Dental ImplantNCT04328051
Influence of the Implant-prosthetic Connection in the Marginal Bone Loss and Bacterial Leakage
A study testing Dental Implant Placement in people with Dental Implant and Bone Loss, run by University of Barcelona at 1 site in Spain.
Trial summary
This study consists in a double-blinded randomized controlled trial which objective is to assess the effect of the implant-abutment connection type -external hexagon, internal hexagon and conical connection- in the periimplant marginal bone loss in vertical side and the bacterial leakage 12 months after prosthesis… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant, Bone Loss, Bacterial Infections
- What is being tested?
- Dental Implant Placement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jun 2018to 13 Dec 2021
- 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
- Subjects who accept signing voluntarily the informed consent before doing any action related to the study.
- ≥18-years-old patients.
- Edentulous single spaces or edentulous posterior maxilla or mandible (from the first premolar to the second molar) with screw-retained single fixed crowns.
- Single implants successfully osseointegrated placed at least 16 weeks post-extraction.
- O'Leary plaque index and or bleeding on probing ≤25%.
- Dental implants with screwed-retained prosthesis.
Who cannot join
- Systemic diseases that can interfere dental implant placement.
- Any contraindication for surgery procedures.
- Heavy smokers (> 20cig/day).
- Background of drug abuse or other factors such as psychiatric diseases that, in opinion of the examiner, could interfere with the ability of the patient to cooperate and compliment with the study.
- Patients who have had participated with another clinical trial the last 30 days.
- Pregnant women or in lactation.
Show all 9Show fewer
- Patients with bad oral hygiene or not motivated.
- Probing pockets depths with bleeding of ≥4 mm on a tooth adjacent to the edentulous space.
- Guided bone regeneration required in the same time of the implant placement.
Trial locations and contacts
1 site in 1 country.
Octavi J. Camps-Font, DDS, MS contact
Spain1 site, 1 recruiting
- Recruiting
University of Barcelona
L'Hospitalet de Llobregat, Catalonia, 08903
Octavi Camps-Font, DDS, MS, +34665980569, occafo@gmail.com
Rui Figueiredo, DDS, MS, PhD, +34667378126, ruipfigueiredo@hotmail.com
About this study
Official title: Influence of the Implant-prosthetic Connection in the Marginal Bone Loss and Bacterial Leakage. A Randomized Controlled Trial
This study consists in a double-blinded randomized controlled trial which objective is to assess the effect of the implant-abutment connection type -external hexagon, internal hexagon and conical connection- in the periimplant marginal bone loss in vertical side and the bacterial leakage 12 months after prosthesis placement.
Read the detailed description
Location: This study is going to take place in the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge).
Study subjects: The sample (105 patients) consists of patients with single tooth edentulous spaces or posterior maxillary and/or mandible edentulous spaces in need of dental implants with screw-retained single fixed crowns. All of them are being properly informed about the study according to the Comité Ético (CEIC) del Hospital Odontològic Universitat de Barcelona guidelines, and informed consent must be signed prior to the interventions.
Material: Registration papers for the study, dental implants, surgery material, prosthetic components, Florida Probe Software®, Periapical x-rays, computer, Software Stata 14 and Software ImageJ®.
Determinations: Clinical, radiographic and microbiologic measures since implant placement, prosthesis placement and 3, 6, 9 and 12 months after it.
- Conditions
- Dental Implant, Bone Loss, Bacterial Infections
- Being tested
- Dental Implant Placement
- Keywords
- Dental Implant, Internal Connection, External Connection, Conical Connection, Marginal Bone Loss, Implant Prosthetic Connection, Bacterial Leakage
- Medical subject headings
- Bone Diseases, Metabolic, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Implant PlacementOther
Also called Surgery
Antibiotic prophylaxis will be done. After rinsing with 0.12 % chlorhexidine, patients will receive local anaesthesia. A crestal incision will be done and a mucoperiostic flap will be raised. As the commercial specifies, progressive diameter drills will be used under constant sterile saline irrigation to prepare the implant site. Once finished the drilling sequence, one investigator will open the opaque envelope to know which type of implant, depending on the connection, has to be placed by the surgeon. Dental implant will be placed crestally and depending if it has primary stability or not, it will be leaded submerged or non-submerged. The flap will be repositioned and sutured without tension with 4/0 polyamide. Postoperative instructions and medication will be prescribed and explained.
