Bone ResorptionNCT06404944
Using of Implants With a Sloped Platform Edge
A study testing implantation in people with Bone Resorption, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Bone Resorption
- What is being tested?
- implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2021to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Non-inclusion criteria:
- The presence of concomitant pathology in the stage of decompensation;
Show all 10Show fewer
- 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).
Who cannot join
- Patients with infections either periodontally or periapically, which developed after inclusion in the study;
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow
About this study
Official title: The Use of Implants With a Sloped Platform Edge in Patients With Ridge Atrophy
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.
Read the 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
- Being tested
- implantation
- Keywords
- Alveolar ridge atrophy, Implant design, Bone loss
- Medical subject headings
- Bone Resorption, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implantationProcedure or surgery
- Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation
- Placement of the Astra Tech Implant EV Profile (Astra Tech Implant System®; Dentsply Sirona CIS, Sweden)
- Placement healing abutment
- Suturing the wound tightly
implantationProcedure or surgery
- Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation
- Placement of the Astra Tech OsseoSpeed® TX dental implant (Astra Tech Implant System®; Dentsply Sirona CIS, Sweden)
- Guided bone regeneration with xenogeneic bone material Bio-oss® (Geistlich Pharma AG, Sweden) and collagen membrane Bio-Gide® (Geistlich Pharma AG, Sweden)
- Suturing the wound tightly
| Study group | Role | What they receive |
|---|---|---|
| Slope Implant | Experimental | The patients received implants with a sloped platform edge. Receives: Procedure: implantation |
| Implant and guided bone regeneration | Active comparator | The patients received implants and guided bone regeneration Receives: Procedure: implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 180 compared to the 0th day (initial value)
Secondary outcomes (27)
Attached mucosa measurement
Evaluation of the width of the keratinized gum will be carried out using a periodontological probe. The width is measured between the mucosal-gingival junction between the vestibular and oral sides.
Measured: day 0 (initial value)]
Attached mucosa measurement
Evaluation of the width of the keratinized gum will be carried out using a periodontological probe. The width is measured between the mucosal-gingival junction between the vestibular and oral sides.
Measured: day 180 compared to the 0th day (initial value)
Evaluation of soft tissue aesthetics
Evaluation of soft tissue aesthetics will be carried out according to clinical examination data after the installation of the final orthopedic structure using standard PES (Pink esthetic score). points from 0 to 2, where "2" means a result close to natural.
Measured: day 180 compared to the 0th day (initial value)]
Assessment of the quality of life
The patient's quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. points from 0 to 4, where "4" means the worst result
Measured: Day 0 (initial value).]
Assessment of the quality of life
The patient's quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. points from 0 to 4, where "4" means the worst result
Measured: Day 1 compared to the 0th day (initial value
Assessment of the quality of life
The patient's quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. points from 0 to 4, where "4" means the worst result
Measured: Day 3 compared to the 0th day (initial value).
Assessment of the quality of life
The patient's quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. points from 0 to 4, where "4" means the worst result
Measured: Day 5 compared to the 0th day (initial value)
Assessment of the quality of life
The patient's quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. points from 0 to 4, where "4" means the worst result
Measured: Day 7 compared to the 0th day (initial value
Assessment of the quality of life
The patient's quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. points from 0 to 4, where "4" means the worst result
Measured: Day 90 compared to the 0th day (initial value)
Assessment of the quality of life
The patient's quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. points from 0 to 4, where "4" means the worst result
Measured: Day 180 compared to the 0th day (initial value
Assessment of consumption of analgesics
Patients' analgesic consumption was assessed by estimating the number of packs of Nimesulide (100 mg) taken
Measured: Day 1 compared to the 0th day (initial value)
Assessment of consumption of analgesics
Patients' analgesic consumption was assessed by estimating the number of packs of Nimesulide (100 mg) taken
Measured: Day 3 compared to the 0th day (initial value)
Assessment of consumption of analgesics
Patients' analgesic consumption was assessed by estimating the number of packs of Nimesulide (100 mg) taken
Measured: Day 5 compared to the 0th day (initial value)
Assessment of consumption of analgesics
Patients' analgesic consumption was assessed by estimating the number of packs of Nimesulide (100 mg) taken
Measured: Day 7 compared to the 0th day (initial value)
Assessment of consumption of analgesics
Patients' analgesic consumption was assessed by estimating the number of packs of Nimesulide (100 mg) taken
Measured: Day 90 compared to the 0th day (initial value)
Assessment of the collateral edema
Edema will be clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues)
Measured: Day 1 compared to the 0th day (initial value)
Assessment of the collateral edema
Edema will be clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues)
Measured: Day 3 compared to the 0th day (initial value)
Assessment of the collateral edema
Edema will be clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues)
Measured: Day 5 compared to the 0th day (initial value)
Assessment of the collateral edema
Edema will be clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues)
Measured: Day 7 compared to the 0th day (initial value)
Assessment of the severity of pain syndrome
Visual Analogue Scale (VAS). Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
