Knife Edge Alveolar RidgeNCT04408781
Management of Narrow Alveolar Ridges Via Densah-bur Versus Piezoelectric
A study testing Ridge expansion by osseodensifcation/Ridge expansion by ridge splitting in people with Knife Edge Alveolar Ridge, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of the present study is to evaluate Clinical \& radiographic evaluation of split-crest ridge technique versus osseodensification technique for dental implant placement into narrow alveolar Ridge. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Knife Edge Alveolar Ridge
- What is being tested?
- Ridge expansion by osseodensifcation/Ridge expansion by ridge splitting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult
Who may be able to join
- Patients with missing tooth which is needed for replacement.
- Patients having a Bucco-lingual/palatal width of the edentulous alveolar ridge less than 6 mm. with a minimum of 3mm. residual bone width.
- Patients having at least 11 mm residual bone height at the proposed edentulous area.
- The recipient bed of the implant should be free from any pathological conditions.
- No history of diagnosed bone disease or medication known to affect bone metabolism.
- Patients who are cooperative, motivated, and has good oral hygiene.
Who cannot join
- Patients incapable to undergoing minor oral surgical procedures.
- Patients with insuf}cient vertical inter-arch space, upon centric occlusion, to accommodate the available restorative components.
- Patients who have any systemic condition that may contraindicate implant therapy.
- Patients with modifying habits affecting osteointegration for example, smoking and alcoholism.
- Patients with parafunctional habits that can overload the implant, such as bruxism and clenching.
- Patients with impractical expectations about the esthetic outcome of implant therapy.
Show all 9Show fewer
- Patients in the growth stage with mixed dentition.
- Patients with a history of drug abuse.
- Patients with a history of psychiatric disorder. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical & Radiographic Evaluation of Split-crest Ridge Technique Versus Osseodensification Technique for Dental Implant Placement Into Narrow Alveolar Ridge
The aim of the present study is to evaluate Clinical \& radiographic evaluation of split-crest ridge technique versus osseodensification technique for dental implant placement into narrow alveolar Ridge.
Read the detailed description
The aim of the study is to evaluate ridge width gain in patients with narrow alveolar ridges followingc osseodensification as compared to ridge splitting with simultaneous implant placement using CBCT.
Interventions: I. Pre-operative phase: Clinical Examination: 1. Visual examination, palpation and inspection of the entire oral and Para-oral tissues. 2. Preoperative alginate impressions for both the maxillary and the mandibular Ridges. 3. Full mouth scaling and root planing, followed by oral hygiene instructions. 4. The Bucco-Lingual/Palatal alveolar ridge width measurement at site of interest using a bone caliper. 5. Study casts will be made in order to properly evaluate the inter-arch space, occlusion type and direction of forces in regard to the site of the future implant. Radiographic Examination: 1. A panoramic radiograph for screening purposes: - estimating the residual bone height. - Verify the absence of any pathology in the bone. 2. Cone beam computed Tomography (CBCT) for Diagnostic purposes: - Detect the Bucco-lingual/palatal alveolar ridge width and height at the site of interest. - Detect approximation to any anatomical boundaries (e.g.mental foramen, maxillary sinus floor.) -Detect bone type. II. Surgical phase: All procedures will be done under strictly aseptic conditions 1. Patients will be anesthetized at the surgical site by the appropriate method using Articaine Hydrochloride 4%. 2. At the site a horizontal incision will be created, extending the entire length of the edentulous area, extending one tooth mesial and distal. Anterior and/or posterior vertical releasing incision will be made as needed. 