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Recruiting NCT06307691

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

No phase Interventional Implant Complication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Conventional drilling, Osseodensification drilling.
Who it may be relevant to
Registry conditions: Implant Complication. Basic parameters: 20 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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 .

Interventions

  • Procedure Conventional drilling
    Atraumatic extraction, followed by sequential drilling using conventional drills
  • Procedure Osseodensification drilling
    Atraumatic extraction, followed by osteotomy prepared using densah bur (sequential drilling)

Primary outcome measures

  • Implant stability quotient (ISQ) [Time frame: 1 week, 2 week, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks postoperatively.]
Secondary outcome measures (1)
  • Crestal bone level [Time frame: day of the surgery (baseline), at 3 and 6 months postoperatively)]

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) .

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Dentistry Cairo University — Cairo

Publications

  • Derks J, Hakansson J, Wennstrom JL, Tomasi C, Larsson M, Berglundh T. Effectiveness of implant therapy analyzed in a Swedish population: early and late implant loss. J Dent Res. 2015 Mar;94(3 Suppl):44S-51S. doi: 10.1177/0022034514563077. Epub 2014 Dec 11. PMID 25503901
  • Adell R, Lekholm U, Rockler B, Branemark PI. A 15-year study of osseointegrated implants in the treatment of the edentulous jaw. Int J Oral Surg. 1981 Dec;10(6):387-416. doi: 10.1016/s0300-9785(81)80077-4. PMID 6809663
  • Schwartz-Arad D, Chaushu G. The ways and wherefores of immediate placement of implants into fresh extraction sites: a literature review. J Periodontol. 1997 Oct;68(10):915-23. doi: 10.1902/jop.1997.68.10.915. PMID 9358358
  • Gelb DA. Immediate implant surgery: three-year retrospective evaluation of 50 consecutive cases. Int J Oral Maxillofac Implants. 1993;8(4):388-99. PMID 8270307
  • Agliardi E, Panigatti S, Clerico M, Villa C, Malo P. Immediate rehabilitation of the edentulous jaws with full fixed prostheses supported by four implants: interim results of a single cohort prospective study. Clin Oral Implants Res. 2010 May;21(5):459-65. doi: 10.1111/j.1600-0501.2009.01852.x. Epub 2010 Jan 22. PMID 20105197
  • Schwartz-Arad D, Grossman Y, Chaushu G. The clinical effectiveness of implants placed immediately into fresh extraction sites of molar teeth. J Periodontol. 2000 May;71(5):839-44. doi: 10.1902/jop.2000.71.5.839. PMID 10872969
  • Marquezan M, Osorio A, Sant'Anna E, Souza MM, Maia L. Does bone mineral density influence the primary stability of dental implants? A systematic review. Clin Oral Implants Res. 2012 Jul;23(7):767-74. doi: 10.1111/j.1600-0501.2011.02228.x. Epub 2011 Jun 2. PMID 21635560
  • Farronato D, Manfredini M, Stocchero M, Caccia M, Azzi L, Farronato M. Influence of Bone Quality, Drilling Protocol, Implant Diameter/Length on Primary Stability: An In Vitro Comparative Study on Insertion Torque and Resonance Frequency Analysis. J Oral Implantol. 2020 Jun 1;46(3):182-189. doi: 10.1563/aaid-joi-D-19-00145. PMID 32582919

Identifiers

NCT: NCT06307691 · 11423

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