Crestal Bone ResorptionRCTNCT03250949
Clinical Evaluation Of Dental Implants Stability Placed In Healed Bony Sites Following Over-drilling Compared To Conventional-Drilling Protocol
A study testing implant site over drilling protocol in people with Crestal Bone Resorption and Implant Primary Stability, run by Azhar ALI ELSAYED SELEEM.
Trial summary
Clinical Evaluation Of Dental Implants Stability Placed In Healed Bony Sites Following Over-drilling Compared To Conventional-Drilling Protocol Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Crestal Bone Resorption, Implant Primary Stability, Implant Osseointegration
- What is being tested?
- implant site over drilling protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Sep 2017to May 2018
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who have at least one missing tooth in the upper maxillary arch.
- Patients with healthy systemic condition.(Brightman. 1994)
- Patients aged from 20 to 60 years old.
- Good oral hygiene.(Wiesner et al. 2010)
- Accepts 9 months follow-up period (cooperative patients)
- Patient provides an informed consent.
Who cannot join
- Patients with signs of acute infection related to the area of interest.
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al. 2006).
- Current and former smokers (Lambert, Morris, and Ochi 2000)
- Pregnant women
About this study
Official title: Clinical Evaluation Of Dental Implants Stability Placed In Healed Bony Sites Following Over-drilling Compared To Conventional-Drilling Protocol: A Randomized Controlled Trial.
Clinical Evaluation Of Dental Implants Stability Placed In Healed Bony Sites Following Over-drilling Compared To Conventional-Drilling Protocol
Read the detailed description
- Statement of the problem: peri-implant bone is affected by excessive mechanical stress, the mechanism of bone formation is reduced and the bone resorption is increased, leading to MBL. Isidor F. 2006, Warreth A, 009 A drilling sequence using a drill that is smaller than the implant diameter has been applied as a way to obtain enough initial stability.Bilhan H,2010 However, the implant can be extremely compressed or exceed the torque, which can be higher than the elastic limit of bone when a drill that is smaller than the implant diameter is used. This may affect the bone surrounding the implant and may also lead to a micro fracture.
Frost mentioned that alveolar bone density is changed by micro deformation due to modification of the physical condition. Bone resorption and fibrous tissue production progress if the micro deformation rate is higher than 3,000 micro strain (με). Also, continuous bone replacement occurs while woven bone appears. Wolff J.1986 Bone tissue adapts to the change of stress while minimizing its weight and transforming its structure. Frost HM,1989 The bone formation mechanism is inhibited and the bone resorption mechanism is enhanced if excessive mechanical stress is applied to alveolar bone during implantation, resulting in the progression of marginal bone loss (MBL). Isidor F.2006 , Warreth A,2009-
Rationale for carrying out the trial:
Success and survival rate of an implant are directly associated with primary stability. Friberg B,et al 1991 Primary stability is achieved with initial rigid fixation of implants during the surgery and considered necessary for a successful osseointegration. Sennerby L,et al 1992, Rodrigo D,et al 2010 There are two different processes of bone formation at implant sites; contact and distance osteogenesis. Contact osteogenesis infers new bone formation in direct contact with the implant surface. Distance osteogenesis is the new bone formation on the surfaces of the parent bone and occurs when primary stability is absent at implant site. Davies JE.et al 2003, Sivolella S,et al2012
When there is a gap between the implant surface and bone, a clot will fill the space and will be replaced by a provisional connective matrix that will act as scaffold for formation of woven bone. Berglundh T,et al,2003 , Rossi F,2012 Our study will evaluate the effect of oversized drilling on implant success and secondary stability
- Being tested
- implant site over drilling protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant site over drilling protocolProcedure or surgery
Also called NEO biotech implant system
Osteotomy preparations for the loose fit group will be identical to those of the tight fit group until final drill, which will be 0.2mm wider than the diameter of the implant.
osteotomy site of the implant is wider by 0.2mm than the implant diameter
| Study group | Role | What they receive |
|---|---|---|
| Conventional-Drilling Tight Fit (Control) group | No intervention | osteotomy will be achieved with no. 6 round , then widened , using a drill 1 mm larger than the final drill provided by the manufacturer. the final size of the control osteotomies were same diameter of the implant. |
| Over-drilling Loose Fit (Test) group | Experimental | Osteotomy preparations for the loose fit group will be identical to those of the tight fit group until final drill, which will be 0.2mm wider than the diameter of the implant. Receives: Procedure: implant site over drilling protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant stability
Resonance frequency analysis (RFA) OSSTELL (Osstell Resonance frequency analysis (RFA) (Osstell
Measured: first 3 months
Secondary outcomes (1)
Crestal bone level
by Digital radiography
Measured: from 3 to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study startSep 2017 (estimated)
- Primary completionJan 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crestal Bone ResorptionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azhar ALI ELSAYED SELEEM
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Azhar ALI ELSAYED SELEEM, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250949
- Sponsor's protocol ID
- Randomized Controlled Trial
- Acronym
- RCT
- Status last verified
- Aug 2017
- First submitted
- 10 Aug 2017
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation Of Dental Implants Stability Placed In Healed Bony Sites Following Over-drilling Compared To Conventional-Drilling Protocol: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03250949
- Acronym / sponsor ID
- RCT / Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Azhar ALI ELSAYED SELEEMUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 16 Aug 2017 (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.