3. Full thickness mucoperiosteal ~ap will be raised with complete exposure of the alveolar bone. 4. Bone width will be recon}rmed intrasurgically using a bone caliper. Measurements will be taken at around 1 mm below the crestal margin, to the nearest 0.5mm. Alveolar ridge width measurements will be repeated at second stage surgery. 5. A.For the intervention: 1. Drilling f bone will commence using the Pilot Drill to the desired depth (Drill speed 800-1500 rpm with copious irrigation). 2. Osseodensification drilling will begin with the narrowest Densah Bur. (Counterclockwise drill speed 800-1500 rpm with copious irrigation). If when running the bur into the osteotomy a feeling of haptic feedback of pushing up and out of the osteotomy, repetitively lifting off and reapplying pressure with a pumping motion will be applied until the desired depth is reached. 3. Densah Burs will be used sequentially in small increments. As the bur diameter increases, the bone will slowly expand to the final diameter. 4. The osteotomy final preparation diameter would be an average diameter that measures 0.5-0.8 mm smaller than the implant average diameter in soft bone, and In hard bone, diameter that measures 0.2-0.5 mm smaller than the implant average diameter. 5. Implant placement using the drill motor initially, then Finishing placement of the implant to depth with a torque-indicating wrench. 6. If < 1mm of buccal bone thickness has resulted after osseodensification, bone grafting post implant placement and complete implant coverage will be considered 5.B.For the control: 1. A bone crestal incision will be created, using the piezo-electric surgical tips. The cut will be done through the cortical bone to reach the trabecular bone. 2. One/two vertical cuts will be created by piezo-drill as needed connecting, to the crestal cut. 3. Conventional Drills will be used for osteotomy preparation by wedging it between the two plates of bone. 4. The implant with the proper length and diameter will be gradually engaged to separate the buccal and Lingual/palatal bone until full seating is achieved. 6. Cover screws will be placed on the implants. 7.Closure of the ~ap will be done by interrupted sutures using 4-0 resorbable suture materials. III. Post-operative phase: Post-operative instructions and medication: Patient is recommended to: 1. Maintain a soft diet to avoid trauma to the surgical site. 2. Place a cold compress super}cially on the skin overlying the surgical site immediately. Apply for 30 minutes, then off for 20-30 minutes. This should be done on a near continuous basis (or as much as possible) for the }first 48 hours. 3. Maintain Oral hygiene but avoid surgical site for the }rst 4 days after surgery. 4. Medications (Ferrigno et al. 2005)( Garcez-Filho et al.2015) • Augmentin* (1g tablets) will be prescribed twice daily for 5 days to avoid possibility of infection. • Ibuprofen 600mg four times daily for one week. • Voltarene* (75 mg injection I.M.) will be used in case of severe pain, as a rescue. • Hexitol** 0.12% chlorhexidine mouth rinse for 2 weeks. 5. Sutures will be removed after 2 weeks 6. Final restoration will be completed after 6 months - Augmentin 1g. Medical union pharmaceuticals co. Abu Sultan, Ismailia, Egypt. BRUFEN 600 (Ibuprofen 600 mg). Kahira Pharm. \& Chem. Ind. Co., Under licence from: Abbott Laboratories. - Voltarene® 75mg/3ml (IM). Diclofenac natrium. NOVARTIS PHARMA. S.A.E. - Hexitol Chlorhexidine Hcl 125 mg / 100 ml. Arab Drug Company (ADCO).
- Conditions
- Knife Edge Alveolar Ridge
- Being tested
- Ridge expansion by osseodensifcation/Ridge expansion by ridge splitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ridge expansion by osseodensifcation/Ridge expansion by ridge splittingProcedure or surgery
Also called Ridge expansion by ridge splitting
Ridge expansion by ridge splitting using the piezotome in conjunction with simultaneous implant placement in narrow ridges.
