Using of Implants With a Sloped Platform Edge

NCT06404944 | Completed

• 1 other identifier: AI-04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

An interventional prospective randomized clinical trial (RCT) was conducted in parallel groups. The sample size consisted of 30 patients who were randomly assigned to two groups based on the type of surgical intervention. The first group received implants with a sloped edge platform (Dentsply Sirona CIS, ASTRA TECH Implant System, registered in Russia on 21/12/2019, No. РЗН 2015/3214). The second group received implants with bone grafting. The assessment in the postoperative period included evaluating the condition of the soft tissues, bone resorption, number of analgesics, duration of the operation, edema, keratinized mucosa width, implant stability quotient, pain severity, and quality of life.

Conditions

Bone Resorption

Keywords

Alveolar ridge atrophy; Implant design; Bone loss

Outcome Measures

Primary Outcomes (1)

• determination of the level of the marginal bone

  This parameter was determined by analyzing radiovisiography performed on the Vatech EzSensor device (Vatech, South Korea) with an X-ray load of 2μSv 6 months after the operation (after completion of prosthetics). The radiographs were studied using X-ray software on a 27-inch monitor (ASUS) with a screen resolution of 2560 × 1440 pixels. The marginal bone level was assessed using a measuring tool built into the program. The reference point for measurement was the implant shoulder on the medial and distal sides.

  Day 180 compared to the 0th day (initial value)

Secondary Outcomes (27)

• Attached mucosa measurement

  day 0 (initial value)]

• Attached mucosa measurement

  day 180 compared to the 0th day (initial value)

• Evaluation of soft tissue aesthetics

  day 180 compared to the 0th day (initial value)]

• Assessment of the quality of life

  Day 0 (initial value).]

• Assessment of the quality of life

  Day 1 compared to the 0th day (initial value

Study Arms (2)

Slope Implant

EXPERIMENTAL

The patients received implants with a sloped platform edge.

Procedure: implantation

Implant and guided bone regeneration

ACTIVE COMPARATOR

The patients received implants and guided bone regeneration

Procedure: implantation

Interventions

implantation PROCEDURE

1. Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation 2. Placement of the Astra Tech Implant EV Profile (Astra Tech Implant System®; Dentsply Sirona CIS, Sweden) 3. Placement healing abutment 4. Suturing the wound tightly

Slope Implant

Eligibility Criteria

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

You may qualify if:

• Availability of voluntary informed consent to participate in the study.
• The presence of an H1I bone defect according to the Cologne classification.
• Neighboring teeth without hard tissue pathologies and periodontal pathologies.
• Full sanitation of the oral cavity.
• The presence of concomitant pathology in the stage of decompensation;
• Hard smokers (more than 10 cigarettes per day);
• Radio and chemotherapy in history over the past 5 years;
• Pregnancy and breastfeeding;
• Taking medications that affect the healing of soft tissues (nonsteroidal anti-inflammatory drug, steroid drugs).

You may not qualify if:

• Pregnancy following entrance into the study;
• Patients having poor oral hygiene or not wanting to carry out oral hygiene measures;
• Patients who, for one reason or another, could not complete the entire protocol to the end.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, Russia

Location

MeSH Terms

Conditions

Bone Resorption; Bone Diseases, Metabolic

Interventions

Drug Implants

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 8, 2024
• Study Start: January 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: April 1, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)