Alveolar Ridge Augmentation, Dental ImplantsRCTNCT06987149
A Randomized Controlled Trial Evaluating Dental Implant Placement in the Anterior Esthetic Zone Using Two Guided Bone Regeneration Techniques: Prefabricated CAD/CAM Zirconia Membrane vs. Contour Augmentation.
A study testing CAD/CAM Zirconia Membrane and Contour Augmentation in people with Alveolar Ridge Augmentation, Dental Implants and Alveolar Ridge Deficiency in the Anterior Esthetic Zone, run by Mohammed Mashhout Eisa Anas at 1 site in Egypt.
Trial summary
This clinical trial aims to compare two guided bone regeneration (GBR) techniques in patients with horizontal ridge deficiency in the anterior esthetic region. Specifically, it evaluates the use of a prefabricated CAD/CAM zirconia membrane versus conventional contour augmentation performed simultaneously with dental… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Alveolar Ridge Augmentation, Dental Implants, Alveolar Ridge Deficiency in the Anterior Esthetic Zone
- What is being tested?
- CAD/CAM Zirconia Membrane and Contour Augmentation
- Type of treatment
- Medical device, 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 Nov 2024to Jul 2025
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Patients of both genders within the age range of 20-50 years.
- Patients with good general health and adequate oral hygiene practices.
- Stable periodontal condition and favorable soft tissue profile.
- Alveolar ridge that has a Class I defect according to Seibert's classification of ridge defects.
Who cannot join
- Patients with medical conditions or systemic diseases precluding periodontal surgery or hampering wound healing (e.g., uncontrolled diabetes mellitus or metabolic bone disorders).
- Patients subjected to irradiation in the head and neck area.
- Patients with a history of taking any medications in the previous 6 months that may interfere with periodontal tissue health or healing.
- Patients have poor oral hygiene and motivation.
- Patients with active periodontitis or acute infection in the area intended for implant placement.
- Females who are pregnant or trying to conceive, and nursing mothers.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dentistry- Tanta university
Tanta, Gharbia Governorate, 3111
About this study
Official title: Prefabricated CAD/CAM Zirconia Membrane Versus Contour Augmentation Simultaneously With Dental Implant Placement in the Anterior Esthetic Area.
This clinical trial aims to compare two guided bone regeneration (GBR) techniques in patients with horizontal ridge deficiency in the anterior esthetic region. Specifically, it evaluates the use of a prefabricated CAD/CAM zirconia membrane versus conventional contour augmentation performed simultaneously with dental implant placement. The study includes male and female patients aged 20 to 50 years who are in good general health, maintain adequate oral hygiene, and present with a Class I ridge defect as per Seibert's classification.
The primary objective is to determine whether the customized zirconia membrane provides equivalent clinical and radiographic outcomes in terms of bone gain and soft tissue healing compared to the contour augmentation technique. Participants will also report their postoperative discomfort and overall satisfaction using a 100-point visual analog scale (VAS), recorded at multiple time points: 1, 6, and 12 hours, as well as 1, 3, 7, and 15 days postoperatively.
- Conditions
- Alveolar Ridge Augmentation, Dental Implants, Alveolar Ridge Deficiency in the Anterior Esthetic Zone
- Being tested
- CAD/CAM Zirconia Membrane, Contour Augmentation
- Keywords
- Alveolar ridge augmentation, Dental implant, Guided bone regeneration, Countour augmentation, Prefabricated CAD/CAM zirconia membrane, Alveolar ridge deficiency, Anterior Esthetic Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD/CAM Zirconia MembraneDevice
A prefabricated, non-resorbable zirconia membrane fabricated using CAD/CAM technology for guided bone regeneration in horizontal ridge deficiencies during simultaneous dental implant placement.
