Implant Stability of Laser vs SLA Surface Treated Implants Placed in Fresh Extraction Sockets

NCT04092920 | Unknown DMC

• 1 other identifier: PRO 6-3-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Commercially available implant surfaces are moderately roughened surfaces and they are obtained by acid-etching following alumina or titanium oxide grit-blasting. Although the micro-rough implants can be successful in compromised clinical scenarios, the bioinert nature of titanium surfaces cannot stimulate a more rapid bone regeneration and mechanical fixation of dental implants. Laser surface treatment is used to produce an implant surface modification on the nano-scale with controlled and reproducible patterns in addition to exhibiting a sterilizing effect and achieving efficient oxidation .

Conditions

Implant Site Reaction

Outcome Measures

Primary Outcomes (1)

• rate of change in implant stability at baseline,2,4,8,12 weeks

  measuring implant stability with Resonance Frequency Analysis device using Implant stability quotient (ISQ) units that measure the stiffness and deflection of the implant-bone complex.

  3 months

Study Arms (1)

laser and SLA implants

EXPERIMENTAL

extraction of badly broken maxillary and mandibular teeth with immediate implant placement using laser surface treated and SLA surface treated dental implants

Device: laser and SLA

Interventions

laser and SLA DEVICE

ligible patients will be randomized to 2 groups control group will receive SLA surface treated implant to replace badly broken tooth immediately after extraction and a study group will receive laser surface treated implant to replace badly broken tooth immediately after extraction. atraumatic extraction will be performed and socket will be examined for presence of bone dehesince or fenestration if no, implant will be placed immediately and a implant primary stability will be measured using an ISQ unit and recorded as base Line reading . gingival former will be attached to the implant and removed at 2 ,4,8,12 week intervals to record ISQ readings.

laser and SLA implants

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with badly broken teeth indicated for extraction. • Presence of adequate bone beyond the root apex to guarantee implant primary stability \& implant placement within the alveoli confines.

You may not qualify if:

• Presence of acute infections in the implant site.
• Presence of fenestrations or dehiscence of the residual bony walls after extraction.
• Heavy smokers more than 20 cigarettes per day.
• Patients with systemic disease that may affect normal healing.
• Psychiatric problems.
• Disorders to implant are related to history of radiation therapy to the head and neck neoplasia.
• Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Central Study Contacts

ahmed mohamed mohamed abd el maksoud, bds

CONTACT

01061597677; drabdelmaksoud33@gmail.com

amr hosny el khadem, associate professor

CONTACT

01001162401; amr.elkhadem@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 17, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: September 24, 2019

Record last verified: 2019-09

Locations

EG (1)