Clinical Evaluation of Stability of Implants Placed in Partially Edentulous Maxilla With Poor Bone Quality Via New Reverse Drilling Technique Versus Osteotome Technique.

Clinical Evaluation of Stability of Implants Placed in Partially Edentulous Maxilla With Poor Bone Quality Via New Reverse Drilling Technique Versus Osteotome Technique: A Randomized Controlled Clinical Trial

The study will compare between osteotome technique and New Reverse Drilling Technique in the placement of dental implant in posterior maxilla , primary outcome will be Implant stability that will be measured by Periotest device . follow up for 6 month.

secondary outcomes will be crestal bone loss , pain and swelling.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Implant
• Intervention / Treatment: Procedure: osteotome technique; Procedure: New Reverse Drilling technique

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Partially edentulous patients in the maxillary posterior region.
2. Systemically healthy patient.
3. Presence of proper inter-arch space for placement of the implant prosthetic part.
4. Sufficient bone height and width for implant placement (bone height ≥10mm and bone width ≥6mm).
5. Non-smoker.
6. Patients who are ≥ 20 years old.
7. Good oral hygiene.
8. Acceptance of a one year follow-up period.
9. Informed consent is provided by the patient.

Exclusion criteria:

1. Patients with systemic conditions that may interfere with implant stability,
2. Patients with local pathological defects related to the area of interest.
3. Unmotivated, uncooperative patients with poor oral hygiene.
4. Patients with habits that may jeopardize the implant longevity and affect the results of the study such as alcoholism or parafunctional habits.
5. Inadequate inter-arch space for implant prosthetic part

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: osteotome group	Procedure: osteotome technique; a technique for dental implant placement by using the osteotome to condense the bone and create an osteotome rather than cutting the bone
Experimental: New Reverse Drilling technique	Procedure: New Reverse Drilling technique; a new technique of dental implant drilling that promote osseodensification by rotating the drills anti-clockwise rather than clockwise to promote bone condensation rather than bone cutting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
implant stability	the stability of the dental implant when placed in the maxilla of the patient and it will be measured by periotest	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
crestal bone loss	amount of bone loss around the implant . measured in MM with CBVT radiograph	6 monthz

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: September 5, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 5, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: PER6-3-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No