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AzTrials

Ridge AugmentationNCT06891261

One Stage Ridge Splitting Using 2 Different Techniques in Maxilla

A study testing Piezo Surgery. and Bone Discs. in people with Ridge Augmentation and Bone Augmentation, run by Cairo University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The selected patients will be informed of the nature of the research work and informed consent will be obtained. Patients of both groups will be subjected to CBCT. Intra operative procedures (for both groups) followed by CBCT will be taken for every patient after 4 months. Read more about this study

Who is it for?
Ages 20 to 48 years
Conditions the study is for
Ridge Augmentation, Bone Augmentation
What is being tested?
Piezo Surgery. and Bone Discs.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteEgypt
Study dates
26 Feb 2025to 31 Oct 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 48 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients with maxilla residual alveolar bone height not less than 8 mm.
  • Alveolar bone width from 5mm to 3mm.
  • Both genders.
  • At least single missing tooth.
  • Previous failed implants.
  • Tapered or cylinder cross sectioned alveolar bone defect pattern.

Who cannot join

  • Heavy smokers more than 20 cigarettes per day.
  • Patients with bone disease that may affect normal healing, example; hyperparathyroidism.
  • Patients had radiotherapy and chemotherapy in head and neck.
  • Patients had neoplasms in sites to be grafted.
  • Patients with Metabolic diseases uncontrolled diabetic patients, Glycated hemoglobin (Hb A1c) more than 7 mg\dl.
  • Pregnant females.
Show all 13Show fewer
  • Patients with Para functional habits, apprehensive and non-cooperative.
  • Bone pathology related to the site to be grafted.
  • Psychological problems, stress situation (socially or professionally), emotional instability, and unrealistic patients' expectations.
  • Intraoral soft and hard tissue pathology.
  • Systemic condition that contraindicates implant placement.
  • Under the age of 18 years.
  • Hourglass defects or defects with bone concavities and or undercuts.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site, 1 recruiting
  • Faculty of Dentistry Cairo University

    Cairo, 11553

    Ahmed M. Youssef, Lecturer, +201067941236 ext. +20, ahmed.youssef@dentistry.cu.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Evaluation of Endosseous Implants in One Stage Ridge Splitting Using the Conventional Technique Versus the Use of Piezo Surgery in the Maxilla

  • The selected patients will be informed of the nature of the research work and informed consent will be obtained.
  • Patients of both groups will be subjected to CBCT.
  • Intra operative procedures (for both groups) followed by CBCT will be taken for every patient after 4 months.
  • Infiltration local anesthesia will be given to the patient (Articaine 4% 1:100 000 epinephrine)

Both the study and control group will receive:

Read more
  • In Recipient site, full thickness mucoperiosteal flap pyramidal flap, reflection using mucoperiosteal elevator.
  • The defective site is reevaluated.
  • Flap advancement inorder to allow tension free flap closure.
  • In the Study group: Piezo surgery bone inserts is used to cut crestal osteotomies.
  • In the Control group: Bone discs diameter is used.
  • Followed by, the use of bone chisels.
  • The point and pilot implant drills are used followed by bone expanders. Based on the preexisting bone, the defect morphology and bone quality. The implant is submerged below the alveolar crest to compensate for crestal bone resorption.
  • Following partial immobilization of the buccal bone segment either book or island pattern. The fixture is inserted submerged below the alveolar bone crest.

Followed by bone smoothening and roundation under external saline irrigation at recommended speed of 38000rpm and gear ratio 1:1 calibrated on fesiodespenser.