Contour AugmentationProcedure or surgery
Traditional guided bone regeneration using particulate bone graft and a resorbable collagen membrane, placed concurrently with the dental implant to augment horizontal ridge deficiencies.
| Study group | Role | What they receive |
|---|---|---|
| CAD/CAM Zirconia Membrane Group | Experimental | Participants in this group will undergo guided bone regeneration using a customized, prefabricated CAD/CAM zirconia membrane designed based on the individual's ridge defect morphology. This membrane will be used in combination with particulate bone graft material and placed simultaneously with the dental implant in the anterior maxilla. Receives: Device: CAD/CAM Zirconia Membrane |
| Contour Augmentation Group | Active comparator | Participants in this group will undergo conventional guided bone regeneration using particulate bone graft material covered with a resorbable collagen membrane. The grafting procedure will be performed simultaneously with dental implant placement in the anterior maxilla. Receives: Procedure: Contour Augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar bone gain in millimetres (mm) in the edentulous alveolar ridge
Assessment of the horizontal and vertical bone gain in millimetres (mm) in the edentulous alveolar ridge from baseline (implant placement and grafting) to six months after surgery.
Measured: Six months
Secondary outcomes (3)
Periodontal Soft Tissue Healing (Modified Wound Healing Index - MWHI)
Evaluation of periodontal soft tissue healing around the surgical site using the Modified Wound Healing Index (MWHI) developed by Huang et al. This index categorizes wound healing based on clinical parameters including mucosal edema, erythema, graft exposure, and presence of suppuration. Scores range from 1 to 3:
Score 1 - Uneventful Healing: No or minimal mucosal edema or erythema, with no suppuration or graft exposure.
Score 2 - Normal Healing: Slight to moderate mucosal edema, erythema, and/or graft exposure, but without suppuration.
Score 3 - Poor Healing: Significant mucosal edema, erythema, graft exposure, and presence of suppuration.
Measured: Baseline (day of surgery), and postoperatively at 4, 8, 12, and 24 weeks
Patient-Reported Postoperative Discomfort and Satisfaction
Assessment of postoperative discomfort and overall patient satisfaction using a 100-point Visual Analog Scale (VAS). Participants will self-report their pain levels and satisfaction at multiple postoperative time points: 1, 6, and 12 hours, as well as 1, 3, 7, and 15 days after surgery.
Measured: 1 hour, 6 hours, 12 hours, and 1, 3, 7, 15 days postoperatively
Membrane-Related Operative Time
Measurement of the time (in minutes) required to place the guided bone regeneration membrane during the surgical procedure. This will assess the efficiency and ease of use of the prefabricated CAD/CAM zirconia membrane compared to conventional contour augmentation.
Measured: Recorded during the implant placement and bone regeneration surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Nov 2024
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alveolar Ridge Augmentation, Dental ImplantsStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammed Mashhout Eisa Anas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammed Mashhout Eisa Anas, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987149
- Sponsor's protocol ID
- OMPDR 5-23 2
- Acronym
- RCT
- Status last verified
- May 2024
- First submitted
- 14 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Anas MM, Gabr AM, El-Makaky Y, Helal MH. Prefabricated CAD/CAM zirconia membrane versus contour augmentation with early implant placement in the anterior maxilla: a randomized controlled clinical trial. Int J Implant Dent. 2026 Aug 24;12(1):43. doi: 10.1186/s40729-026-00711-4.
PubMed 42638027
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prefabricated CAD/CAM Zirconia Membrane Versus Contour Augmentation Simultaneously With Dental Implant Placement in the Anterior Esthetic Area.
- ClinicalTrials.gov ID
- NCT06987149
- Acronym / sponsor ID
- RCT / OMPDR 5-23 2
- Conditions
- Alveolar Ridge Augmentation, Dental Implants, Alveolar Ridge Deficiency in the Anterior Esthetic Zone
- Keywords
- Alveolar ridge augmentation, Dental implant, Guided bone regeneration, Countour augmentation, Prefabricated CAD/CAM zirconia membrane, Alveolar ridge deficiency, Anterior Esthetic Zone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mohammed Mashhout Eisa AnasUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 23 May 2025 (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.
This clinical trial aims to compare two guided bone regeneration (GBR) techniques in patients with horizontal ridge deficiency in the anterior esthetic region. Specifically, it evaluates the use of a prefabricated CAD/CAM zirconia membrane versus conventional contour augmentation performed simultaneously with dental implant placement. The study includes male and female patients aged 20 to 50 years who are in good general health, maintain adequate oral hygiene, and present with a Class I ridge defect as per Seibert's classification.
