Actively Recruiting

Phase Not Applicable
Age: 20Years - 48Years
All Genders
ID06891261

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

Led by Cairo University · Updated on 2025-07-16

20

Participants Needed

1

Research Sites

13 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating two techniques for ridge splitting in the upper jaw (maxilla) to support dental implants. The study compares a conventional method using bone discs with an approach using piezo surgery, aiming to assess bone gain quality and healing outcomes in patients with specific bone conditions and missing teeth. This is an interventional trial sponsored by Cairo University involving adults aged 20 to 48 years. Both groups undergo similar surgical steps including local anesthesia, flap creation, bone exposure, and implant placement below the bone crest. The study group receives piezo surgery bone inserts to cut the crestal osteotomy, while the control group uses bone discs mounted on handpieces for the same purpose. Additional procedures include bone chiseling, implant drilling, bone smoothing, and placement of xenogenic bone particles into the surgical site. Closure is performed with a double line suture technique to ensure tension-free healing. Participants will have cone beam computed tomography (CBCT) scans before and four months after surgery to evaluate bone gain. Other assessments include evaluation of soft tissue healing one week after surgery. The study involves randomized allocation to one of the two surgical techniques with single blinding. Monitoring includes clinical evaluations of bone and soft tissue, with the primary outcome measured four months after ridge augmentation, and a total participation duration covering preoperative assessment through postoperative follow-up.

CONDITIONS

Brief Title

One Stage Ridge Splitting Using 2 Different Techniques in Maxilla

Who Can Participate

Age: 20Years - 48Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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

You will not qualify if you...

  • Heavy smokers more than 20 cigarettes per day
  • Patients with bone diseases affecting healing, such as hyperparathyroidism
  • Patients who had radiotherapy or chemotherapy in head and neck
  • Patients with neoplasms in graft sites
  • Patients with uncontrolled metabolic diseases, including diabetes with HbA1c over 7 mg/dl
  • Pregnant females
  • Patients with parafunctional habits or who are apprehensive and non-cooperative
  • Bone pathology related to graft site
  • Psychological problems, social or professional stress, emotional instability, or unrealistic expectations
  • Intraoral soft and hard tissue pathology
  • Systemic conditions contraindicating implant placement
  • Under 18 years of age
  • Hourglass defects or defects with bone concavities or undercuts in the graft site

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Single day for surgery

Participants undergo one-stage ridge splitting surgery using either the conventional technique with bone discs or piezo surgery. Local anesthesia is administered, and implants are placed followed by bone grafting and wound closure.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - 4 months

Participants receive follow-up care including CBCT imaging and assessment of bone quality and soft tissue healing after surgery.

1 follow-up visit at 4 months post-surgery

Trial Site Locations

Total: 1 location

1

Faculty of Dentistry Cairo University

Cairo, Egypt, 11553

Actively Recruiting

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Research Team

M

Mohannad A. Ismail, MSc.

A

Ahmed M Youssef, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Clinical similarities and histological diversity comparing fresh frozen onlay bone blocks allografts and autografts in human maxillary reconstruction.

Rubens Spin-Neto, Ricardo Andrés Landazuri Del Barrio, Luis Antonio Violin Dias Pereira...

https://pubmed.ncbi.nlm.nih.gov/21834864

Maxillary alveolar ridge reconstruction with monocortical fresh-frozen bone blocks: a clinical, histological and histomorphometric study.

Alessandro Acocella, Roberto Bertolai, Edward Ellis...

https://pubmed.ncbi.nlm.nih.gov/22075326

Particulate vs. block bone grafts: three-dimensional changes in graft volume after reconstruction of the atrophic maxilla, a 2-year radiographic follow-up.

Amir Dasmah, Andreas Thor, Annika Ekestubbe...

https://pubmed.ncbi.nlm.nih.gov/22137760

Comparison of microstructures between block grafts from the mandibular ramus and calvarium for horizontal bone augmentation of the maxilla: a case series study.

Alberto Monje, Florencio Monje, Hsun-Liang Chan...

https://pubmed.ncbi.nlm.nih.gov/24116370

The outcome of intraoral onlay block bone grafts on alveolar ridge augmentations: a systematic review.

Amparo Aloy-Prósper, David Peñarrocha-Oltra, Maria Peñarrocha-Diago...

https://pubmed.ncbi.nlm.nih.gov/25662543

Complications in the use of the mandibular body, ramus and symphysis as donor sites in bone graft surgery. A systematic review.

David Reininger, Carlos Cobo-Vázquez, Marta Monteserín-Matesanz...

https://pubmed.ncbi.nlm.nih.gov/26827063