Clinical Evaluation Of Dental Implants Stability Placed In Healed Bony Sites Following Over-drilling Compared To Conventional-Drilling Protocol
Detailed description
- Statement of the problem: peri-implant bone is affected by excessive mechanical stress, the mechanism of bone formation is reduced and the bone resorption is increased, leading to MBL. Isidor F. 2006, Warreth A, 009 A drilling sequence using a drill that is smaller than the implant diameter has been applied as a way to obtain enough initial stability.Bilhan H,2010 However, the implant can be extremely compressed or exceed the torque, which can be higher than the elastic limit of bone when a drill that is smaller than the implant diameter is used. This may affect the bone surrounding the implant and may also lead to a micro fracture.
Frost mentioned that alveolar bone density is changed by micro deformation due to modification of the physical condition. Bone resorption and fibrous tissue production progress if the micro deformation rate is higher than 3,000 micro strain (με). Also, continuous bone replacement occurs while woven bone appears. Wolff J.1986 Bone tissue adapts to the change of stress while minimizing its weight and transforming its structure. Frost HM,1989 The bone formation mechanism is inhibited and the bone resorption mechanism is enhanced if excessive mechanical stress is applied to alveolar bone during implantation, resulting in the progression of marginal bone loss (MBL). Isidor F.2006 , Warreth A,2009-
Rationale for carrying out the trial:
Success and survival rate of an implant are directly associated with primary stability. Friberg B,et al 1991 Primary stability is achieved with initial rigid fixation of implants during the surgery and considered necessary for a successful osseointegration. Sennerby L,et al 1992, Rodrigo D,et al 2010 There are two different processes of bone formation at implant sites; contact and distance osteogenesis. Contact osteogenesis infers new bone formation in direct contact with the implant surface. Distance osteogenesis is the new bone formation on the surfaces of the parent bone and occurs when primary stability is absent at implant site. Davies JE.et al 2003, Sivolella S,et al2012
When there is a gap between the implant surface and bone, a clot will fill the space and will be replaced by a provisional connective matrix that will act as scaffold for formation of woven bone. Berglundh T,et al,2003 , Rossi F,2012 Our study will evaluate the effect of oversized drilling on implant success and secondary stability
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional-Drilling Tight Fit (Control) group | No intervention | –osteotomy will be achieved with no. 6 round , then widened , using a drill 1 mm larger than the final drill provided by the manufacturer. the final size of the control osteotomies were same diameter of the implant. |
| Over-drilling Loose Fit (Test) group | Experimental | Procedure: implant site over drilling protocolOsteotomy preparations for the loose fit group will be identical to those of the tight fit group until final drill, which will be 0.2mm wider than the diameter of the implant. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients who have at least one missing tooth in the upper maxillary arch.
- Patients with healthy systemic condition.(Brightman. 1994)
- Patients aged from 20 to 60 years old.
- Good oral hygiene.(Wiesner et al. 2010)
- Accepts 9 months follow-up period (cooperative patients)
Key exclusion criteria (4 listed)
- Patients with signs of acute infection related to the area of interest.
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al. 2006).
- Current and former smokers (Lambert, Morris, and Ochi 2000)
- Pregnant women
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 |
|---|---|---|
| implant site over drilling protocolAlso: NEO biotech implant systemOsteotomy preparations for the loose fit group will be identical to those of the tight fit group until final drill, which will be 0.2mm wider than the diameter of the implant. osteotomy site of the implant is wider by 0.2mm than the implant diameter | Procedure or surgery | Over-drilling Loose Fit (Test) group |
Primary outcome
implant stability
Time frame: first 3 months
Resonance frequency analysis (RFA) OSSTELL (Osstell Resonance frequency analysis (RFA) (Osstell
1 secondary outcome
Crestal bone level
Time frame: from 3 to 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
Related trials for Crestal Bone Resorption
Not yet recruiting
Clinical and Radiographic Evaluation of CGF and Alloplastic Grafting in Participants Undergoing the Socket Shield Technique for Immediate Anterior Maxillary Implant Placement. This Study Assesses Bone Healing and Stability When Managing the Crestal Gap in the Esthetic Zone.
Alveolar Ridge Resorption, Bone Loss in the Esthetic Zone
Enrolling by invitationPhase 1
PRF vs. Graftless Sinus Lift With Implant Placement
Maxillary Sinus Floor Augmentation, Alveolar Bone Loss
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing implant site over drilling protocol in people with Crestal Bone Resorption and Implant Primary Stability, run by Azhar ALI ELSAYED SELEEM.
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 4 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: status not confirmed, as of the sponsor's last update on 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
implant stability (time frame: first 3 months). 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 16 Aug 2017.