Actively Recruiting

Phase Not Applicable
Age: 20Years - 60Years
All Genders
Healthy Volunteers
ID06307691

Clinical and Radiographic Evaluation of Immediate Implant Placement Using Osseodensification Versus Traditional Drilling Protocol

Led by Cairo University · Updated on 2024-03-19

26

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two methods for placing immediate dental implants in the front upper jaw area. The study evaluates the traditional drilling technique versus an osseodensification drilling method that compresses bone to improve implant stability, especially in cases of low bone volume. The goal is to assess how these two drilling protocols affect implant stability and bone health after placement. The study involves two groups: Group A receives implants placed using traditional drilling, which cuts the bone to create space for the implant. Group B uses the osseodensification technique with Densah burs that compress the bone around the implant site to enhance bone density. Both methods involve atraumatic flapless tooth extraction, followed by implant placement at a position slightly below the bone crest. Post-surgery, patients receive antibiotics, anti-inflammatory medications, and antiseptic mouth rinses to support healing. Participants undergo thorough preoperative assessments, including clinical and radiographic exams such as Cone Beam CT scans and periapical X-rays. Follow-up includes monitoring implant stability weekly up to 12 weeks and evaluating bone levels immediately after surgery and at 3 and 6 months. Definitive implant restorations are placed around 6 months after surgery. The study duration and visits are designed to track healing, implant integration, and bone changes over time.

CONDITIONS

Brief Title

Clinical and Radiographic Evaluation of Immediate Implant Placement Using Osseodensification Versus Traditional Drilling Protocol

Who Can Participate

Age: 20Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients needing extraction of a single, unrestorable tooth in the esthetic zone including maxillary anteriors and premolars
  • Age between 20 and 60 years old
  • Intact buccal bone plate after extraction
  • Medically healthy patients
  • Cooperative patients willing to follow up for the study duration
Not Eligible

You will not qualify if you...

  • Acute infection at the implant site
  • Inability to maintain oral hygiene
  • Pregnant or nursing women
  • Smokers of more than 5 cigarettes per day
  • Habit of teeth grinding (bruxism)
  • Periodontal disease
  • Systemic diseases affecting bone healing, such as diabetes
  • Use of bone metabolism medicines like bisphosphonates

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for history, clinical and radiographic examination

Treatment

Duration - Single day for surgery and implant placement with postoperative care over several weeks

Participants undergo atraumatic tooth extraction followed by immediate implant placement using either conventional drilling or osseodensification drilling protocols. Postoperative care includes medications and self-care instructions.

1 surgical visit plus weekly visits for implant stability checks up to 12 weeks

Follow-up

Duration - Up to 6 months after surgery

Participants receive postoperative radiographs and definitive restoration placement approximately 6 months after surgery to assess healing and implant integration.

Radiographic visits at 1 week, 6 months, and 9 months; definitive restoration visit around 6 months

Trial Site Locations

Total: 1 location

1

Faculty of Dentistry Cairo University

Cairo, Egypt

Actively Recruiting

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Research Team

O

Omar M Ibrahim, Master

O

omnia K tawfik, Lecturer

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Immediate rehabilitation of the edentulous jaws with full fixed prostheses supported by four implants: interim results of a single cohort prospective study.

Enrico Agliardi, Stefano Panigatti, Matteo Clericò...

https://pubmed.ncbi.nlm.nih.gov/20105197

Influence of Bone Quality, Drilling Protocol, Implant Diameter/Length on Primary Stability: An In Vitro Comparative Study on Insertion Torque and Resonance Frequency Analysis.

Davide Farronato, Mattia Manfredini, Michele Stocchero...

https://pubmed.ncbi.nlm.nih.gov/32582919

New Osseodensification Implant Site Preparation Method to Increase Bone Density in Low-Density Bone: In Vivo Evaluation in Sheep.

Paolo Trisi, Marco Berardini, Antonello Falco...

https://pubmed.ncbi.nlm.nih.gov/26584202