorded: a mesial, distal, buccal and lingual reading.
• The smart peg will then be removed and will be replaced with a healing collar above the gingival margin.
• The flap will then be sutured back to its original position around the healing collar with an interrupted suture.
• A standardized digital periapical radiograph will be taken using a radiographic holder and a custom-made radiographic stent to determine the initial crestal bone level.

Conditions

Implant Complication

Keywords

implant stability

Outcome Measures

Primary Outcomes (1)

• Implant stability quotient (ISQ)

  resonance frequency analysis

  1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks postoperatively.

Secondary Outcomes (1)

• • crestal bone levels (day of the surgery (baseline), at 3 and 6 months postoperatively) • pain • swelling • satisfaction • implant survival

  (day of the surgery (baseline), at 3 and 6 months postoperatively)

Study Arms (2)

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.

Procedure: implant placment

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.

Procedure: implant placment

Interventions

implant placment PROCEDURE

* Crestal incision followed by full thickness mucoperiosteal flap elevation. * Drilling of the implant 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: 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. * A smart peg will then be attached to the implant, to measure its stability using Ostell and three readings will be recorded:occlusal buccal and lingual reading. * A healing collar will then be place over the implant, then simple intrerupted suture * A standardized digital periapical radiograph will be taken using a radiographic holder and a custom-made radiographic stent to determine the initial crestal bone level.

Control Group: Under-sized drilling group (UD); Intervention Group: oversized drilling (OD)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with a single missing tooth in the posterior region of the mandibular arch.
• Bone dimensions buccolingual (not less than 6mm) and apicocoronal (not less than 10mm)
• Patients with healthy systemic condition. (Brightman. 1994)
• Patients aged from 20 to 60 years old.
• Good oral hygiene. (Wiesner et al. 2010)
• Accepts 6 months follow-up period (cooperative patients)

You may not qualify if:

• Patients with signs of acute infection related to the area of interest.
• Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits or alcoholism (Lobbezoo et al. 2006).
• Smokers (Bruno Ramos Chrcanovic et al. 2015) (25).
• Pregnant women
• Patients on medication that may interfere with healing (corticosteroids, bisphosphonate, Chemo/radio therapy).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, Egypt

Location

Related Publications (1)

• 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.

  PMID: 34411219 BACKGROUND

Related Links

• Oversized implants

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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: * Participants will be blinded. * Blinding of the operator will not be applicable * The outcome assessor will be blinded * The biostatistician will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Masters student

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: April 8, 2025
• Study Start: November 8, 2023
• Primary Completion: May 20, 2025
• Study Completion (Estimated): May 20, 2026
• Last Updated: April 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)