  • Xenogenic bone particle size of 0.5 mm to 1mm is going to be condensed into the dead space.
  • Recheck adequate flap advancement to allow tension free closure.
  • Double line closure using horizontal mattress followed by interrupted sutures to allow contact area and wound edge eversion.
Read the detailed description
  • The selected patients will be informed of the nature of the research work and informed consent will be obtained then randomized in equal proportions between control group conventional ridge splitting and study ridge splitting using piezo surgery.
  • Patients of both groups will be subjected to CBCT (diagnostic for upper arch), diagnostic wax-up and stent fabrication.
  • Intra operative procedures (for both groups) followed by CBCT will be taken for every patient after 4 months.
  • Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
  • Infiltration local anesthesia will be given to the patient (Articaine 4% 1:100 000 epinephrine)

Both the study and control group will receive:

  • In Recipient site, using 15C blade on Bard Parker handle incision of full thickness mucoperiosteal flap inorder to obtain, three-line pyramidal flap, reflection using mucoperiosteal elevator molt 9.
  • The defective site is reevaluated after its primary evaluation on CBCT using UNC periodontal probe.
  • Flap advancement using periosteal releasing incision inorder to allow later tension free flap closure.
  • In the Study group: Piezo surgery bone inserts is used to cut crestal osteotomy in the center of the alveolar bone ridge bucco-lingual traversing the compact bone into the spongiosa Followed by two semi vertical osteotomies at least 1.5mm away from the adjacent teeth.
  • In the Control group: Bone discs diameter 7mm mounted on contra angled 1:1 is used to cut crestal osteotomy in the center of the alveolar bone ridge bucco-lingual traversing the compact bone into the spongiosa Followed by two semi vertical osteotomies at least 1.5mm away from the adjacent teeth using bone discs diameter 6.5mm mounted on external irrigation straight hand piece.
  • First, the spatula bone chisels are used to make sure of extension of osteotomies into the spongy bone in addition to, adequate free of the cut corners, followed by sequential use of tapered bi-angled bone chisels and hammering with bone mallet 3mm shorter than the length of the proposed implant to gain adequate 1ry stability with concurrent support of the buccal plate of bone.
  • The point and pilot implant drills are used followed by the sequential use of bone expanders diameters 2.6, 3, 3.4, 3.8 to place an implant of diameter 3.7 or 4.1mm. Based on the preexisting bone, the defect morphology and bone quality. The implant is submerged about 2mm to 3mm below the alveolar crest to compensate for crestal bone resorption.
  • Following partial immobilization of the buccal bone segment either book or island pattern. The fixture is inserted submerged below the alveolar bone crest by 2mm to 3mm. Followed by bone smoothening and roundation using large round diamond stone mounted on straight hand piece with external saline irrigation at recommended speed of 38000rpm and gear ratio 1:1 calibrated on fesiodespenser. To avoid soft tissue irritation.
  • Xenogenic bone particle size of 0.5 mm to 1mm is going to be condensed into the dead space. To act as a scaffold for the formation of autogenous bone.
  • Recheck adequate flap advancement by visualizing passive flap approximation, to allow tension free closure.
  • Double line closure using horizontal mattress placed 5mm away from flap margins followed by interrupted sutures on top to allow contact area which is preferred to point contact and wound edge eversion.
Being tested
Piezo Surgery., Bone Discs.
Keywords
ridge augmentation, One stage ridge splitting in maxilla., Piezo Surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Piezo Surgery.Device

    Piezotome woodpecker®: Surgic touch.

  • Bone Discs.Procedure or surgery

    bone discs mounted on staight hand piece and contra angled 1:1 gear ratio.

Study groups in NCT06891261
Study groupRoleWhat they receive
Study Group A: Piezo Surgery.Active comparatorStraight and angled bone inserts were utilized.
Receives: Device: Piezo Surgery.
Control Group B: Conventional Technique.Active comparatorusing bone discs of 7mm diameter mounted on contra angled 1:1 and 6.5mm diameter bone discs mounted on 1:1 external irrigation straight hand piece.
Receives: Procedure: Bone Discs.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bone Quality of bone gain.

    Measured using linear measurements from CBCT in millimeters.

    Measured: At 4 months from ridge augmentation.

Secondary outcomes (1)
  1. Soft Tissue Dehiscence.

    Exposure of the augmented site. Written Binary Numerical.

