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

NCT ID: NCT06307691

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-06
• Study Completion Date: 2026-12-20

Brief Summary

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.

Detailed Description

Preoperative preparation:

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

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● 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:

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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.

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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 .

Conditions

Implant Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control: conventional drilling

Atraumatic extraction followed by osteotomy preparation. Osteotomy site will be prepared using conventional drills. Implant placement will follow.

Group Type: ACTIVE_COMPARATOR

Conventional drilling

Intervention Type: PROCEDURE

Atraumatic extraction, followed by sequential drilling using conventional drills

Intervention: Osseodensification

Atraumatic extraction followed by osteotomy preparation. Osteotomy site will be prepared using Densah bur. Implant placement will follow.

Group Type: ACTIVE_COMPARATOR

Osseodensification drilling

Intervention Type: PROCEDURE

Atraumatic extraction, followed by osteotomy prepared using densah bur (sequential drilling)

Interventions

Conventional drilling

Atraumatic extraction, followed by sequential drilling using conventional drills

Intervention Type: PROCEDURE

Osseodensification drilling

Atraumatic extraction, followed by osteotomy prepared using densah bur (sequential drilling)

Intervention Type: PROCEDURE

Eligibility Criteria

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) .

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Omar Mostafa Ibrahim Omar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omar M Ibrahim, Master

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Omnia K Tawfik, Lecturer

Role: STUDY_CHAIR

Cairo University

Hany El Nahaas, Professor

Role: STUDY_DIRECTOR

Cairo Unversity

Locations

Faculty of Dentistry Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Omar M Ibrahim, Master

Role: CONTACT

omar_ibrahim@dentistry.cu.edu.eg

010000953710 ext. 002

omnia K tawfik, Lecturer

Role: CONTACT

omnia.tawfik@dentistry.cu.edu.eg

01006002618 ext. 002

Facility Contacts

Omar M Ibrahim, master

Role: primary

omar_ibrahim@dentistry.cu.edu.eg

01000953710 ext. 002

Omnia K Tawfik, PhD

Role: backup

omnia.tawfik@dentistry.cu.edu.eg

01006002618

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Trisi P, Berardini M, Falco A, Podaliri Vulpiani M. New Osseodensification Implant Site Preparation Method to Increase Bone Density in Low-Density Bone: In Vivo Evaluation in Sheep. Implant Dent. 2016 Feb;25(1):24-31. doi: 10.1097/ID.0000000000000358.

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Other Identifiers

11423

Identifier Type: -

Identifier Source: org_study_id