Alveolar Bone Lossi-RESNCT03229005
Soft Tissue Width and Abutment Height Influence Peri-implant Bone Resorption
A study testing implant insertion, operculectomy and prosthetic rehabilitation in people with Alveolar Bone Loss, run by International Piezosurgery Academy at 1 site in Italy.
Trial summary
The purpose of this clinical and radiographic study will be to determine what influence on marginal bone loss has the thickness of soft tissues and the height of the prosthetic abutment and eventually determine which of the two factors is the most important.This research was designed as a multicentre cohort study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- implant insertion, operculectomy and prosthetic rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2017to 15 Jun 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- history of head or neck radiation therapy;
- uncontrolled diabetes (HBA1c >7.5%);
- active infections;
- immunocompromised patients (HIV infection or chemotherapy within the past 5 years);
- present or past treatment with intravenous bisphosphonates;
- patient pregnancy or lactating at any time during the study;
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- poor oral hygiene and motivation;
- untreated periodontal disease;
- psychological or psychiatric problems;
- alcohol or drugs abuse;
- participating in other studies, if the present protocol could not be properly followed;
- lack of implant primary stability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Soft Tissue Width and Abutment Height on Peri-implant Bone Resorption: a Clinical and Radiographic Multicenter Study
The purpose of this clinical and radiographic study will be to determine what influence on marginal bone loss has the thickness of soft tissues and the height of the prosthetic abutment and eventually determine which of the two factors is the most important.This research was designed as a multicentre cohort study. Two clinical centers will treat patients through the placement of a single dental implant. The implants will be prosthetically loaded about 4 months after placement and periapical radiographs will be acquired at each time-point.
Read the detailed description
The purpose of this clinical and radiographic study will be to determine what influence on marginal bone loss has the thickness of soft tissues and the height of the prosthetic abutment and eventually determine which of the two factors is the most important.This research was designed as a multicentre cohort observational study. Two clinical centers will treat patients through the placement of a single dental implant. The implants will be prosthetically loaded about 4 months after placement and periapical radiographs will be acquired at each time-point.
All patients will receive antibiotic prophylaxis with 2 g of amoxicillin one hour before surgery. With the help of a dissector, a full thickness vestibular flap will be carefully arranged and the vertical thickness of soft tissues will be measured with a probe marked every 1.0 mm. If the vertical thickness of the soft tissue is 2 mm or less, the tissue will be considered thin. If the thickness of the mucosa is greater than 2 mm, it will be considered thick. After the measurement, the lingual flap will be elevated at full thickness, and the site for site placement will be prepared. The implant bed will be at least 1.5 mm from the adjacent tooth or teeth, and must be surrounded by at least 1 mm bone in both buccal and lingual directions. A 3,75 mm diameter and internal hexagonal connection implant will be placed at the level of the bone crest according to the manufacturer's recommendations. Operators will be free to choose the most suitable system length (8, 10, 11.5 mm). All implants will be submerged according to a traditional two-stage protocol. After insertion, the flaps will be sutured without tension with interrupted sutures. Patients of both groups will be instructed to disinfect the site by rinsing twice daily for one week for 1 minute with 0.12% chlorhexidine. After 4 months of healing, the treated area will be reopened for connecting the healing abutments with a crestal incision that will retain the keratinized tissue; The same soft tissue measurements will be repeated as confirmation of what was done during the first surgical implant insertion phase. The implants will be considered osteointegrated successfully if they are clinically intact unless they show obvious radiotransparency and patients will not report any pain. After this step, it will be possible to divide the patients into 2 groups according to the thickness of the soft tissue: a group with thick tissue (more than 2.0 mm); Slim tissue group (less than 2.0 mm). The prosthetic framework will be bonded directly to prefabricated titanium abutment (1 or 3 mm). This will result in the formation of 4 different subgroups: a group with thick tissue and high prosthetic abutment; A group with thick tissue and low prosthetic stump; a group with thin tissue and high prosthetic abutment; a group with thin tissue and low prosthetic abutment.
All the implants will be rehabilitated by the dentist with screwed restorations. After prosthetic treatment, patients will receive oral hygiene instructions and will be monitored through calls to ensure periodontal health throughout the study period.