Measured: Day 1 compared to the 0th day (initial value)
Assessment of the severity of pain syndrome
Visual Analogue Scale (VAS). Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
Measured: Day 3 compared to the 0th day (initial value)
Assessment of the severity of pain syndrome
Visual Analogue Scale (VAS). Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where: 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
Measured: Day 5 compared to the 0th day (initial value)
Assessment of the severity of pain syndrome
Visual Analogue Scale (VAS). Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where: 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain
Measured: Day 7 compared to the 0th day (initial value)
Assessment of the severity of pain syndrome
Visual Analogue Scale (VAS). Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where: 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain
Measured: Day 90 compared to the 0th day (initial value)
Operating time estimation
The operative time was measured using chronometry from the time of anesthetic administration to the last suture
Measured: Day 1 compared to the 0th day (initial value)
Implant Stability Quotient (ISQ)
The Implant Stability Quotient (ISQ) was measured using Pinguin device (Integration Diagnostics Sweden AB)
Measured: Day 1 compared to the 0th day (initial value)
Implant Stability Quotient (ISQ)
The Implant Stability Quotient(ISQ) was measured using Pinguin device (Integration Diagnostics Sweden AB)
Measured: Day 180 compared to the 0th day (initial value)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Jan 2021
- Primary completion1 Jan 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone ResorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404944
- Sponsor's protocol ID
- AI-04
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing is impossible because of the recommendation of the local ethics committee, the provision of data is possible upon receipt of an official request addressed to the chief researcher
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Implants With a Sloped Platform Edge in Patients With Ridge Atrophy
- ClinicalTrials.gov ID
- NCT06404944
- Acronym / sponsor ID
- AI-04
- Conditions
- Bone Resorption
- Keywords
- Alveolar ridge atrophy, Implant design, Bone loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slope Implant | Experimental | Procedure: implantationThe patients received implants with a sloped platform edge. |
| Implant and guided bone regeneration | Active comparator | Procedure: implantationThe patients received implants and guided bone regeneration |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (4 listed)
- Patients with infections either periodontally or periapically, which developed after inclusion in the study;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implantation1. 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 | Procedure or surgery | Slope Implant |
| implantation1. 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 | Procedure or surgery | Implant and guided bone regeneration |
Primary outcome
determination of the level of the marginal bone
Time frame: Day 180 compared to the 0th day (initial value)
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.
27 secondary outcomes
Attached mucosa measurement
Time frame: day 0 (initial value)]
Attached mucosa measurement
Time frame: day 180 compared to the 0th day (initial value)
Evaluation of soft tissue aesthetics
Time frame: day 180 compared to the 0th day (initial value)]
Assessment of the quality of life
Time frame: Day 0 (initial value).]
Assessment of the quality of life
Time frame: Day 1 compared to the 0th day (initial value
Assessment of the quality of life
Time frame: Day 3 compared to the 0th day (initial value).
Assessment of the quality of life
Time frame: Day 5 compared to the 0th day (initial value)
Assessment of the quality of life
Time frame: Day 7 compared to the 0th day (initial value
Assessment of the quality of life
Time frame: Day 90 compared to the 0th day (initial value)
Assessment of the quality of life
Time frame: Day 180 compared to the 0th day (initial value
Assessment of consumption of analgesics
Time frame: Day 1 compared to the 0th day (initial value)
Assessment of consumption of analgesics
Time frame: Day 3 compared to the 0th day (initial value)
Assessment of consumption of analgesics
Time frame: Day 5 compared to the 0th day (initial value)
Assessment of consumption of analgesics
Time frame: Day 7 compared to the 0th day (initial value)
Assessment of consumption of analgesics
Time frame: Day 90 compared to the 0th day (initial value)
Assessment of the collateral edema
Time frame: Day 1 compared to the 0th day (initial value)
Assessment of the collateral edema
Time frame: Day 3 compared to the 0th day (initial value)
Assessment of the collateral edema
Time frame: Day 5 compared to the 0th day (initial value)
Assessment of the collateral edema
Time frame: Day 7 compared to the 0th day (initial value)
Assessment of the severity of pain syndrome
Time frame: Day 1 compared to the 0th day (initial value)
Assessment of the severity of pain syndrome
Time frame: Day 3 compared to the 0th day (initial value)
Assessment of the severity of pain syndrome
Time frame: Day 5 compared to the 0th day (initial value)
Assessment of the severity of pain syndrome
Time frame: Day 7 compared to the 0th day (initial value)
Assessment of the severity of pain syndrome
Time frame: Day 90 compared to the 0th day (initial value)
Operating time estimation
Time frame: Day 1 compared to the 0th day (initial value)
Implant Stability Quotient (ISQ)
Time frame: Day 1 compared to the 0th day (initial value)
Implant Stability Quotient (ISQ)
Time frame: Day 180 compared to the 0th day (initial value)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No. IPD sharing is impossible because of the recommendation of the local ethics committee, the provision of data is possible upon receipt of an official request addressed to the chief researcher
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implantation in people with Bone Resorption, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determination of the level of the marginal bone (time frame: Day 180 compared to the 0th day (initial value)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.