Bone Implant; ComplicationsIBPTHPIBCNCT05632172
Buccal and Palatal Bone Thickness and Marginal Bone Changes Implants
An observational study of Bone Implant; Complications, run by International Piezosurgery Academy at 2 sites in Italy.
Trial summary
The primary outcome of the study was the vertical variation of peri-implant buccal and palatal bone level from implant placement (T0) to uncovering stage (3 months later - T1) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Implant; Complications
- What is being tested?
- implant insertion
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 2 sitesItaly
- Study dates
- 15 Jan 2021to 15 Sep 2021
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Any patient presenting a single edentulism in the upper premolar area and requiring implant-prosthetic rehabilitation was eligible for this study. Furthermore, patients have to comply with the following inclusion and exclusion criteria.
Who may be able to join
- age > 18 years;
- no smokers;
- no history of periodontal disease;
- healed bone crest (at least six months after tooth extraction);
- crestal bone height ≥8 mm;
- crestal bone with a minimum bucco-palatal width of 6 mm with no concomitant or previous bone augmentation procedures.
Who cannot join
- absolute contraindications to implant surgery
- immunological or genetic disorders;
- uncontrolled diabetes (HBA1c > 7.5%);
- present or past treatment with anti resorptive drugs;
- oncologic patients;
- history of head or neck radiotherapy;
- alcohol or drugs abuse;
- final insertion torque > 50 Ncm.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Influence of Buccal and Palatal Bone Thickness on Post-surgical Marginal Bone Changes Around Implants Placed in Posterior Maxilla
The primary outcome of the study was the vertical variation of peri-implant buccal and palatal bone level from implant placement (T0) to uncovering stage (3 months later - T1)
Read the detailed description
despite various recommendations, there is insufficient evidence to set a threshold for minimal buccal bone thickness necessary to ensure peri-implant marginal bone stability and optimal aesthetic outcomes.
Therefore, the aim of the present multi-centre prospective study was to investigate the influence of buccal and palatal bone thickness at the time of implant placement on peri-implant bone remodeling during the submerged healing period, with a strict control of possible confounding factors.
- Conditions
- Bone Implant; Complications
- Being tested
- implant insertion
- Keywords
- implant, peri-implant bone remodeling, posterior maxilla, bone thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant insertionProcedure or surgery
bone level dental implant insertion
| Study group | Role | What they receive |
|---|---|---|
| maxillary group | implant insertion Receives: Procedure: implant insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
peri-implant bone changes in width buccal
measurement after implant site preparation with a caliper
Measured: three months after surgery
peri-implant bone changes in width palatal
measurement after implant site preparation with a caliper
Measured: three months after surgery
peri-implant bone changes in height buccal
measurement after implant insertion with a probe
Measured: three months after surgery
peri-implant bone changes in height palatal
measurement after implant insertion with a probe
Measured: three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start15 Jan 2021
- Primary completion15 Jul 2021
- Study completion15 Sep 2021
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 Bone Implant; ComplicationsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Piezosurgery Academy
- Sponsor type
- University, hospital or other
- Collaborators
- University of Trieste, University of Messina, University of Campania Luigi Vanvitelli
- Responsible party
- Sponsor
- Investigators
- Claudio Stacchi, Dr, Study chair, Piezoelectric Surgery Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632172
- Sponsor's protocol ID
- maxillary contraction
- Acronym
- IBPTHPIBC
- Status last verified
- Nov 2022
- First submitted
- 20 Nov 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Merheb J, Quirynen M, Teughels W. Critical buccal bone dimensions along implants. Periodontol 2000. 2014 Oct;66(1):97-105. doi: 10.1111/prd.12042.
PubMed 25123763Cicciu M, Pratella U, Fiorillo L, Bernardello F, Perillo F, Rapani A, Stacchi C, Lombardi T. Influence of buccal and palatal bone thickness on post-surgical marginal bone changes around implants placed in posterior maxilla: a multi-centre prospective study. BMC Oral Health. 2023 May 22;23(1):309. doi: 10.1186/s12903-023-02991-3.
