Using of Implants With a Sloped Platform Edge

NCT ID: NCT06404944

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2024-04-01

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.

Detailed Description

The research aimed to compare the clinical and radiological assessment of soft and hard tissues surrounding implants with a sloped edge platform. Thirty patients with alveolar ridge atrophy were examined at the Department of Surgical Dentistry of the E.V. Borovsky Institute of Dentistry, I.M. Sechenov First Moscow State Medical University. These patients displayed a deficiency in hard tissue width, necessitating augmentation for dental implant placement. Patients were randomly divided into two groups based on treatment methods. 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 underwent treatment with implants of a "standard" design combined with bone grafting. Gender and age characteristics were matched between the groups for comparability.

Patients in the first group were implanted with sloped edge platform implants, while the second group received implants with a different design (Dentsply Sirona CIS, ASTRA TECH Implant System, registered in Russia on 21/12/2019, No. РЗН 2015/3214) incorporating guided bone regeneration. All groups underwent muco-periosteal flap mobilization followed by wound closure without tension using simple interrupted sutures.

In the early postoperative phase, antibacterial and anti-inflammatory therapy was combined with the use of local antiseptics for daily care. Implant uncovering with healing abutment installation occurred 4-6 months post-intervention. The postoperative assessments included evaluating soft tissue condition, bone resorption, analgesic consumption, operation duration, edema, keratinized mucosa width, implant stability quotient, pain severity, and quality of life.

Conditions

Bone Resorption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Slope Implant

The patients received implants with a sloped platform edge.

Group Type: EXPERIMENTAL

implantation

Intervention Type: 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

Implant and guided bone regeneration

The patients received implants and guided bone regeneration

Group Type: ACTIVE_COMPARATOR

implantation

Intervention Type: PROCEDURE

1. Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation

2. Placement of the Astra Tech OsseoSpeed® TX dental implant (Astra Tech Implant System®; Dentsply Sirona CIS, Sweden)

3. Guided bone regeneration with xenogeneic bone material Bio-oss® (Geistlich Pharma AG, Sweden) and collagen membrane Bio-Gide® (Geistlich Pharma AG, Sweden)

4. Suturing the wound tightly

Interventions

implantation

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

Intervention Type: PROCEDURE

implantation

1. Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation

2. Placement of the Astra Tech OsseoSpeed® TX dental implant (Astra Tech Implant System®; Dentsply Sirona CIS, Sweden)

3. Guided bone regeneration with xenogeneic bone material Bio-oss® (Geistlich Pharma AG, Sweden) and collagen membrane Bio-Gide® (Geistlich Pharma AG, Sweden)

4. Suturing the wound tightly

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Availability of voluntary informed consent to participate in the study.

2. The presence of an H1I bone defect according to the Cologne classification.

3. Neighboring teeth without hard tissue pathologies and periodontal pathologies.

4. Full sanitation of the oral cavity.

1. The presence of concomitant pathology in the stage of decompensation;

2. Hard smokers (more than 10 cigarettes per day);

3. Radio and chemotherapy in history over the past 5 years;

4. Pregnancy and breastfeeding;

5. Taking medications that affect the healing of soft tissues (nonsteroidal anti-inflammatory drug, steroid drugs).

Exclusion Criteria

1. Patients with infections either periodontally or periapically, which developed after inclusion in the study;

2. Pregnancy following entrance into the study;

3. Patients having poor oral hygiene or not wanting to carry out oral hygiene measures;

4. Patients who, for one reason or another, could not complete the entire protocol to the end.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Moscow, , Russia

Countries

Russia

Other Identifiers

AI-04

Identifier Type: -

Identifier Source: org_study_id