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Ridge AugmentationNCT06891313

One Stage Ridge Splitting Using 2 Different Techniques in the Posterior Mandible

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. The control group ridge splitting with simultaneous implants using the conventional technique and study group ridge splitting with simultaneous implants using the piezo surgery. 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 mandibular 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 Posterior Mandible Region (Randomized Clinical Trial)

The selected patients will be informed of the nature of the research work and informed consent will be obtained.

The control group ridge splitting with simultaneous implants using the conventional technique and study group ridge splitting with simultaneous implants using the piezo surgery.

Read more
  • Pre operative procedures 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:

  • In Recipient site, incision of full thickness mucoperiosteal flap inorder to obtain, three-line pyramidal flap, followed by flap reflection.
  • The defective site is reevaluated.
  • Flap advancement using periosteal releasing incision.
  • In the Study group: Piezo surgery bone inserts are used.
  • In the Control group: Bone discs diameter are used.
  • Followed by bone chisels.
  • The point and pilot implant drills are used followed by the sequential use of bone expanders. Based on the preexisting bone, the defect morphology and bone quality. The implant is submerged below the alveolar crest.
  • 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.
  • Double line closure using horizontal mattress sutures followed by interrupted sutures on top 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 ridge splitting with simultaneous implants using the conventional technique and study group ridge splitting with simultaneous implants using the piezo surgery.

  • Pre operative procedures 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 as well as the mandible by the assistant.
  • 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 posterior mandible., Piezo Surgery

What participants receive

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

  • Piezo Surgery.Device

    Using bone cutting inserts.

  • Bone DiscsProcedure or surgery

    Selected bone discs diameters mounted on contra angled hand piece and external irrigation hand piece at gear ratio 1:1.

Study groups in NCT06891313
Study groupRoleWhat they receive
Study Group A: Piezo Surgery.Active comparatorPiezo 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.
Receives: Device: Piezo Surgery.
Control Group B: Bone Discs.Active comparatorBone 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.
Receives: Procedure: Bone Discs

What is being measured

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

  1. Bone Quantity of bone gain.

    Measured using linear measurements from Cone Beam Computed Tomography 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
NCT06891313
Sponsor's protocol ID
000-0001-6142-0568
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

  • Aghaloo 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 18437791
  • Jensen OT, Bell W, Cottam J. Osteoperiosteal flaps and local osteotomies for alveolar reconstruction. Oral Maxillofac Surg Clin North Am. 2010 Aug;22(3):331-46, vi. doi: 10.1016/j.coms.2010.04.003.

    PubMed 20713266
  • Bravi F, Bruschi GB, Ferrini F. A 10-year multicenter retrospective clinical study of 1715 implants placed with the edentulous ridge expansion technique. Int J Periodontics Restorative Dent. 2007 Dec;27(6):557-65.

    PubMed 18092450
  • Tolstunov L, Hamrick JFE, Broumand V, Shilo D, Rachmiel A. Bone Augmentation Techniques for Horizontal and Vertical Alveolar Ridge Deficiency in Oral Implantology. Oral Maxillofac Surg Clin North Am. 2019 May;31(2):163-191. doi: 10.1016/j.coms.2019.01.005.

    PubMed 30947846
  • Tolstunov L. Classification of the alveolar ridge width: implant-driven treatment considerations for the horizontally deficient alveolar ridges. J Oral Implantol. 2014 Jul;40 Spec No:365-70. doi: 10.1563/aaid-joi-D-14-00023. Epub 2014 Feb 27.

    PubMed 24575743
  • Hammerle CH, Jung RE. Bone augmentation by means of barrier membranes. Periodontol 2000. 2003;33:36-53. doi: 10.1046/j.0906-6713.2003.03304.x. No abstract available.

    PubMed 12950840
  • Urban IA, Nagursky H, Lozada JL. Horizontal ridge augmentation with a resorbable membrane and particulated autogenous bone with or without anorganic bovine bone-derived mineral: a prospective case series in 22 patients. Int J Oral Maxillofac Implants. 2011 Mar-Apr;26(2):404-14.

    PubMed 21483894
  • Urban IA, Nagursky H, Lozada JL, Nagy K. Horizontal ridge augmentation with a collagen membrane and a combination of particulated autogenous bone and anorganic bovine bone-derived mineral: a prospective case series in 25 patients. Int J Periodontics Restorative Dent. 2013 May-Jun;33(3):299-307. doi: 10.11607/prd.1407.

    PubMed 23593623
  • Pellegrino G, Lizio G, Corinaldesi G, Marchetti C. Titanium Mesh Technique in Rehabilitation of Totally Edentulous Atrophic Maxillae: A Retrospective Case Series. J Periodontol. 2016 May;87(5):519-28. doi: 10.1902/jop.2016.150432. Epub 2016 Jan 12.

    PubMed 26759078
  • Misch CM. Comparison of intraoral donor sites for onlay grafting prior to implant placement. Int J Oral Maxillofac Implants. 1997 Nov-Dec;12(6):767-76.

    PubMed 9425757
  • Montazem A, Valauri DV, St-Hilaire H, Buchbinder D. The mandibular symphysis as a donor site in maxillofacial bone grafting: a quantitative anatomic study. J Oral Maxillofac Surg. 2000 Dec;58(12):1368-71. doi: 10.1053/joms.2000.18268.

    PubMed 11117684
  • Clavero J, Lundgren S. Ramus or chin grafts for maxillary sinus inlay and local onlay augmentation: comparison of donor site morbidity and complications. Clin Implant Dent Relat Res. 2003;5(3):154-60. doi: 10.1111/j.1708-8208.2003.tb00197.x.

    PubMed 14575631
  • Pourabbas R, Nezafati S. Clinical results of localized alveolar ridge augmentation with bone grafts harvested from symphysis in comparison with ramus. J Dent Res Dent Clin Dent Prospects. 2007 Spring;1(1):7-12. doi: 10.5681/joddd.2007.002. Epub 2007 Jun 10.

    PubMed 23277827

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 Quantity 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 NCT06891313, which also lists 13 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.

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