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Implant ComplicationNCT06917638

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

A study testing implant placment in people with Implant Complication, run by Cairo University at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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]. Read more about this study

Who is it for?
Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Implant Complication
What is being tested?
implant placment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteEgypt
Study dates
8 Nov 2023to 20 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Cairo university

    Cairo

Other trials in Egypt

About this study

Official title: Clinical Evaluation of Dental Implant Stability Placed in Healed Bony Sites Using Oversized Drilling Versus Conventional Drilling Protocol: A Randomized Controlled Clinical Trial

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:

Read more

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.
Read the detailed description
  • Pre-operative evaluation

Clinical examination:

  • Evaluation of the general condition of the oral cavity of the patients will be performed to make sure it will comply with the criteria required to be enrolled in the study in terms of oral hygiene, pathological conditions, and inter-arch space.
  • When the patients meet the clinical selection criteria, radiographic examination will follow.

Radiographic examination:

  • A pre-operative periapical x-ray will be performed for each of the patients who met the clinical selection criteria to increase chances of eligibility prior to a pre-operative Cone Beam Computed Tomography (CBCT). This will be done to avoid unnecessary extra expenses of a CBCT and unnecessary radiation exposure.
  • A pre-operative CBCT will be performed for each of the patients who met the clinical and primary radiographic selection criteria to ensure eligibility prior to the surgery.

From the obtained CBCT, the bone height, width and density will be determined.

  • Once the patients passes both the clinical and radiographic selection criteria, they will be enrolled by the investigator into the study.
  • The enrolled patients will then be provided with a full explanation of the aim and benefits of the study in plain language, then, given the chance to have an informed discussion with the investigator.
  • Once the patients approve the intervention and agree to comply with the study guidelines, they will sign a written informed consent form translated in Arabic.

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.

  • 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.

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).
  • Anti-inflammatory drugs (NSAIDS; Ibuprofen 600mg three times daily for 5 days) to avoid any chance of oedema or pain or swelling (Francesco pieri et al, 2012).
  • Antiseptic mouth rinse (0.12% Chlorhexidine oral rinse will be prescribed for 60 seconds two times a day for 14 days. (Jun Yu et al, 2015)

The patient will be instructed to:

  • Apply an ice pack to the treated area for the first 24 hours. (Francesco pieri et al, 2012).
  • Avoid any brushing or trauma to the surgical site for one week. (Francesco pieri et al, 2012). The patient will be instructed to come in for weekly follow ups over the course of the following 3 months after implant placement for recording Ostell readings. After 6 months following the implant placement, (Paolantoni et al. 2013) healing collar will be removed, and impressions (indirect, open or closed tray technique) will be taken to fabricate the final crowns followed by crown placement.
Being tested
implant placment
Keywords
implant stability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • implant placmentProcedure or surgery

    • 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.
Study groups in NCT06917638
Study groupRoleWhat they receive
Control Group: Under-sized drilling group (UD)Active comparatorManufacturer-recommended implant osteotomy preparation will be done according to the manufacturer guidelines with the final drill the same diameter of the implant.
Receives: Procedure: implant placment
Intervention Group: oversized drilling (OD)Active comparatorOsteotomy preparations for the oversized drilling group will include an extra drill, which will be 0.2mm wider than the diameter of the implant.
Receives: Procedure: implant placment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Implant stability quotient (ISQ)

    resonance frequency analysis

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

Secondary outcomes (1)
  1. • 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2025
  2. Study start8 Nov 2023
  3. Primary completion20 May 2025 (estimated)
  4. Study completion20 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06917638
Sponsor's protocol ID
https://cu.edu.eg/ar/Home
Status last verified
Mar 2025
First submitted
17 Mar 2024
Last updated
8 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34411219

Questions about this trial

What is this clinical trial studying?

A study testing implant placment in people with Implant Complication, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implant stability quotient (ISQ) (time frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks postoperatively.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06917638, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.

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