PubMed 37217911
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Buccal and Palatal Bone Thickness on Post-surgical Marginal Bone Changes Around Implants Placed in Posterior Maxilla
- ClinicalTrials.gov ID
- NCT05632172
- Acronym / sponsor ID
- IBPTHPIBC / maxillary contraction
- Conditions
- Bone Implant; Complications
- Keywords
- implant, peri-implant bone remodeling, posterior maxilla, bone thickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- International Piezosurgery AcademyUniversity, hospital or other
- Collaborators
- University of Trieste, University of Messina, University of Campania Luigi Vanvitelli
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 30 Nov 2022 (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 primary outcome of the study was the vertical variation of peri-implant buccal and palatal bone level from implant placement (T0) to uncovering stage (3 months later - T1)
Detailed description
despite various recommendations, there is insufficient evidence to set a threshold for minimal buccal bone thickness necessary to ensure peri-implant marginal bone stability and optimal aesthetic outcomes.
Therefore, the aim of the present multi-centre prospective study was to investigate the influence of buccal and palatal bone thickness at the time of implant placement on peri-implant bone remodeling during the submerged healing period, with a strict control of possible confounding factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| maxillary group | – | Procedure: implant insertionimplant insertion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Any patient presenting a single edentulism in the upper premolar area and requiring implant-prosthetic rehabilitation was eligible for this study. Furthermore, patients have to comply with the following inclusion and exclusion criteria.
Key inclusion criteria (6 listed)
- age > 18 years;
- no smokers;
- no history of periodontal disease;
- healed bone crest (at least six months after tooth extraction);
- crestal bone height ≥8 mm;
Key exclusion criteria (8 listed)
- absolute contraindications to implant surgery
- immunological or genetic disorders;
- uncontrolled diabetes (HBA1c > 7.5%);
- present or past treatment with anti resorptive drugs;
- oncologic patients;
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 insertionbone level dental implant insertion | Procedure or surgery | maxillary group |
Primary outcome
peri-implant bone changes in width buccal
Time frame: three months after surgery
measurement after implant site preparation with a caliper
peri-implant bone changes in width palatal
Time frame: three months after surgery
measurement after implant site preparation with a caliper
peri-implant bone changes in height buccal
Time frame: three months after surgery
measurement after implant insertion with a probe
peri-implant bone changes in height palatal
Time frame: three months after surgery
measurement after implant insertion with a probe
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 30 Nov 2022.
- Results publication: PubMed 25123763Merheb J, Quirynen M, Teughels W. Critical buccal bone dimensions along implants. Periodontol 2000. 2014 Oct;66(1):97-105. doi: 10.1111/prd.12042.
- Derived from this study: PubMed 37217911Cicciu M, Pratella U, Fiorillo L, Bernardello F, Perillo F, Rapani A, Stacchi C, Lombardi T. Influence of buccal and palatal bone thickness on post-surgical marginal bone changes around implants placed in posterior maxilla: a multi-centre prospective study. BMC Oral Health. 2023 May 22;23(1):309. doi: 10.1186/s12903-023-02991-3.
- Individual participant dataSharing planned: No
Related trials for Bone Implant; Complications
Recruiting
Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty
Osteoporosis, Arthroplasty Complications
RecruitingObservational study
Evaluation of the Correlation Between Bone Tunnel Projection Placement and Clinical Outcomes in Anterior Cruciate Ligament Reconstruction Surgery
Anterior Cruciate Ligament Injury, Tunneling Technique
Active, not recruitingObservational study
Ultrasound for Socket Healing Evaluation
Healing Wound, Alveolar; Wound
Active, not recruitingObservational study
Local and Systemic Inflammatory Bone Alterations Related to Dental Implant Survival.
Peri Implant Mucositis, Peri Implant Bone Loss
RecruitingObservational study
Analysis of Intramedullary Nail and Prosthetic Reconstruction After Surgical Treatment of Bone Metastases of Proximal Femur
Bone Metastases
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 study chair
Piezoelectric Surgery Academy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Implant; Complications, run by International Piezosurgery Academy at 2 sites 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 6 inclusion and 8 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 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 changes in width buccal (time frame: three months after surgery). The study lists 4 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 NCT05632172, 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 30 Nov 2022.