- Conditions
- Alveolar Bone Loss
- Being tested
- implant insertion, operculectomy, prosthetic rehabilitation
- Keywords
- soft tissue; implant; abutment;
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant insertionProcedure or surgery
during surgery soft tissues will be measured
operculectomyProcedure or surgery
during second surgery soft tissues will be measured again
prosthetic rehabilitationProcedure or surgery
after three months implants will be loaded with screw retained crown
| Study group | Role | What they receive |
|---|---|---|
| A1 thick-high | Active comparator | group with thick tissue and high prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation Receives: Procedure: implant insertion; Procedure: operculectomy; Procedure: prosthetic rehabilitation |
| A2 thick-low | Experimental | group with thick tissue and low prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation Receives: Procedure: implant insertion; Procedure: operculectomy; Procedure: prosthetic rehabilitation |
| B1 thin-high | Active comparator | group with thin tissue and high prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation Receives: Procedure: implant insertion; Procedure: operculectomy; Procedure: prosthetic rehabilitation |
| B2 thin-low | Experimental | group with thin tissue and low prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation Receives: Procedure: implant insertion; Procedure: operculectomy; Procedure: prosthetic rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
peri-implant bone resorption
intraoral radiographs will be acquired and bone crest level will be compared with baseline
Measured: after 12 months
implant survival
clinical and radiographical examination
Measured: after 12 months
Secondary outcomes (5)
peri-implant bone resorption
intraoral radiographs will be acquired
Measured: immediately after surgery (baseline)
peri-implant bone resorption
intraoral radiographs will be acquired
Measured: four months after surgery (at prosthesis delivery)
peri-implant bone resorption
intraoral radiographs will be acquired
Measured: six months after prosthetic loading
peri-implant bone resorption
intraoral radiographs will be acquired
Measured: 24 months after prosthetic loading
complications and/or adverse events
clinical and radiographical examination
Measured: any time of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start15 May 2017
- Primary completion15 Oct 2018
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone LossStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Piezosurgery Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mr. Claudio Stacchi, DDS, MSc, International Piezosurgery Academy
- Investigators
- Claudio Stacchi, Dr., Principal investigator, Piezosurgery Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229005
- Sponsor's protocol ID
- i-RES
- Acronym
- i-RES
- Status last verified
- Aug 2019
- First submitted
- 22 Jul 2017
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Galindo-Moreno P, Leon-Cano A, Monje A, Ortega-Oller I, O'Valle F, Catena A. Abutment height influences the effect of platform switching on peri-implant marginal bone loss. Clin Oral Implants Res. 2016 Feb;27(2):167-73. doi: 10.1111/clr.12554. Epub 2015 Feb 11.
PubMed 25678247Linkevicius T, Apse P, Grybauskas S, Puisys A. Influence of thin mucosal tissues on crestal bone stability around implants with platform switching: a 1-year pilot study. J Oral Maxillofac Surg. 2010 Sep;68(9):2272-7. doi: 10.1016/j.joms.2009.08.018.
PubMed 20605308
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Soft Tissue Width and Abutment Height on Peri-implant Bone Resorption: a Clinical and Radiographic Multicenter Study
- ClinicalTrials.gov ID
- NCT03229005
- Acronym / sponsor ID
- i-RES / i-RES
- Conditions
- Alveolar Bone Loss
- Keywords
- soft tissue; implant; abutment;
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- International Piezosurgery AcademyUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 25 Jul 2017 (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.
The purpose of this clinical and radiographic study will be to determine what influence on marginal bone loss has the thickness of soft tissues and the height of the prosthetic abutment and eventually determine which of the two factors is the most important.This research was designed as a multicentre cohort study. Two clinical centers will treat patients through the placement of a single dental implant. The implants will be prosthetically loaded about 4 months after placement and periapical radiographs will be acquired at each time-point.
Detailed description
The purpose of this clinical and radiographic study will be to determine what influence on marginal bone loss has the thickness of soft tissues and the height of the prosthetic abutment and eventually determine which of the two factors is the most important.This research was designed as a multicentre cohort observational study. Two clinical centers will treat patients through the placement of a single dental implant. The implants will be prosthetically loaded about 4 months after placement and periapical radiographs will be acquired at each time-point.