| Study group | Role | What they receive |
|---|---|---|
| Ridge expansion by osseodensifcation | Experimental | Ridge expansion and osteotomy drilling by osseodensifcation in conjunction with simultaneous implant placement in narrow ridges Receives: Procedure: Ridge expansion by osseodensifcation/Ridge expansion by ridge splitting |
| Ridge expansion by ridge splitting | Active comparator | Ridge expansion by ridge splitting using the piezotome in conjunction with simultaneous implant placement in narrow ridges. Receives: Procedure: Ridge expansion by osseodensifcation/Ridge expansion by ridge splitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone width
Cone beam computed tomography
Measured: Baseline and six month post surgically
Secondary outcomes (1)
Change in Implant stability
osstell
Measured: Baseline and six month post surgically
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 Feb 2018
- Primary completion15 Jan 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knife Edge Alveolar RidgeStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abd el-Nabi Mohamed Amin Bilal, Al-Azhar University
- Investigators
- Ahmed abd El-Nabi Bilal, MSC, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408781
- Sponsor's protocol ID
- 104
- Status last verified
- Feb 2021
- First submitted
- 26 May 2020
- Last updated
- 15 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical & Radiographic Evaluation of Split-crest Ridge Technique Versus Osseodensification Technique for Dental Implant Placement Into Narrow Alveolar Ridge
- ClinicalTrials.gov ID
- NCT04408781
- Acronym / sponsor ID
- 104
- Conditions
- Knife Edge Alveolar Ridge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 29 May 2020 (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.
The aim of the present study is to evaluate Clinical \& radiographic evaluation of split-crest ridge technique versus osseodensification technique for dental implant placement into narrow alveolar Ridge.
Detailed description
The aim of the study is to evaluate ridge width gain in patients with narrow alveolar ridges followingc osseodensification as compared to ridge splitting with simultaneous implant placement using CBCT.
Interventions: I. Pre-operative phase: Clinical Examination: 1. Visual examination, palpation and inspection of the entire oral and Para-oral tissues. 2. Preoperative alginate impressions for both the maxillary and the mandibular Ridges. 3. Full mouth scaling and root planing, followed by oral hygiene instructions. 4. The Bucco-Lingual/Palatal alveolar ridge width measurement at site of interest using a bone caliper. 5. Study casts will be made in order to properly evaluate the inter-arch space, occlusion type and direction of forces in regard to the site of the future implant. Radiographic Examination: 1. A panoramic radiograph for screening purposes: - estimating the residual bone height. - Verify the absence of any pathology in the bone. 2. Cone beam computed Tomography (CBCT) for Diagnostic purposes: - Detect the Bucco-lingual/palatal alveolar ridge width and height at the site of interest. - Detect approximation to any anatomical boundaries (e.g.mental foramen, maxillary sinus floor.) -Detect bone type. II. Surgical phase: All procedures will be done under strictly aseptic conditions 1. Patients will be anesthetized at the surgical site by the appropriate method using Articaine Hydrochloride 4%. 2. At the site a horizontal incision will be created, extending the entire length of the edentulous area, extending one tooth mesial and distal. Anterior and/or posterior vertical releasing incision will be made as needed. 3. Full thickness mucoperiosteal ~ap will be raised with complete exposure of the alveolar bone. 4. Bone width will be recon}rmed intrasurgically using a bone caliper. Measurements will be taken at around 1 mm below the crestal margin, to the nearest 0.5mm. Alveolar ridge width measurements will be repeated at second stage surgery. 5. A.For the intervention: 1. Drilling f bone will commence using the Pilot Drill to the desired depth (Drill speed 800-1500 rpm with copious irrigation). 2. Osseodensification drilling will begin with the narrowest Densah Bur. (Counterclockwise drill speed 800-1500 rpm with copious irrigation). If when running the bur into the osteotomy a feeling of haptic feedback of pushing up and out of the osteotomy, repetitively lifting off and reapplying pressure with a pumping motion will be applied until the desired depth is reached. 3. Densah Burs will be used sequentially in small increments. As the bur diameter increases, the bone will slowly expand to the final diameter. 4. The osteotomy final preparation diameter would be an average diameter that measures 0.5-0.8 mm smaller than the implant average diameter in soft bone, and In hard bone, diameter that measures 0.2-0.5 mm smaller than the implant average diameter. 