Mandible SmallRCTNCT04017117
Augmentation of Atrophic Mandibule Using Poly Ether Ether Ketone Mesh
A study testing under local anasthesia,Ridge Augmention of posterior atrophic mandible by using mix of autogenous bone graft and bone substitutes is used under PEEK mesh in people with Mandible Small, run by Cairo University at 1 site in Egypt.
Trial summary
Comparative study between custom-made polyether ether ketone and titanium mesh for augmentation of atrophic posterior mandible. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Mandible Small
- What is being tested?
- under local anasthesia,Ridge Augmention of posterior atrophic mandible by using mix of autogenous bone graft and bone substitutes is used under PEEK mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jun 2019to 1 Dec 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with atrophic posterior mandible
- Both sexes
- No intraoral soft and hard tissue pathology
- No systemic condition that contraindicate implant placement
Who cannot join
- Untreated gingivitis, periodontitis
- Insufficient oral hygiene
- Previous radiation therapy the head and neck neoplasia, or bone augmentation to implant site.
- Systemic disorders
- Heavy smoking more than 20 cigarettes per day
- Bone pathology
Show all 9Show fewer
- Psychiatric problems
- Emotional instability
- Unrealistic aesthetic demands
Trial locations and contacts
1 site in 1 country.
Adham Y Zakaria, Master contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty Of Dental and Oral Medicine-Cairo University
Cairo
Adham Y Zakaria, Master, 00201226000564, amira_5queens@hotmail.com
Adham Y Zakaria, Master, 00201226000741, amira_5queens@hotmail.com
About this study
Official title: Comparative Study Between Custom-made Polyether Ether Ketone and Titanium Mesh for Augmentation of Atrophic Posterior Mandible. Randomized Clinical Trial
Comparative study between custom-made polyether ether ketone and titanium mesh for augmentation of atrophic posterior mandible.
Read the detailed description
Designing and manufacturing
- The CBCT images of the patient will be used to build a digital model using a 3D planning software (Mimics innovation suite). Based on this model, a machine will be used to mill a pressed and pre-sintered body of PEEK to the desired macroscopic shape.
- The size of the machined sheet is enlarged in order to compensate for the sintering shrinkage performed at 1450 C.
- After manufacturing, the sheet will be cleaned in an ultrasonic bath of 70% alcohol for 15 min, followed by a brief heating to 1200 C.
- It will be again cleaned in an ultrasonic bath for 3x15 min using 90% alcohol.
- Thereafter the sheet was placed in an autoclave and sterilized using a standard program.
- The sheets will have a thickness of approximately 0.5 - 0.7 mm. b. Surgery
- The intraoral area is initially cleaned with chlorhexidine 1 mg/ml.
- Local anesthesia is administered.
- Horizontal crestal incisions are made lingual of the mid-crest within the keratinized tissue. Vertical releasing incisions are placed on the buccal aspect of the surgical site in the usual manner to provide adequate access and to allow for eventual coronal repositioning.
- Then, a full-thickness mucoperiosteal flap is reflected to completely expose the atrophic ridge.
- The cortex of the mandibular crest is generously perforated to produce bleeding in multiple sites. The pilot holes for the fixation screws were also prepared at this time.
- The barrier is inserted over the mandible and compressed into place, the fixation screws are inserted and no adaptation will be needed as the barrier is custom-made for the edentulous ridge.
- The ceramic sheets is cleaned with 3% hydrogen peroxide prior to soft tissue closure.
- After fixation of the sheets, the buccal flaps should be coronally repositioned.
- Split-thickness periosteal releasing incisions are completed to aid in primary tension-free closure. The flap margins are then advanced over the barrier and approximated to evaluate for tension-free closure.
- After a mean of 6 months of uneventful healing, the augmented sites are reopened. The ceramic barrier and fixation screws are identified and removed, followed by Dental implant.
Post-operative care:
Avoid traumatization of the surgical site. Patients must abstain from brushing at the surgical area. Instead, a disinfecting mouth rinse should be used (e.g. chlorhexidine 0.2%).
Instruct the patient not to touch or manipulate the surgical area. Ice packs for 10 minutes every 30 minutes for 24 hours. Do not use removable dentures during the expansion phase. Temporary fixed partial dentures must be adjusted to the expected tissue gain.
No consume of tobacco
Post-operative medications will be prescribed as follows:
Amoxicillin/clavulanic acid tablets 10mg/kg every 12 hours for 7 days, diclofenac potassium 50mg every 8 hours for 4 days and then as needed, metronidazole 5 mg/kg every 8 hours for 7 days and chlorhexidine gluconate 0.1% mouthwash 3 times daily for 14 days.
11b. Criteria for discontinuing or modifying intervention: No protocol for discontinuation of the procedure. 11c. Strategies to improve adherence to intervention: Face to face adherence reminder session will take place to stress on the post-operative instructions at the following time intervals.
Patients were recalled every other day to monitor soft tissue healing for the first week, one visit weekly for the first month then monthly for 6 months.
- Conditions
- Mandible Small
- Being tested
- under local anasthesia,Ridge Augmention of posterior atrophic mandible by using mix of autogenous bone graft and bone substitutes is used under PEEK mesh
- Medical subject headings
- Micrognathism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
under local anasthesia,Ridge Augmention of posterior atrophic mandible by using mix of autogenous bone graft and bone substitutes is used under PEEK meshProcedure or surgery
comparing between PEEK mesh and Titanium mesh for augmentation of posterior atrophic mandible using mix of autogenous bone graft and bone substitute.
| Study group | Role | What they receive |
|---|---|---|
| Custom Made Poly Ether Ether Ketone Mesh | Experimental | Applying Poly Ether Ether Ketone mesh with mix of autogenous bone graft and bone substitute in posterior atrophic mandible for augmentation Receives: Procedure: under local anasthesia,Ridge Augmention of posterior atrophic mandible by using mix of autogenous bone graft and bone substitutes is used under PEEK mesh |
| Conventional Titanium mesh | Active comparator | Applying Titanium mesh with mix of autogenous bone graft and bone substitute in posterior atrophic mandible for augmentation Receives: Procedure: under local anasthesia,Ridge Augmention of posterior atrophic mandible by using mix of autogenous bone graft and bone substitutes is used under PEEK mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical amount of bone increased (length in millimeters). horizontal amount f bone increased after augmentation (width in millimeters).
Length (Vertical Augmentation) Width (horizontal augmentation) gained after augmentation of atrophic mandible in millimeters using cone beam computed tomography (measuring tool) measurment tools : with the aid of cone beam computed tomography
Measured: 6 months
Secondary outcomes (1)
Rate of Soft Tissue Dehiscence
which mesh will cause soft tissue dehiscence more.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start25 Jun 2019
- Primary completion25 Nov 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mandible SmallStudies 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
- Model description
- A Randomized Clinical Trial. A trial will be carried out in hospital of Oral and Maxillofacial surgery department,Faculty of Oral and Dental Medicine Cairo University Equal randomization parallel group study positive controlled
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adham Zakaria, Cairo University
- Investigators
- Mohamed F Shehab, PHD, Study director, Professor of Oral and Maxillofacial Surgery - Cairo University.Khaled A Salaheddin, PHD, Study director, Lecturer of Oral and Maxillofacial Surgery - Cairo University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017117
- Sponsor's protocol ID
- CEBD-CU-2019-06-19
- Acronym
- RCT
- Status last verified
- Jul 2022
- First submitted
- 25 Jun 2019
- Last updated
- 20 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Misch CM. Bone augmentation of the atrophic posterior mandible for dental implants using rhBMP-2 and titanium mesh: clinical technique and early results. Int J Periodontics Restorative Dent. 2011 Nov-Dec;31(6):581-9.
PubMed 22140660Her S, Kang T, Fien MJ. Titanium mesh as an alternative to a membrane for ridge augmentation. J Oral Maxillofac Surg. 2012 Apr;70(4):803-10. doi: 10.1016/j.joms.2011.11.017. Epub 2012 Jan 28.
PubMed 22285340Pieri F, Corinaldesi G, Fini M, Aldini NN, Giardino R, Marchetti C. Alveolar ridge augmentation with titanium mesh and a combination of autogenous bone and anorganic bovine bone: a 2-year prospective study. J Periodontol. 2008 Nov;79(11):2093-103. doi: 10.1902/jop.2008.080061.
PubMed 18980518
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Custom-made Polyether Ether Ketone and Titanium Mesh for Augmentation of Atrophic Posterior Mandible. Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04017117
- Acronym / sponsor ID
- RCT / CEBD-CU-2019-06-19
- Conditions
- Mandible Small
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 25 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 12 Jul 2019 (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.
Comparative study between custom-made polyether ether ketone and titanium mesh for augmentation of atrophic posterior mandible.
Detailed description
Designing and manufacturing
- The CBCT images of the patient will be used to build a digital model using a 3D planning software (Mimics innovation suite). Based on this model, a machine will be used to mill a pressed and pre-sintered body of PEEK to the desired macroscopic shape.
- The size of the machined sheet is enlarged in order to compensate for the sintering shrinkage performed at 1450 C.
- After manufacturing, the sheet will be cleaned in an ultrasonic bath of 70% alcohol for 15 min, followed by a brief heating to 1200 C.
- It will be again cleaned in an ultrasonic bath for 3x15 min using 90% alcohol.
- Thereafter the sheet was placed in an autoclave and sterilized using a standard program.
- The sheets will have a thickness of approximately 0.5 - 0.7 mm. b. Surgery
- The intraoral area is initially cleaned with chlorhexidine 1 mg/ml.
- Local anesthesia is administered.
- Horizontal crestal incisions are made lingual of the mid-crest within the keratinized tissue. Vertical releasing incisions are placed on the buccal aspect of the surgical site in the usual manner to provide adequate access and to allow for eventual coronal repositioning.
- Then, a full-thickness mucoperiosteal flap is reflected to completely expose the atrophic ridge.
- The cortex of the mandibular crest is generously perforated to produce bleeding in multiple sites. The pilot holes for the fixation screws were also prepared at this time.
- The barrier is inserted over the mandible and compressed into place, the fixation screws are inserted and no adaptation will be needed as the barrier is custom-made for the edentulous ridge.
- The ceramic sheets is cleaned with 3% hydrogen peroxide prior to soft tissue closure.
- After fixation of the sheets, the buccal flaps should be coronally repositioned.
- Split-thickness periosteal releasing incisions are completed to aid in primary tension-free closure. The flap margins are then advanced over the barrier and approximated to evaluate for tension-free closure.
- After a mean of 6 months of uneventful healing, the augmented sites are reopened. The ceramic barrier and fixation screws are identified and removed, followed by Dental implant.
Post-operative care:
Avoid traumatization of the surgical site. Patients must abstain from brushing at the surgical area. Instead, a disinfecting mouth rinse should be used (e.g. chlorhexidine 0.2%).
Instruct the patient not to touch or manipulate the surgical area. Ice packs for 10 minutes every 30 minutes for 24 hours. Do not use removable dentures during the expansion phase. Temporary fixed partial dentures must be adjusted to the expected tissue gain.
No consume of tobacco
Post-operative medications will be prescribed as follows:
Amoxicillin/clavulanic acid tablets 10mg/kg every 12 hours for 7 days, diclofenac potassium 50mg every 8 hours for 4 days and then as needed, metronidazole 5 mg/kg every 8 hours for 7 days and chlorhexidine gluconate 0.1% mouthwash 3 times daily for 14 days.
11b. Criteria for discontinuing or modifying intervention: No protocol for discontinuation of the procedure. 11c. Strategies to improve adherence to intervention: Face to face adherence reminder session will take place to stress on the post-operative instructions at the following time intervals.
Patients were recalled every other day to monitor soft tissue healing for the first week, one visit weekly for the first month then monthly for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Randomized Clinical Trial. A trial will be carried out in hospital of Oral and Maxillofacial surgery department,Faculty of Oral and Dental Medicine Cairo University Equal randomization parallel group study positive controlled
| Arm | Type | Receives |
|---|---|---|
| Custom Made Poly Ether Ether Ketone Mesh | Experimental | Procedure: under local anasthesia,Ridge Augmention of posterior atrophic mandible by using mix of autogenous bone graft and bone substitutes is used under PEEK meshApplying Poly Ether Ether Ketone mesh with mix of autogenous bone graft and bone substitute in posterior atrophic mandible for augmentation |
| Conventional Titanium mesh | Active comparator | Procedure: under local anasthesia,Ridge Augmention of posterior atrophic mandible by using mix of autogenous bone graft and bone substitutes is used under PEEK meshApplying Titanium mesh with mix of autogenous bone graft and bone substitute in posterior atrophic mandible for augmentation |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with atrophic posterior mandible
- Both sexes
- No intraoral soft and hard tissue pathology
- No systemic condition that contraindicate implant placement
Key exclusion criteria (9 listed)
- Untreated gingivitis, periodontitis
- Insufficient oral hygiene
- Previous radiation therapy the head and neck neoplasia, or bone augmentation to implant site.
- Systemic disorders
- Heavy smoking more than 20 cigarettes per day
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 |
|---|---|---|
| under local anasthesia,Ridge Augmention of posterior atrophic mandible by using mix of autogenous bone graft and bone substitutes is used under PEEK meshcomparing between PEEK mesh and Titanium mesh for augmentation of posterior atrophic mandible using mix of autogenous bone graft and bone substitute. | Procedure or surgery | Conventional Titanium mesh, Custom Made Poly Ether Ether Ketone Mesh |
Primary outcome
Vertical amount of bone increased (length in millimeters). horizontal amount f bone increased after augmentation (width in millimeters).
Time frame: 6 months
Length (Vertical Augmentation) Width (horizontal augmentation) gained after augmentation of atrophic mandible in millimeters using cone beam computed tomography (measuring tool) measurment tools : with the aid of cone beam computed tomography
1 secondary outcome
Rate of Soft Tissue Dehiscence
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Background: PubMed 22140660Misch CM. Bone augmentation of the atrophic posterior mandible for dental implants using rhBMP-2 and titanium mesh: clinical technique and early results. Int J Periodontics Restorative Dent. 2011 Nov-Dec;31(6):581-9.
- Background: PubMed 22285340Her S, Kang T, Fien MJ. Titanium mesh as an alternative to a membrane for ridge augmentation. J Oral Maxillofac Surg. 2012 Apr;70(4):803-10. doi: 10.1016/j.joms.2011.11.017. Epub 2012 Jan 28.
- Results publication: PubMed 18980518Pieri F, Corinaldesi G, Fini M, Aldini NN, Giardino R, Marchetti C. Alveolar ridge augmentation with titanium mesh and a combination of autogenous bone and anorganic bovine bone: a 2-year prospective study. J Periodontol. 2008 Nov;79(11):2093-103. doi: 10.1902/jop.2008.080061.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Adham Y Zakaria, Master contact
Mohamed F Shehab, PHD study director
Professor of Oral and Maxillofacial Surgery - Cairo University.
Khaled A Salaheddin, PHD study director
Lecturer of Oral and Maxillofacial Surgery - Cairo 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 under local anasthesia,Ridge Augmention of posterior atrophic mandible by using mix of autogenous bone graft and bone substitutes is used under PEEK mesh in people with Mandible Small, 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 4 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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adham Y Zakaria, Master (00201226000564, amira_5queens@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertical amount of bone increased (length in millimeters). horizontal amount f bone increased after augmentation (width in millimeters). (time frame: 6 months). 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 NCT04017117, which also lists 3 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 20 Jul 2022.