| Study group | Role | What they receive |
|---|---|---|
| Ocean E.C.®, Avinent Implant System S.L. | Active comparator | Dental implant with geometry adapted to the biologic architecture of the bone, with platform switching with a positive angle and machined surface with micro-threads in the cervical region. Asymmetric and progressive threads in its body with a double thread pitch. Point-ratio geometry on its apical region, Biomimetic Advanced Surface and external hexagon connection. Receives: Other: Dental Implant Placement |
| Ocean I.C.®, Avinent Implant System S.L. | Active comparator | Dental implant with geometry adapted to the biologic architecture of the bone, with platform switching with a positive angle and machined surface with micro-threads in the cervical region. Asymmetric and progressive threads in its body with a double thread pitch. Point-ratio geometry on its apical region, Biomimetic Advanced Surface and internal hexagon connection. Receives: Other: Dental Implant Placement |
| Ocean C.C.®, Avinent Implant System S.L. | Active comparator | Dental implant with geometry adapted to the biologic architecture of the bone, with platform switching with a positive angle and machined surface with micro-threads in the cervical region. Asymmetric and progressive threads in its body with a double thread pitch. Point-ratio geometry on its apical region, Biomimetic Advanced Surface and conical connection. Receives: Other: Dental Implant Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vertical Marginal Bone Loss (VMBL)
Distance in millimetres between the implant platform and the point of the intra-bone defect that is more apical.
Measured: Since implant placement (Timing 0) through study completion (Timing 5), an average of 1 year.
Secondary outcomes (12)
Vertical Marginal Bone Loss Tax
Vertical bone loss in millimetres per implant and unit of time.
Measured: 12 months after prosthesis placement.
Early implant failure
Implant with mobility or failure of the osseointegration process before the prosthesis placement.
Measured: Since implant placement (Timing 0) through prosthesis placement (Timing 1).
Late implant failure
Implant with mobility or failure of the osseointegration process after the prosthesis placement.
Measured: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Probing pocket depth
Distance in millimetres from the gingival margin to the bottom of the periodontal pocket measured with the periodontal probe. Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal).
Measured: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Mucosal recession
Distance in millimetres from the cemento-enamel junction of the tooth or from the implant platform to the gingival margin when it is located apically. Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal).
Measured: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Mucosal hyperplasia
Distance in millimetres from the gingival margin to the cemento-enamel junction of the tooth or to the implant platform when the gingiva is located more coronal than them. Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal).
Measured: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Clinical attachment level
Probing pocket depth (mm) plus the recession (mm) or probing pocket depth minus the hyperplasia (mm). Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal).
Measured: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
O'Leary plaque index
Plaque presence in the dentogingival or implantogingival union. Determined in four points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual). Expressed as the percentage (%) of tooth or implant surfaces with plaque presence divided with the total of tooth or implant surfaces in mouth and multiplied per 100.
Measured: First visit
Bleeding on probing
Presence of blood in the gingival margin after determining the probing pocket depth. Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal). Expressed as the percentage (%) of tooth or implant surfaces with blood divided with the total of tooth or implant surfaces in mouth and multiplied per 100.
Measured: Since first visit through study completion (Timing 5), an average of 1 year.
Suppuration on probing
Presence of purulent material in the gingival margin after determining the probing pocket depth. Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal). Expressed as the percentage (%) of tooth or implant surfaces with pus divided with the total of tooth or implant surfaces in mouth and multiplied per 100.
Measured: Since first visit through study completion (Timing 5), an average of 1 year.
Prosthetic complications
Screw (which connects the crown with the implant) fracture or prosthesis fracture, chipping of the ceramic prosthesis, loosening of the screw (which connects the crown with the implant) or any other prosthetic components.
Measured: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Bacterial leakage
Quantitative PCR in real time to determine the total amount of bacteria and in particular, of 10 pathogenic species: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythensis, Treponema denticola, Prevotella intermedia, Peptostreptococcus micros, Fusobacterium nucleatum, Campylobacter rectus, Eikenella corrodens and Candida albicans.