5. Implant placement using the drill motor initially, then Finishing placement of the implant to depth with a torque-indicating wrench. 6. If < 1mm of buccal bone thickness has resulted after osseodensification, bone grafting post implant placement and complete implant coverage will be considered 5.B.For the control: 1. A bone crestal incision will be created, using the piezo-electric surgical tips. The cut will be done through the cortical bone to reach the trabecular bone. 2. One/two vertical cuts will be created by piezo-drill as needed connecting, to the crestal cut. 3. Conventional Drills will be used for osteotomy preparation by wedging it between the two plates of bone. 4. The implant with the proper length and diameter will be gradually engaged to separate the buccal and Lingual/palatal bone until full seating is achieved. 6. Cover screws will be placed on the implants. 7.Closure of the ~ap will be done by interrupted sutures using 4-0 resorbable suture materials. III. Post-operative phase: Post-operative instructions and medication: Patient is recommended to: 1. Maintain a soft diet to avoid trauma to the surgical site. 2. Place a cold compress super}cially on the skin overlying the surgical site immediately. Apply for 30 minutes, then off for 20-30 minutes. This should be done on a near continuous basis (or as much as possible) for the }first 48 hours. 3. Maintain Oral hygiene but avoid surgical site for the }rst 4 days after surgery. 4. Medications (Ferrigno et al. 2005)( Garcez-Filho et al.2015) • Augmentin* (1g tablets) will be prescribed twice daily for 5 days to avoid possibility of infection. • Ibuprofen 600mg four times daily for one week. • Voltarene* (75 mg injection I.M.) will be used in case of severe pain, as a rescue. • Hexitol** 0.12% chlorhexidine mouth rinse for 2 weeks. 5. Sutures will be removed after 2 weeks 6. Final restoration will be completed after 6 months - Augmentin 1g. Medical union pharmaceuticals co. Abu Sultan, Ismailia, Egypt. BRUFEN 600 (Ibuprofen 600 mg). Kahira Pharm. \& Chem. Ind. Co., Under licence from: Abbott Laboratories. - Voltarene® 75mg/3ml (IM). Diclofenac natrium. NOVARTIS PHARMA. S.A.E. - Hexitol Chlorhexidine Hcl 125 mg / 100 ml. Arab Drug Company (ADCO).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ridge expansion by osseodensifcation | Experimental | Procedure: Ridge expansion by osseodensifcation/Ridge expansion by ridge splittingRidge expansion and osteotomy drilling by osseodensifcation in conjunction with simultaneous implant placement in narrow ridges |
| Ridge expansion by ridge splitting | Active comparator | Procedure: Ridge expansion by osseodensifcation/Ridge expansion by ridge splittingRidge expansion by ridge splitting using the piezotome in conjunction with simultaneous implant placement in narrow ridges. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with missing tooth which is needed for replacement.
- Patients having a Bucco-lingual/palatal width of the edentulous alveolar ridge less than 6 mm. with a minimum of 3mm. residual bone width.
- Patients having at least 11 mm residual bone height at the proposed edentulous area.
- The recipient bed of the implant should be free from any pathological conditions.
- No history of diagnosed bone disease or medication known to affect bone metabolism.
Key exclusion criteria (9 listed)
- Patients incapable to undergoing minor oral surgical procedures.
- Patients with insuf}cient vertical inter-arch space, upon centric occlusion, to accommodate the available restorative components.
- Patients who have any systemic condition that may contraindicate implant therapy.
- Patients with modifying habits affecting osteointegration for example, smoking and alcoholism.
- Patients with parafunctional habits that can overload the implant, such as bruxism and clenching.
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 |
|---|---|---|
| Ridge expansion by osseodensifcation/Ridge expansion by ridge splittingAlso: Ridge expansion by ridge splittingRidge expansion by ridge splitting using the piezotome in conjunction with simultaneous implant placement in narrow ridges. | Procedure or surgery | Ridge expansion by osseodensifcation, Ridge expansion by ridge splitting |
Primary outcome
Change in bone width
Time frame: Baseline and six month post surgically
Cone beam computed tomography
1 secondary outcome
Change in Implant stability
Time frame: Baseline and six month post surgically
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Ahmed abd El-Nabi Bilal, MSC principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ridge expansion by osseodensifcation/Ridge expansion by ridge splitting in people with Knife Edge Alveolar Ridge, run by Al-Azhar 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 15 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bone width (time frame: Baseline and six month post surgically). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2021.