Clinical trial NCT06404944: Using of Implants With a Sloped Platform Edge
Official title: The Use of Implants With a Sloped Platform Edge in Patients With Ridge Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Resorption
Keywords: Alveolar ridge atrophy
Implant design
Bone loss
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Non-inclusion criteria:

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.

Primary outcomes:
measure: determination of the level of the marginal bone
timeFrame: Day 180 compared to the 0th day (initial value)
Secondary outcomes:
measure: Attached mucosa measurement
timeFrame: day 0 (initial value)]
measure: Attached mucosa measurement
timeFrame: day 180 compared to the 0th day (initial value)
measure: Evaluation of soft tissue aesthetics
timeFrame: day 180 compared to the 0th day (initial value)]
measure: Assessment of the quality of life
timeFrame: Day 0 (initial value).]
measure: Assessment of the quality of life
timeFrame: Day 1 compared to the 0th day (initial value
measure: Assessment of the quality of life
timeFrame: Day 3 compared to the 0th day (initial value).
measure: Assessment of the quality of life
timeFrame: Day 5 compared to the 0th day (initial value)
measure: Assessment of the quality of life
timeFrame: Day 7 compared to the 0th day (initial value
measure: Assessment of the quality of life
timeFrame: Day 90 compared to the 0th day (initial value)
measure: Assessment of the quality of life
timeFrame: Day 180 compared to the 0th day (initial value
measure: Assessment of consumption of analgesics
timeFrame: Day 1 compared to the 0th day (initial value)
measure: Assessment of consumption of analgesics
timeFrame: Day 3 compared to the 0th day (initial value)
measure: Assessment of consumption of analgesics
timeFrame: Day 5 compared to the 0th day (initial value)
measure: Assessment of consumption of analgesics
timeFrame: Day 7 compared to the 0th day (initial value)
measure: Assessment of consumption of analgesics
timeFrame: Day 90 compared to the 0th day (initial value)
measure: Assessment of the collateral edema
timeFrame: Day 1 compared to the 0th day (initial value)
measure: Assessment of the collateral edema
timeFrame: Day 3 compared to the 0th day (initial value)
measure: Assessment of the collateral edema
timeFrame: Day 5 compared to the 0th day (initial value)
measure: Assessment of the collateral edema
timeFrame: Day 7 compared to the 0th day (initial value)
measure: Assessment of the severity of pain syndrome
timeFrame: Day 1 compared to the 0th day (initial value)
measure: Assessment of the severity of pain syndrome
timeFrame: Day 3 compared to the 0th day (initial value)
measure: Assessment of the severity of pain syndrome
timeFrame: Day 5 compared to the 0th day (initial value)
measure: Assessment of the severity of pain syndrome
timeFrame: Day 7 compared to the 0th day (initial value)
measure: Assessment of the severity of pain syndrome
timeFrame: Day 90 compared to the 0th day (initial value)
measure: Operating time estimation
timeFrame: Day 1 compared to the 0th day (initial value)
measure: Implant Stability Quotient (ISQ)
timeFrame: Day 1 compared to the 0th day (initial value)
measure: Implant Stability Quotient (ISQ)
timeFrame: Day 180 compared to the 0th day (initial value)
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: I.M. Sechenov First Moscow State Medical University (Sechenov University)
Study officials:
References: