Alveolar Bone LossNCT06209905
Khoury Technique Versus Titanium Reinforced PTFE Membrane in 3D Alveolar Bone Augmentation
A study testing Alveolar ridge augmentation in people with Alveolar Bone Loss, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
In patients with missed lower posterior teeth and resorbed lower jaw, the study aimed at restoring the jaw's height and width to accommodate placing dental implants. The study was designed as a clinical trial with two arms; control group and study group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Alveolar ridge augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to 1 Jul 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age above 18 years old.
- Good oral hygiene.
- Missing mandibular posterior teeth.
- No history of bruxism or para-functional habits.
- Residual alveolar ridge height cannot accommodate dental implant placement.
- Patients prepared to comply with the follow-up and maintenance program.
- Agreement and signing the informed consent.
Who cannot join
- Systemic diseases that may contraindicate the surgery or affect soft tissue or bone healing.
- Heavy smoking (more than 20 cigarettes/day).
- Intraosseous pathological lesion at the intended grafting site.
- Gingival inflammation at the intended implant site.
- Periodontal diseases affecting teeth adjacent to the edentulous space.
- Inadequate inter-arch space after the indented vertical augmentation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Khoury Technique Versus Titanium Reinforced PTFE Membrane in 3D Alveolar Bone Augmentation in Atrophic Posterior Mandible
In patients with missed lower posterior teeth and resorbed lower jaw, the study aimed at restoring the jaw's height and width to accommodate placing dental implants. The study was designed as a clinical trial with two arms; control group and study group. In the control group, titanium-reinforced polytetrafluoroethylene (Ti PTFE) membrane was used to secure the grafted bone mixture in the recipient site. While in the study group, bone-plate technique (Khoury technique) for bone restoration was used to secure the grafted bone mixture as well. The donor bone was the lower jaw (for bone particles and bone-plate harvesting) and bovine bone particles mixed together to form the graft mixture. Patients were monitored for six months and assessed by X-rays. The outcome variables were volume and height of gained bone in cubic millimeters and millimeters, respectively.
Read the detailed description
This study targeted bone augmentation in atrophic posterior mandible. Two groups were assigned. The first group included titanium-reinforced polytetrafluoroethylene (Ti PTFE) membrane as a rigid modality to achieve guided-bone regeneration (GBR): A mixture of autogenous bone (scrapped from the mandibular external oblique ridge) and bovine xenograft was administered on the atrophic recipient area after decortication by low-speed reducing drills, and covered with the mentioned membrane. The second group utilized rigid bone-plates (a bone block was harvested from the mandibular external oblique ridge, then splitted into two plates; one fixated buccally and the other fixated occlusally by bone screws), and the same bone mixture was prepared and introduced as in the first group. All procedures were operated under local anesthesia in a minor oral surgical setting.
Follow-up time intervals were the first postoperative day, and the sixth postoperative month. Two outcome variables were assessed; gained bone volume and gained bone height.
- Conditions
- Alveolar Bone Loss
- Being tested
- Alveolar ridge augmentation
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar ridge augmentationProcedure or surgery
Alveolar ridge augmentation in the three dimensions with either intervention; Ti-PTFE + bone mixture, or Khoury (Bone-plate) technique + bone mixture.
| Study group | Role | What they receive |
|---|---|---|
| Ti-PTFE | Sham comparator | A mixture of autogenous bone (scrapped from the mandibular external oblique ridge) and bovine xenograft was administered on the atrophic recipient area after decortication by low-speed reducing drills, and covered with the Ti-PTFE membrane. Receives: Procedure: Alveolar ridge augmentation |
| Khoury technique | Active comparator | A bone block was harvested from the mandibular external oblique ridge, then splitted into two plates; one fixated buccally and the other fixated occlusally by bone screws), and a mixture of autogenous bone (scrapped from the mandibular external oblique ridge) and bovine xenograft was administered on the atrophic recipient area after decortication by low-speed reducing drills. Receives: Procedure: Alveolar ridge augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone volume in cubic millimeters
Volume of the gained bone was assessed by cone-beam computed tomography (CBCT)
Measured: First postoperative day
Bone volume in cubic millimeters
Volume of the gained bone was assessed by cone-beam computed tomography (CBCT)
Measured: Sixth postoperative month
Secondary outcomes (2)
Vertical bone height in millimeters
Height of the gained bone was assessed by cone-beam computed tomography (CBCT)
Measured: First postoperative day
Vertical bone height in millimeters
Height of the gained bone was assessed by cone-beam computed tomography (CBCT)
Measured: Sixth postoperative month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Nov 2021
- Primary completion1 Nov 2022
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Sponsor
- Investigators
- Mohamed H Elkenawy, PhD, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209905
- Sponsor's protocol ID
- A06080921
- Status last verified
- Jan 2024
- First submitted
- 6 Jan 2024
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- 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 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Khoury Technique Versus Titanium Reinforced PTFE Membrane in 3D Alveolar Bone Augmentation in Atrophic Posterior Mandible
- ClinicalTrials.gov ID
- NCT06209905
- Acronym / sponsor ID
- A06080921
- Conditions
- Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 18 Jan 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.
