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

March 16, 2024 updated by: Omar Mostafa Ibrahim Omar, Cairo University

For the purpose of the study, patients will be divided into two groups, i.e., Group A and Group B. In Group (A), 14 immediate implants will be placed using traditional drilling technique, while in Group (B), 14 immediate implants will be placed using OD drilling technique Osseodensification is a system for implant osteotomy preparation, it compresses the cancellous bone around the revolving drills. It largely improves low bone volume by physically increasing the interlocking between the bone and the implant surface. The Densah burs enhances bone density while generating the least amount of heat.

Traditional oversized drilling is the regular manufacturer recommended technique of drilling. It functions by cutting the bone during osteotomy preparation by sharp fluted drills. The undersizing of the preparation allows the implant to partially compact the bone during insertion.

The objective of the current study is to compare between osseodensification drilling protocol versus traditional undersized drilling protocol in immediate implant placement in anterior maxillary region in terms of implant stability.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Preoperative preparation:

A thorough preoperative assessment of all patients will be carried out including history taking, clinical examination and radiographic examination.

10

● History: Each patient will be interviewed in order to obtain a comprehensive history.

● Clinical examination:

Proper intraoral examination will be done to evaluate the following parameters for the tooth of interest:

  1. Restorability of the tooth.
  2. Relation to adjacent teeth and the available mesio-distal space.
  3. Relation to the opposing teeth and the available interarch space. Intraoral examination will be done for all study participants to ensure compliance with the study inclusion criteria.

Full mouth supragingival debridement will be performed for all participants to ensure gingival health. Oral hygiene An impression will be taken for all study participants to create a study cast on which a radiographic stent will be created to allow standardized parallel technique radiographs to be taken for the patient in the study.

Radiographic examination:

  • Periapical radiographs will be done to rule out the presence of any periapical infection and evaluate the presence of caries or periodontal disease in the adjacent teeth.

  • Cone Beam Computed Tomography (CBCT) will be taken for each patient to assess:

    1. Bucco-lingual width of bone (measured 1 mm below the alveolar crest).
    2. Mesio-distal width of bone.
    3. Corono-apical height of bone.
    4. Presence of labial undercut, dehiscence or fenestration.
    5. Relation to vital structures as nasal floor and maxillary sinus.

    6. Relation to adjacent teeth.

      B. Surgical Procedure:

    1. Local anesthesia in which Septocaine (Articaine hydrochloride 4% with 1:100000 Epinephrine) will be administered via buccal and palatal infiltration prior to any surgical procedure.
    2. In both groups, flapless atraumatic tooth extraction will be performed which includes an intrasulcular incision using a 15c blade, then a periotome will be inserted between the root and the surrounding bone in a wedging action around the root. A small sized straight elevator will be used to luxate the root 11

    3. A Lucas curette will be used to clean the extraction socket of any apical pathology and granulation tissue. 4. A periodontal probe will be used to evaluate the integrity of the bone walls and decide whether the minimum bone height required for implant placement is present. 5. Randomization will be broken at this point to determine which treatment the patient will recieve.

      For Group A: (traditional implant placement) ● A pilot drill will be used to create an osteotomy at the base of the socket and decide implant trajectory. implant diameter will be chosen based on the tooth or its socket apical diameter. ● The surgical motor will be set at a speed of 800-1000 rpm and 1:20 reduction torque.

      • Traditional drills will be used in sequence as per the manufacturer recommended protocol.

      For Group B: (Ossedensification protocol) ● Osteotomy will be prepared using Osseodensification drills in sequence as per the manufacturer recommended protocol. ● The surgical motor will be set at a speed of 800-1000 rpm and 1:20 reduction torque.

    6. Implant placement will finally be done by slowly torquing the implant into the osteotomy, placing the implant in a subcrestal position (1-2mm below crestal bone), with a jumping gap at least 2mm from the buccal bone plate.

    7. A healing collar will be placed over the implant to allow the implant healing to be monitored during the early phase of healing.

C. Postoperative care:

Administration of:

  1. Antibiotics (Amoxicillin 500 mg orally four times daily for 5 days).
  2. Anti-inflammatory drugs (NSAIDS; Ibuprofen 600mg three times daily for 3 days then whenever needed).
  3. Antiseptic mouth rinse (0.2% Chlorhexidine oral rinse) will be prescribed twice per day for two weeks.

12

Patient self-care instructions:

  • Avoid any hard brushing and trauma to the surgical site for two weeks.
  • Plaque control will be maintained by chlorohexidine for a month after the surgery.
  • After this period, patients will be instructed to continue mechanical tooth cleaning again of the treated sites using a soft toothbrush and roll technique for one month in addition to chlorhexidine twice daily.

D. Postoperative radiographs:

A standardized periapical parallel radiograph will be taken 7 days after implant placement to be analyzed to assess crestal bone level, and after 6 and 9 months after surgery [1].

E. Placement of definitive restoration:

Around 6 months, an implant-level impression coping will be seated on to the implant, and a colored resin will be used to capture the soft tissue emergence profile.

A polyvinyl siloxane (PVS) material will be used to transfer the spatial location of the implant. An implant analog will be placed onto the implant level impression coping, and a gypsum soft tissue hybrid master cast will be created to allow laboratory fabrication of a screw-retained definitive restoration.

A definitive screw-retained zirconia crown will be delivered .

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients in need of extraction of a single, unrestorable tooth in the esthetic zone including maxillary anteriors and premolars
  • Age range between 20-60 years old
  • An intact buccal plate of bone after extraction
  • Medically free patients (Brightman. 1994)
  • Cooperative patients willing to follow up for the duration of the study.

Exclusion Criteria:

  • Acute infection in the implant site
  • Patients incapable of maintaining oral hygiene
  • Pregnant and nursing female patients
  • Smokers (more than 5 cigarettes per day)
  • A habit of bruxism
  • Periodontal disease
  • Subjects who have a systemic disease which affects bone healing as diabetes
  • Use of bone metabolism medicines; (Bisphosphonates) .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control: conventional drilling
Atraumatic extraction followed by osteotomy preparation. Osteotomy site will be prepared using conventional drills. Implant placement will follow.
Procedure: Conventional drilling
Atraumatic extraction, followed by sequential drilling using conventional drills
Active Comparator: Intervention: Osseodensification
Atraumatic extraction followed by osteotomy preparation. Osteotomy site will be prepared using Densah bur. Implant placement will follow.
Procedure: Osseodensification drilling
Atraumatic extraction, followed by osteotomy prepared using densah bur (sequential drilling)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant stability quotient (ISQ)
Time Frame: 1 week, 2 week, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks postoperatively.
resonance frequency analysis
1 week, 2 week, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Crestal bone level
Time Frame: day of the surgery (baseline), at 3 and 6 months postoperatively)
Parallel technique periapical radiography
day of the surgery (baseline), at 3 and 6 months postoperatively)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Omar M Ibrahim, Master, Cairo University
  • Study Chair: Omnia K Tawfik, Lecturer, Cairo University
  • Study Director: Hany El Nahaas, Professor, Cairo Unversity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2024

Primary Completion (Estimated)

December 20, 2025

Study Completion (Estimated)

December 20, 2026

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 16, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11423

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Implant Complication

Clinical Trials on Conventional drilling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe