Jaw DeformityNCT04192851
Evaluation of "Tent-Pole" Grafting Technique for Reconstruction of Mandibular Ridge Vertical Defects
A study testing Tent Pole Technique in people with Jaw Deformity, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate clinically and radio-graphically the efficiency of "Tent- Pole "grafting technique for reconstruction of anterior or posterior mandibular ridge defects using synthetic bone graft and Platelet Rich Fibrin (PRF) membrane. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Jaw Deformity
- What is being tested?
- Tent Pole Technique
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2019to 30 Nov 2019
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with missing lower tooth or teeth and have a related large vertical bony defect .
- Patients with about 7mm residual bone hight and requiring about 5 mm increase in the vertical height of the mandibular alveolar ridge for future prosthetic rehabilitation.
- Patients with an acceptable oral hygiene and willing to improve it
Who cannot join
- Presence of infection or local lesions.
- Parafunctional habits.
- Current chemotherapy or radiotherapy.
- Heavy smokers.
- Alcohol or drug abuse.
- Medically compromised patients with diseases that affect passively the clinical procedure or result.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of "Tent-Pole" Grafting Technique for Reconstruction of Mandibular Ridge Vertical Defects (Clinical and Radiographic Study)
The aim of this study is to evaluate clinically and radio-graphically the efficiency of "Tent- Pole "grafting technique for reconstruction of anterior or posterior mandibular ridge defects using synthetic bone graft and Platelet Rich Fibrin (PRF) membrane.
Read the detailed description
Various techniques have been described for the reconstruction of large vertical defects before implant placement . In this study we assessed the efficacy of tenting the periosteum and soft tissue matrix with titanium screws maintaining a space for the graft material in order to augment large vertical defects of mandibular ridge (anterior or posterior region) using data from 12 patients . After 6 months we assessed the increase in bone height and density.
- Conditions
- Jaw Deformity
- Being tested
- Tent Pole Technique
- Medical subject headings
- Jaw Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tent Pole TechniqueProcedure or surgery
- All patients were operated under local or general anaesthesia according to the case and patient tolerability.
- The oral cavity was prepared by 0.12% chlorhexidine mouthrinses solution* for thirty seconds.
- Full thickness incision down to the bone with blade no.15.
- A periosteal elevator was used to perform mucoperiosteal flap.
- Gentle elevation of the flap
- Fixation of the screws over the alveolar ridge with about 5 mm of the screw threads will be exposed
- Bone graft was mixed with the patient blood and placed to cover the screws completely.
- PRF membrane was be placed over the grafted sites.
- Repositioning of the flap and suturing with 3/0 black silk suture material
| Study group | Role | What they receive |
|---|---|---|
| Tent Pole Grafting Technique | Experimental | * Bone graft [NanoBone® granulate 0,6 mm (24% Silica / 76% Hydroxylapatite)] is mixed with the patient blood and placed to cover the screws completely, the defect is overcorrected with particulate material in anticipation of future graft resorption.
* PRF membrane is prepared by:
Ten milliliters of whole venous blood will be collected in sterile glass test tubes without anticoagulant. Then the test tubes will be placed in a table centrifuge machine at 3000 revolutions per minute (rpm) for 10 minutes.After separation of PRF, the membrane is prepared compression device. Receives: Procedure: Tent Pole Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment using Visual Analogue Scale
Pain was assessed through on a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
Measured: 2 weeks
Postoperative edema
Edema was evaluated by its ability to pit.The examiner fingers pressed into dependent area of the patient skin for 5 seconds. The finger sinks into the tissue and leave an impression when they are removed. The pitting was graded on a scale of +1 to +4 as follows:
- 1 (trace) slight indentation rapid return to normal.
- 2 (mild) the indentation returns to normal in a few seconds.
- 3 (moderate) 6 mm indentation rebounds in 10-20 seconds.
- 4 (severe) 8 mm indentation rebounds in more than 30 seconds.
Measured: 2 weeks
Radiographic Evaluation for Bone Density using Cone Beam CT
A Cone Beam Computerized Tomography was obtained to assess the gained bone height \&density.
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 posted10 Dec 2019
- Study start20 Jan 2019
- Primary completion15 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Jaw DeformityStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm trial of 12 patients with mandibular large vertical defects treated using synthetic bone graft around titanium screws to tent out the soft tissue matrix.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Asmaa M Abd ElFattah, BDS, Principal investigator, Faculty of Dentistry, Alexandria University, EgyptAbd El Aziz F Khalil, PhD, Study chair, Faculty of Dentistry, Alexandria University, EgyptLydia N.F Melek, PhD, Study director, Faculty of Dentistry, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192851
- Sponsor's protocol ID
- Tent-pole graft
- Status last verified
- Jul 2020
- First submitted
- 7 Dec 2019
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jensen SS, Terheyden H. Bone augmentation procedures in localized defects in the alveolar ridge: clinical results with different bone grafts and bone-substitute materials. Int J Oral Maxillofac Implants. 2009;24 Suppl:218-36.
PubMed 19885447Chiapasco M, Casentini P, Zaniboni M. Bone augmentation procedures in implant dentistry. Int J Oral Maxillofac Implants. 2009;24 Suppl:237-59.
PubMed 19885448Aghaloo TL, Moy PK. Which hard tissue augmentation techniques are the most successful in furnishing bony support for implant placement? Int J Oral Maxillofac Implants. 2007;22 Suppl:49-70.
PubMed 18437791Le B, Burstein J, Sedghizadeh PP. Cortical tenting grafting technique in the severely atrophic alveolar ridge for implant site preparation. Implant Dent. 2008 Mar;17(1):40-50. doi: 10.1097/ID.0b013e318166d503.