In patients with missed lower posterior teeth and resorbed lower jaw, the study aimed at restoring the jaw's height and width to accommodate placing dental implants. The study was designed as a clinical trial with two arms; control group and study group. In the control group, titanium-reinforced polytetrafluoroethylene (Ti PTFE) membrane was used to secure the grafted bone mixture in the recipient site. While in the study group, bone-plate technique (Khoury technique) for bone restoration was used to secure the grafted bone mixture as well. The donor bone was the lower jaw (for bone particles and bone-plate harvesting) and bovine bone particles mixed together to form the graft mixture. Patients were monitored for six months and assessed by X-rays. The outcome variables were volume and height of gained bone in cubic millimeters and millimeters, respectively.
Detailed description
This study targeted bone augmentation in atrophic posterior mandible. Two groups were assigned. The first group included titanium-reinforced polytetrafluoroethylene (Ti PTFE) membrane as a rigid modality to achieve guided-bone regeneration (GBR): A mixture of autogenous bone (scrapped from the mandibular external oblique ridge) and bovine xenograft was administered on the atrophic recipient area after decortication by low-speed reducing drills, and covered with the mentioned membrane. The second group utilized rigid bone-plates (a bone block was harvested from the mandibular external oblique ridge, then splitted into two plates; one fixated buccally and the other fixated occlusally by bone screws), and the same bone mixture was prepared and introduced as in the first group. All procedures were operated under local anesthesia in a minor oral surgical setting.
Follow-up time intervals were the first postoperative day, and the sixth postoperative month. Two outcome variables were assessed; gained bone volume and gained bone height.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ti-PTFE | Sham comparator | Procedure: Alveolar ridge augmentationA mixture of autogenous bone (scrapped from the mandibular external oblique ridge) and bovine xenograft was administered on the atrophic recipient area after decortication by low-speed reducing drills, and covered with the Ti-PTFE membrane. |
| Khoury technique | Active comparator | Procedure: Alveolar ridge augmentationA bone block was harvested from the mandibular external oblique ridge, then splitted into two plates; one fixated buccally and the other fixated occlusally by bone screws), and a mixture of autogenous bone (scrapped from the mandibular external oblique ridge) and bovine xenograft was administered on the atrophic recipient area after decortication by low-speed reducing drills. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age above 18 years old.
- Good oral hygiene.
- Missing mandibular posterior teeth.
- No history of bruxism or para-functional habits.
- Residual alveolar ridge height cannot accommodate dental implant placement.
Key exclusion criteria (6 listed)
- Systemic diseases that may contraindicate the surgery or affect soft tissue or bone healing.
- Heavy smoking (more than 20 cigarettes/day).
- Intraosseous pathological lesion at the intended grafting site.
- Gingival inflammation at the intended implant site.
- Periodontal diseases affecting teeth adjacent to the edentulous space.
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 |
|---|---|---|
| Alveolar ridge augmentationAlveolar ridge augmentation in the three dimensions with either intervention; Ti-PTFE + bone mixture, or Khoury (Bone-plate) technique + bone mixture. | Procedure or surgery | Khoury technique, Ti-PTFE |
Primary outcome
Bone volume in cubic millimeters
Time frame: First postoperative day
Volume of the gained bone was assessed by cone-beam computed tomography (CBCT)
Bone volume in cubic millimeters
Time frame: Sixth postoperative month
Volume of the gained bone was assessed by cone-beam computed tomography (CBCT)
2 secondary outcomes
Vertical bone height in millimeters
Time frame: First postoperative day
Vertical bone height in millimeters
Time frame: Sixth postoperative month
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 18 Jan 2024.
- Individual participant dataSharing planned: No
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Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
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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.
Mohamed H Elkenawy, PhD study director
Mansoura 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 Alveolar ridge augmentation in people with Alveolar Bone Loss, run by Delta University for Science and Technology 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 7 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 18 Jan 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. Some participants in this study may receive a placebo. 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?
Bone volume in cubic millimeters (time frame: First postoperative day). The study lists 2 primary outcomes in all. 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 18 Jan 2024.