Implant ComplicationNCT06307691
Clinical and Radiographic Evaluation of Immediate Implant Placement Using Osseodensification Versus Traditional Drilling Protocol
A study testing Conventional drilling and Osseodensification drilling in people with Implant Complication, run by Cairo University at 1 site in Egypt.
Trial 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… 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?
- Conventional drilling and Osseodensification drilling
- 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
- 6 Mar 2024to 20 Dec 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 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.
Who cannot join
- 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) .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry Cairo University
Cairo
Omar M Ibrahim, master, 01000953710 ext. 002, omar_ibrahim@dentistry.cu.edu.eg
Omnia K Tawfik, PhD, 01006002618, omnia.tawfik@dentistry.cu.edu.eg
About this study
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.
Read the 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:
- Restorability of the tooth.
- Relation to adjacent teeth and the available mesio-distal space.
- 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:
- Bucco-lingual width of bone (measured 1 mm below the alveolar crest).
- Mesio-distal width of bone.
- Corono-apical height of bone.
- Presence of labial undercut, dehiscence or fenestration.
- Relation to vital structures as nasal floor and maxillary sinus.
- Relation to adjacent teeth.
- Surgical Procedure: <!-- -->
- 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.
- 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
- 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.
- 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.
- A healing collar will be placed over the implant to allow the implant healing to be monitored during the early phase of healing.
- Postoperative care:
Administration of:
- Antibiotics (Amoxicillin 500 mg orally four times daily for 5 days).
- Anti-inflammatory drugs (NSAIDS; Ibuprofen 600mg three times daily for 3 days then whenever needed).
- 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.
- 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].
- 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
- Being tested
- Conventional drilling, Osseodensification drilling
- Keywords
- Implant stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional drillingProcedure or surgery
Atraumatic extraction, followed by sequential drilling using conventional drills
Osseodensification drillingProcedure or surgery
Atraumatic extraction, followed by osteotomy prepared using densah bur (sequential drilling)
| Study group | Role | What they receive |
|---|---|---|
| Control: conventional drilling | Active comparator | Atraumatic extraction followed by osteotomy preparation. Osteotomy site will be prepared using conventional drills. Implant placement will follow. Receives: Procedure: Conventional drilling |
| Intervention: Osseodensification | Active comparator | Atraumatic extraction followed by osteotomy preparation. Osteotomy site will be prepared using Densah bur. Implant placement will follow. Receives: Procedure: Osseodensification drilling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability quotient (ISQ)
resonance frequency analysis
Measured: 1 week, 2 week, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks postoperatively.
Secondary outcomes (1)
Crestal bone level
Parallel technique periapical radiography
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.
- First posted13 Mar 2024
- Study start6 Mar 2024
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Implant ComplicationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Mostafa Ibrahim Omar, Cairo University
- Investigators
- Omar M Ibrahim, Master, Principal investigator, Cairo UniversityOmnia K Tawfik, Lecturer, Study chair, Cairo UniversityHany El Nahaas, Professor, Study director, Cairo Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307691
- Sponsor's protocol ID
- 11423
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 25503901Adell 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.
PubMed 6809663Schwartz-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.
PubMed 9358358Gelb DA. Immediate implant surgery: three-year retrospective evaluation of 50 consecutive cases. Int J Oral Maxillofac Implants. 1993;8(4):388-99.
PubMed 8270307Agliardi 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.
PubMed 20105197Schwartz-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.
PubMed 10872969Marquezan 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.
PubMed 21635560Farronato 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.
PubMed 32582919Greenstein G, Cavallaro J. Implant Insertion Torque: Its Role in Achieving Primary Stability of Restorable Dental Implants. Compend Contin Educ Dent. 2017 Feb;38(2):88-95; quiz 96.
PubMed 28156122Trisi 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.
PubMed 26584202Boustany CM, Reed H, Cunningham G, Richards M, Kanawati A. Effect of a modified stepped osteotomy on the primary stability of dental implants in low-density bone: a cadaver study. Int J Oral Maxillofac Implants. 2015 Jan-Feb;30(1):48-55. doi: 10.11607/jomi.3720.
PubMed 25615915Huwais S, Meyer EG. A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):27-36. doi: 10.11607/jomi.4817. Epub 2016 Oct 14.
PubMed 27741329
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Immediate Implant Placement Using Osseodensification Versus Traditional Drilling Protocol
- ClinicalTrials.gov ID
- NCT06307691
- Acronym / sponsor ID
- 11423
- Conditions
- Implant Complication
- Keywords
- Implant stability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Restorability of the tooth.
- Relation to adjacent teeth and the available mesio-distal space.
- 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:
- Bucco-lingual width of bone (measured 1 mm below the alveolar crest).
- Mesio-distal width of bone.
- Corono-apical height of bone.
- Presence of labial undercut, dehiscence or fenestration.
- Relation to vital structures as nasal floor and maxillary sinus.
- Relation to adjacent teeth.
- Surgical Procedure: <!-- -->
- 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.
- 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
- 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.
- 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.
- A healing collar will be placed over the implant to allow the implant healing to be monitored during the early phase of healing.
- Postoperative care:
Administration of:
- Antibiotics (Amoxicillin 500 mg orally four times daily for 5 days).
- Anti-inflammatory drugs (NSAIDS; Ibuprofen 600mg three times daily for 3 days then whenever needed).
- 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.
- 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].
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control: conventional drilling | Active comparator | Procedure: Conventional drillingAtraumatic extraction followed by osteotomy preparation. Osteotomy site will be prepared using conventional drills. Implant placement will follow. |
| Intervention: Osseodensification | Active comparator | Procedure: Osseodensification drillingAtraumatic extraction followed by osteotomy preparation. Osteotomy site will be prepared using Densah bur. Implant placement will follow. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional drillingAtraumatic extraction, followed by sequential drilling using conventional drills | Procedure or surgery | Control: conventional drilling |
| Osseodensification drillingAtraumatic extraction, followed by osteotomy prepared using densah bur (sequential drilling) | Procedure or surgery | Intervention: Osseodensification |
Primary outcome
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 secondary outcome
Crestal bone level
Time frame: day of the surgery (baseline), at 3 and 6 months postoperatively)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Background: PubMed 25503901Derks 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.
- Background: PubMed 6809663Adell 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.
- Background: PubMed 9358358Schwartz-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.
- Background: PubMed 8270307Gelb DA. Immediate implant surgery: three-year retrospective evaluation of 50 consecutive cases. Int J Oral Maxillofac Implants. 1993;8(4):388-99.
- Background: PubMed 20105197Agliardi 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.
- Background: PubMed 10872969Schwartz-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.
- Background: PubMed 21635560Marquezan 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.
- Background: PubMed 32582919Farronato 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.
- Background: PubMed 28156122Greenstein G, Cavallaro J. Implant Insertion Torque: Its Role in Achieving Primary Stability of Restorable Dental Implants. Compend Contin Educ Dent. 2017 Feb;38(2):88-95; quiz 96.
- Background: PubMed 26584202Trisi 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.
- Background: PubMed 25615915Boustany CM, Reed H, Cunningham G, Richards M, Kanawati A. Effect of a modified stepped osteotomy on the primary stability of dental implants in low-density bone: a cadaver study. Int J Oral Maxillofac Implants. 2015 Jan-Feb;30(1):48-55. doi: 10.11607/jomi.3720.
- Background: PubMed 27741329Huwais S, Meyer EG. A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):27-36. doi: 10.11607/jomi.4817. Epub 2016 Oct 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Omar M Ibrahim, Master principal investigator
Cairo University
Omnia K Tawfik, Lecturer study chair
Cairo University
Hany El Nahaas, Professor study director
Cairo Unversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional drilling and Osseodensification drilling 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 19 Mar 2024. 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?
Contact Omar M Ibrahim, Master (010000953710 ext. 002, omar_ibrahim@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant stability quotient (ISQ) (time frame: 1 week, 2 week, 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 NCT06307691, which also lists 12 linked publications.
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 19 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.