The primary objective is to determine whether the customized zirconia membrane provides equivalent clinical and radiographic outcomes in terms of bone gain and soft tissue healing compared to the contour augmentation technique. Participants will also report their postoperative discomfort and overall satisfaction using a 100-point visual analog scale (VAS), recorded at multiple time points: 1, 6, and 12 hours, as well as 1, 3, 7, and 15 days postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM Zirconia Membrane Group | Experimental | Device: CAD/CAM Zirconia MembraneParticipants in this group will undergo guided bone regeneration using a customized, prefabricated CAD/CAM zirconia membrane designed based on the individual's ridge defect morphology. This membrane will be used in combination with particulate bone graft material and placed simultaneously with the dental implant in the anterior maxilla. |
| Contour Augmentation Group | Active comparator | Procedure: Contour AugmentationParticipants in this group will undergo conventional guided bone regeneration using particulate bone graft material covered with a resorbable collagen membrane. The grafting procedure will be performed simultaneously with dental implant placement in the anterior maxilla. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients of both genders within the age range of 20-50 years.
- Patients with good general health and adequate oral hygiene practices.
- Stable periodontal condition and favorable soft tissue profile.
- Alveolar ridge that has a Class I defect according to Seibert's classification of ridge defects.
Key exclusion criteria (6 listed)
- Patients with medical conditions or systemic diseases precluding periodontal surgery or hampering wound healing (e.g., uncontrolled diabetes mellitus or metabolic bone disorders).
- Patients subjected to irradiation in the head and neck area.
- Patients with a history of taking any medications in the previous 6 months that may interfere with periodontal tissue health or healing.
- Patients have poor oral hygiene and motivation.
- Patients with active periodontitis or acute infection in the area intended for implant placement.
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 |
|---|---|---|
| CAD/CAM Zirconia MembraneA prefabricated, non-resorbable zirconia membrane fabricated using CAD/CAM technology for guided bone regeneration in horizontal ridge deficiencies during simultaneous dental implant placement. | Device | CAD/CAM Zirconia Membrane Group |
| Contour AugmentationTraditional guided bone regeneration using particulate bone graft and a resorbable collagen membrane, placed concurrently with the dental implant to augment horizontal ridge deficiencies. | Procedure or surgery | Contour Augmentation Group |
Primary outcome
Alveolar bone gain in millimetres (mm) in the edentulous alveolar ridge
Time frame: Six months
Assessment of the horizontal and vertical bone gain in millimetres (mm) in the edentulous alveolar ridge from baseline (implant placement and grafting) to six months after surgery.
3 secondary outcomes
Periodontal Soft Tissue Healing (Modified Wound Healing Index - MWHI)
Time frame: Baseline (day of surgery), and postoperatively at 4, 8, 12, and 24 weeks
Patient-Reported Postoperative Discomfort and Satisfaction
Time frame: 1 hour, 6 hours, 12 hours, and 1, 3, 7, 15 days postoperatively
Membrane-Related Operative Time
Time frame: Recorded during the implant placement and bone regeneration surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Derived from this study: PubMed 42638027Anas MM, Gabr AM, El-Makaky Y, Helal MH. Prefabricated CAD/CAM zirconia membrane versus contour augmentation with early implant placement in the anterior maxilla: a randomized controlled clinical trial. Int J Implant Dent. 2026 Aug 24;12(1):43. doi: 10.1186/s40729-026-00711-4.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAD/CAM Zirconia Membrane and Contour Augmentation in people with Alveolar Ridge Augmentation, Dental Implants and Alveolar Ridge Deficiency in the Anterior Esthetic Zone, run by Mohammed Mashhout Eisa Anas 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 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: status not confirmed, as of the sponsor's last update on 23 May 2025. 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?
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?
Alveolar bone gain in millimetres (mm) in the edentulous alveolar ridge (time frame: Six 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 NCT06987149, which also lists 1 linked publication.
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 23 May 2025.