PubMed 18332757
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of "Tent-Pole" Grafting Technique for Reconstruction of Mandibular Ridge Vertical Defects (Clinical and Radiographic Study)
- ClinicalTrials.gov ID
- NCT04192851
- Acronym / sponsor ID
- Tent-pole graft
- Conditions
- Jaw Deformity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 10 Dec 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.
The aim of this study is to evaluate clinically and radio-graphically the efficiency of "Tent- Pole "grafting technique for reconstruction of anterior or posterior mandibular ridge defects using synthetic bone graft and Platelet Rich Fibrin (PRF) membrane.
Detailed description
Various techniques have been described for the reconstruction of large vertical defects before implant placement . In this study we assessed the efficacy of tenting the periosteum and soft tissue matrix with titanium screws maintaining a space for the graft material in order to augment large vertical defects of mandibular ridge (anterior or posterior region) using data from 12 patients . After 6 months we assessed the increase in bone height and density.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm trial of 12 patients with mandibular large vertical defects treated using synthetic bone graft around titanium screws to tent out the soft tissue matrix.
| Arm | Type | Receives |
|---|---|---|
| Tent Pole Grafting Technique | Experimental | Procedure: Tent Pole Technique* Bone graft [NanoBone® granulate 0,6 mm (24% Silica / 76% Hydroxylapatite)] is mixed with the patient blood and placed to cover the screws completely, the defect is overcorrected with particulate material in anticipation of future graft resorption. * PRF membrane is prepared by: Ten milliliters of whole venous blood will be collected in sterile glass test tubes without anticoagulant. Then the test tubes will be placed in a table centrifuge machine at 3000 revolutions per minute (rpm) for 10 minutes.After separation of PRF, the membrane is prepared compression device. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with missing lower tooth or teeth and have a related large vertical bony defect .
- Patients with about 7mm residual bone hight and requiring about 5 mm increase in the vertical height of the mandibular alveolar ridge for future prosthetic rehabilitation.
- Patients with an acceptable oral hygiene and willing to improve it
Key exclusion criteria (6 listed)
- Presence of infection or local lesions.
- Parafunctional habits.
- Current chemotherapy or radiotherapy.
- Heavy smokers.
- Alcohol or drug abuse.
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 |
|---|---|---|
| Tent Pole Technique* All patients were operated under local or general anaesthesia according to the case and patient tolerability. * The oral cavity was prepared by 0.12% chlorhexidine mouthrinses solution* for thirty seconds. * Full thickness incision down to the bone with blade no.15. * A periosteal elevator was used to perform mucoperiosteal flap. * Gentle elevation of the flap * Fixation of the screws over the alveolar ridge with about 5 mm of the screw threads will be exposed * Bone graft was mixed with the patient blood and placed to cover the screws completely. * PRF membrane was be placed over the grafted sites. * Repositioning of the flap and suturing with 3/0 black silk suture material | Procedure or surgery | Tent Pole Grafting Technique |
Primary outcome
Pain assessment using Visual Analogue Scale
Time frame: 2 weeks
Pain was assessed through on a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
Postoperative edema
Time frame: 2 weeks
Edema was evaluated by its ability to pit.The examiner fingers pressed into dependent area of the patient skin for 5 seconds. The finger sinks into the tissue and leave an impression when they are removed. The pitting was graded on a scale of +1 to +4 as follows: * 1 (trace) slight indentation rapid return to normal. * 2 (mild) the indentation returns to normal in a few seconds. * 3 (moderate) 6 mm indentation rebounds in 10-20 seconds. * 4 (severe) 8 mm indentation rebounds in more than 30 seconds.
Radiographic Evaluation for Bone Density using Cone Beam CT
Time frame: 6 months
A Cone Beam Computerized Tomography was obtained to assess the gained bone height \&density.
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 28 Jul 2020.
- Background: PubMed 19885447Jensen SS, Terheyden H. Bone augmentation procedures in localized defects in the alveolar ridge: clinical results with different bone grafts and bone-substitute materials. Int J Oral Maxillofac Implants. 2009;24 Suppl:218-36.
- Background: PubMed 19885448Chiapasco M, Casentini P, Zaniboni M. Bone augmentation procedures in implant dentistry. Int J Oral Maxillofac Implants. 2009;24 Suppl:237-59.
- Background: PubMed 18437791Aghaloo TL, Moy PK. Which hard tissue augmentation techniques are the most successful in furnishing bony support for implant placement? Int J Oral Maxillofac Implants. 2007;22 Suppl:49-70.
- Background: PubMed 18332757Le B, Burstein J, Sedghizadeh PP. Cortical tenting grafting technique in the severely atrophic alveolar ridge for implant site preparation. Implant Dent. 2008 Mar;17(1):40-50. doi: 10.1097/ID.0b013e318166d503.
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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.
Asmaa M Abd ElFattah, BDS principal investigator
Faculty of Dentistry, Alexandria University, Egypt
Abd El Aziz F Khalil, PhD study chair
Faculty of Dentistry, Alexandria University, Egypt
Lydia N.F Melek, PhD study director
Faculty of Dentistry, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tent Pole Technique in people with Jaw Deformity, run by Nourhan M.Aly 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 3 inclusion and 6 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 28 Jul 2020. 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?
Pain assessment using Visual Analogue Scale (time frame: 2 weeks). The study lists 3 primary outcomes in all. 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 NCT04192851, which also lists 4 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 28 Jul 2020.