Ridge Expansion by Osseodensification Simultaneously With Implant Placement in Narrow Alveolar Ridges

NCT03592381 | Unknown

• 1 other identifier: 14422015497758
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Narrow alveolar ridges with a thickness equal or less than 5 mm requires bone augmentation procedures before or at the time of implant placement. (Anitua, Begoña, and Orive 2013) Several surgical techniques have been utilized for the reconstruction of deficient alveolar ridges such as block onlay graft augmentation, guided bone regeneration, distraction osteogenesis , ridge splitting and/or ridge expansion(McAllister and Haghighat 2007). A new bone drilling technique named Osseodensification facilitates horizontal ridge expansion. Studies are needed to validate the effectiveness of osseodensification as a lateral ridge augmentation procedure that aims at increasing the thickness of atrophic ridges, thus maintaining ridge integrity and allowing for implant placement with enhanced stability. The null hypothesis Proposes no difference in the bone width gain following the osseodensification drilling system compared to the ridge splitting technique with simultaneously placed implants in narrow alveolar ridges.

Conditions

Alveolar Ridge Augmentation

Outcome Measures

Primary Outcomes (1)

• Change in bone width

  Using Cone beam computed tomography bone width gain will be reported in millimeters.

  Baseline and six month post surgically

Secondary Outcomes (5)

• Change in Implant stability Quotients

  at the time of surgery and 6 month post surgical

• soft tissue healing at 1 week using the Healing index by Landry,Turnbull and Howley (1988) to describe the extent of clinical healing after periodontal surgery.

  1 week post surgically.

• soft tissue healing at 2 weeks using the Healing index by Landry,Turnbull and Howley 1988 to describe the extent of clinical healing after periodontal surgery.

  2 weeks post surgically

• Changes in Crestal Bone level

  at the time of enrollment and 6 month post surgically

• Pain scale using the numerical Visual analog scale.

  1 week post surgically

Study Arms (2)

Ridge expansion by osseodensification

EXPERIMENTAL

Ridge expansion and osteotomy drilling by osseodensification in conjunction with simultaneous implant placement in narrow ridges.

Procedure: Ridge Expansion by ossedensification

Ridge expansion by ridge splitting

ACTIVE COMPARATOR

Ridge expansion by ridge splitting using the piezotome in conjunction with simultaneous implant placement in narrow ridges.

Procedure: ridge expansion by ridge splitting

Interventions

Ridge Expansion by ossedensification PROCEDURE

Osseodensification is a new concept facilitated by Densah® Burs which are a multi- fluted osteotome like drilling instrumentsThe idea behind the technique is using a non-subtractive drilling mode that preserves bone and increases its density along the osteotomy walls instead of cutting it away (Huwais and Meyer 2015)

Ridge expansion by osseodensification

ridge expansion by ridge splitting PROCEDURE

using the piezotome,Piezoelectric ridge splitting allows exact, clean, and smooth even curved cutting of the bone tissue, with proper visibility.

Ridge expansion by ridge splitting

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with at least one missing tooth in need of replacement.
• Patients having a Bucco-lingual/palatal width of the edentulous alveolar ridge less than 6 mm with a minimum of 3mm residual bone width.
• Patients having at least 11 mm residual bone height at the proposed edentulous area.
• The recipient bed of the implant should be free from any pathological conditions.
• No history of diagnosed bone disease or medication known to affect bone metabolism.
• Patients who are cooperative, motivated, and hygiene conscious.

You may not qualify if:

• Patients incapable to undergoing minor oral surgical procedures.
• Patients with insufficient vertical inter-arch space, upon centric occlusion, to accommodate the available restorative components.
• Patients who have any systemic condition that may contraindicate implant therapy.
• Patients with modifying habits affecting osteointegration for example, smoking and alcoholism.
• Patients with parafunctional habits that can overload the implant, such as bruxism and clenching.
• Patients with impractical expectations about the esthetic outcome of implant therapy.
• Patients in the growth stage with mixed dentition.
• Patients with a history of drug abuse.
• Patients with a history of psychiatric disorder.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

The Faculty of Dentistry -Cairo University

Cairo, Egypt

Location

Study Officials

• Radwa A ElMaghrabi, BSC

  Cairo University

  PRINCIPAL INVESTIGATOR

• Amr zahran, PHD

  Cairo University

  STUDY DIRECTOR

• Ahmed Al barbary, PHD

  Cairo University

  STUDY CHAIR

Central Study Contacts

Radwa A ELMaghrabi, BCS

CONTACT

00201018626244; Radwaelmaghrabi@gmail.com

Amr Zahran, PHD

CONTACT

00201018626244; dramrzahran@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double Blinded, Parallel group, Randomized controlled trial.

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 19, 2018
• Study Start: August 30, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: July 31, 2018

Record last verified: 2018-07

Locations

EG (1)