    Measured: Baseline 1st Week.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2025
  2. Study start26 Feb 2025
  3. Primary completion30 Jul 2025 (estimated)
  4. Study completion31 Oct 2025 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06891261
Sponsor's protocol ID
00-0001-6142-0568
Status last verified
Jul 2025
First submitted
16 Feb 2025
Last updated
16 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Spin-Neto R, Landazuri Del Barrio RA, Pereira LA, Marcantonio RA, Marcantonio E, Marcantonio E Jr. Clinical similarities and histological diversity comparing fresh frozen onlay bone blocks allografts and autografts in human maxillary reconstruction. Clin Implant Dent Relat Res. 2013 Aug;15(4):490-7. doi: 10.1111/j.1708-8208.2011.00382.x. Epub 2011 Aug 11.

    PubMed 21834864
  • Acocella A, Bertolai R, Ellis E 3rd, Nissan J, Sacco R. Maxillary alveolar ridge reconstruction with monocortical fresh-frozen bone blocks: a clinical, histological and histomorphometric study. J Craniomaxillofac Surg. 2012 Sep;40(6):525-33. doi: 10.1016/j.jcms.2011.09.004. Epub 2011 Nov 9.

    PubMed 22075326
  • Dasmah A, Thor A, Ekestubbe A, Sennerby L, Rasmusson L. Particulate vs. block bone grafts: three-dimensional changes in graft volume after reconstruction of the atrophic maxilla, a 2-year radiographic follow-up. J Craniomaxillofac Surg. 2012 Dec;40(8):654-9. doi: 10.1016/j.jcms.2011.10.032. Epub 2011 Dec 3.

    PubMed 22137760
  • AlGhamdi AS. Post-surgical complications of symphyseal block graft with and without soft tissue grafting. Saudi Med J. 2013 Jun;34(6):609-15.

    PubMed 23756926
  • Monje A, Monje F, Chan HL, Suarez F, Villanueva-Alcojol L, Garcia-Nogales A, Wang HL. Comparison of microstructures between block grafts from the mandibular ramus and calvarium for horizontal bone augmentation of the maxilla: a case series study. Int J Periodontics Restorative Dent. 2013 Nov-Dec;33(6):e153-61. doi: 10.11607/prd.1664.

    PubMed 24116370
  • Aloy-Prosper A, Penarrocha-Oltra D, Penarrocha-Diago M, Penarrocha-Diago M. The outcome of intraoral onlay block bone grafts on alveolar ridge augmentations: a systematic review. Med Oral Patol Oral Cir Bucal. 2015 Mar 1;20(2):e251-8. doi: 10.4317/medoral.20194.

    PubMed 25662543
  • Reininger D, Cobo-Vazquez C, Monteserin-Matesanz M, Lopez-Quiles J. Complications in the use of the mandibular body, ramus and symphysis as donor sites in bone graft surgery. A systematic review. Med Oral Patol Oral Cir Bucal. 2016 Mar 1;21(2):e241-9. doi: 10.4317/medoral.20938.

    PubMed 26827063
  • Khoury F: Augmentation of severe bony defects with intraoral bone grafts: biological approach and long-term results J Oral Maxillo Fac Surg 2017Volume 46, Supplement 1, Pages 26-27.

  • Claudino M, Julio C L, Luis E M, Bernardo M, Fernando G, tomographic evaluation of atrophic maxilla rehabilitated with autogenous and xenogeneic block grafts. Journal of Research in Dentistry 2017, 4(4):112-117.

Questions about this trial

What is this clinical trial studying?

A study testing Piezo Surgery. and Bone Discs. in people with Ridge Augmentation and Bone Augmentation, 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 6 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 16 Jul 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mohannad A. Ismail, MSc. (01222968444 ext. +20, mohannadahmed@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone Quality of bone gain. (time frame: At 4 months from ridge augmentation.). 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 NCT06891261, which also lists 9 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 16 Jul 2025; AzTrials last refreshed its copy on 27 Oct 2026.

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