All patients will receive antibiotic prophylaxis with 2 g of amoxicillin one hour before surgery. With the help of a dissector, a full thickness vestibular flap will be carefully arranged and the vertical thickness of soft tissues will be measured with a probe marked every 1.0 mm. If the vertical thickness of the soft tissue is 2 mm or less, the tissue will be considered thin. If the thickness of the mucosa is greater than 2 mm, it will be considered thick. After the measurement, the lingual flap will be elevated at full thickness, and the site for site placement will be prepared. The implant bed will be at least 1.5 mm from the adjacent tooth or teeth, and must be surrounded by at least 1 mm bone in both buccal and lingual directions. A 3,75 mm diameter and internal hexagonal connection implant will be placed at the level of the bone crest according to the manufacturer's recommendations. Operators will be free to choose the most suitable system length (8, 10, 11.5 mm). All implants will be submerged according to a traditional two-stage protocol. After insertion, the flaps will be sutured without tension with interrupted sutures. Patients of both groups will be instructed to disinfect the site by rinsing twice daily for one week for 1 minute with 0.12% chlorhexidine. After 4 months of healing, the treated area will be reopened for connecting the healing abutments with a crestal incision that will retain the keratinized tissue; The same soft tissue measurements will be repeated as confirmation of what was done during the first surgical implant insertion phase. The implants will be considered osteointegrated successfully if they are clinically intact unless they show obvious radiotransparency and patients will not report any pain. After this step, it will be possible to divide the patients into 2 groups according to the thickness of the soft tissue: a group with thick tissue (more than 2.0 mm); Slim tissue group (less than 2.0 mm). The prosthetic framework will be bonded directly to prefabricated titanium abutment (1 or 3 mm). This will result in the formation of 4 different subgroups: a group with thick tissue and high prosthetic abutment; A group with thick tissue and low prosthetic stump; a group with thin tissue and high prosthetic abutment; a group with thin tissue and low prosthetic abutment.
All the implants will be rehabilitated by the dentist with screwed restorations. After prosthetic treatment, patients will receive oral hygiene instructions and will be monitored through calls to ensure periodontal health throughout the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1 thick-high | Active comparator | Procedure: implant insertion, Procedure: operculectomy, Procedure: prosthetic rehabilitationgroup with thick tissue and high prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation |
| A2 thick-low | Experimental | Procedure: implant insertion, Procedure: operculectomy, Procedure: prosthetic rehabilitationgroup with thick tissue and low prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation |
| B1 thin-high | Active comparator | Procedure: implant insertion, Procedure: operculectomy, Procedure: prosthetic rehabilitationgroup with thin tissue and high prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation |
| B2 thin-low | Experimental | Procedure: implant insertion, Procedure: operculectomy, Procedure: prosthetic rehabilitationgroup with thin tissue and low prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- history of head or neck radiation therapy;
- uncontrolled diabetes (HBA1c >7.5%);
- active infections;
- immunocompromised patients (HIV infection or chemotherapy within the past 5 years);
- present or past treatment with intravenous bisphosphonates;
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 |
|---|---|---|
| implant insertionduring surgery soft tissues will be measured | Procedure or surgery | A1 thick-high, A2 thick-low, B1 thin-high, B2 thin-low |
| operculectomyduring second surgery soft tissues will be measured again | Procedure or surgery | A1 thick-high, A2 thick-low, B1 thin-high, B2 thin-low |
| prosthetic rehabilitationafter three months implants will be loaded with screw retained crown | Procedure or surgery | A1 thick-high, A2 thick-low, B1 thin-high, B2 thin-low |
Primary outcome
peri-implant bone resorption
Time frame: after 12 months
intraoral radiographs will be acquired and bone crest level will be compared with baseline
implant survival
Time frame: after 12 months
clinical and radiographical examination
5 secondary outcomes
peri-implant bone resorption
Time frame: immediately after surgery (baseline)
peri-implant bone resorption
Time frame: four months after surgery (at prosthesis delivery)
peri-implant bone resorption
Time frame: six months after prosthetic loading
peri-implant bone resorption
Time frame: 24 months after prosthetic loading
complications and/or adverse events
Time frame: any time of the study
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 28 Aug 2019.
- Background: PubMed 25678247Galindo-Moreno P, Leon-Cano A, Monje A, Ortega-Oller I, O'Valle F, Catena A. Abutment height influences the effect of platform switching on peri-implant marginal bone loss. Clin Oral Implants Res. 2016 Feb;27(2):167-73. doi: 10.1111/clr.12554. Epub 2015 Feb 11.
- Background: PubMed 20605308Linkevicius T, Apse P, Grybauskas S, Puisys A. Influence of thin mucosal tissues on crestal bone stability around implants with platform switching: a 1-year pilot study. J Oral Maxillofac Surg. 2010 Sep;68(9):2272-7. doi: 10.1016/j.joms.2009.08.018.
- Individual participant dataSharing planned: No
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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.
Claudio Stacchi, Dr. principal investigator
Piezosurgery Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implant insertion, operculectomy and prosthetic rehabilitation in people with Alveolar Bone Loss, run by International Piezosurgery Academy at 1 site in Italy.
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 0 inclusion and 12 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 28 Aug 2019. 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 Italy. 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?
peri-implant bone resorption (time frame: after 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03229005, which also lists 2 linked publications.
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 28 Aug 2019.