Measured: 12 months after prosthesis placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start13 Jun 2018
- Primary completion13 Jun 2021 (estimated)
- Study completion13 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantStudies 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
- Model description
- Active comparator: Ocean E.C.®, Avinent Implant System S.L., Santpedor, Spain. Active comparator: Ocean I.C.®, Avinent Implant System S.L., Santpedor, Spain. Active comparator: Ocean C.C.®, Avinent Implant System S.L., Santpedor, Spain.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Octavi Camps-Font, University of Barcelona
- Investigators
- Rui Figueiredo, DDS, MS, PhD, Study director, University of BarcelonaEduard Valmaseda-Castellón, DDS, MS, PhD, Study chair, University of BarcelonaOctavi Camps-Font, DDS, MS, Principal investigator, University of BarcelonaRoxana Ghiorghiu, DDS, MS, Principal investigator, University of BarcelonaLaura Rubianes-Porta, DDS, MS, Principal investigator, University of BarcelonaAnna Piñol-Olea, DDS, MS, Principal investigator, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328051
- Sponsor's protocol ID
- UBarcelonaOralSurgery2
- Status last verified
- Mar 2020
- First submitted
- 21 Jun 2018
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Under request
Publications
Branemark PI, Adell R, Breine U, Hansson BO, Lindstrom J, Ohlsson A. Intra-osseous anchorage of dental prostheses. I. Experimental studies. Scand J Plast Reconstr Surg. 1969;3(2):81-100. doi: 10.3109/02844316909036699. No abstract available.
PubMed 4924041Albrektsson T, Donos N; Working Group 1. Implant survival and complications. The Third EAO consensus conference 2012. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:63-5. doi: 10.1111/j.1600-0501.2012.02557.x.
PubMed 23062128Derks J, Tomasi C. Peri-implant health and disease. A systematic review of current epidemiology. J Clin Periodontol. 2015 Apr;42 Suppl 16:S158-71. doi: 10.1111/jcpe.12334.
PubMed 25495683Buser D, Ingimarsson S, Dula K, Lussi A, Hirt HP, Belser UC. Long-term stability of osseointegrated implants in augmented bone: a 5-year prospective study in partially edentulous patients. Int J Periodontics Restorative Dent. 2002 Apr;22(2):109-17.
PubMed 12019706Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. No abstract available.
PubMed 3527955Oh TJ, Yoon J, Misch CE, Wang HL. The causes of early implant bone loss: myth or science? J Periodontol. 2002 Mar;73(3):322-33. doi: 10.1902/jop.2002.73.3.322.
PubMed 11922263Quirynen M, Naert I, van Steenberghe D. Fixture design and overload influence marginal bone loss and fixture success in the Branemark system. Clin Oral Implants Res. 1992 Sep;3(3):104-11. doi: 10.1034/j.1600-0501.1992.030302.x.
PubMed 1290790Malevez C, Hermans M, Daelemans P. Marginal bone levels at Branemark system implants used for single tooth restoration. The influence of implant design and anatomical region. Clin Oral Implants Res. 1996 Jun;7(2):162-9. doi: 10.1034/j.1600-0501.1996.070210.x.
PubMed 9002835Vidyasagar L, Apse P. Dental implant design and biological effects on bone implant interface. Baltic Dent Maxillofac J. 2004;6:51-4.
Isidor F. Influence of forces on peri-implant bone. Clin Oral Implants Res. 2006 Oct;17 Suppl 2:8-18. doi: 10.1111/j.1600-0501.2006.01360.x.
PubMed 16968378Abrahamsson I, Berglundh T. Effects of different implant surfaces and designs on marginal bone-level alterations: a review. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:207-15. doi: 10.1111/j.1600-0501.2009.01783.x.
PubMed 19663966Koo KT, Lee EJ, Kim JY, Seol YJ, Han JS, Kim TI, Lee YM, Ku Y, Wikesjo UM, Rhyu IC. The effect of internal versus external abutment connection modes on crestal bone changes around dental implants: a radiographic analysis. J Periodontol. 2012 Sep;83(9):1104-9. doi: 10.1902/jop.2011.110456. Epub 2011 Dec 6.
PubMed 22145806Nishioka RS, de Vasconcellos LG, de Melo Nishioka GN. Comparative strain gauge analysis of external and internal hexagon, Morse taper, and influence of straight and offset implant configuration. Implant Dent. 2011 Apr;20(2):e24-32. doi: 10.1097/ID.0b013e318211fce8.
PubMed 21448016Lin MI, Shen YW, Huang HL, Hsu JT, Fuh LJ. A retrospective study of implant-abutment connections on crestal bone level. J Dent Res. 2013 Dec;92(12 Suppl):202S-7S. doi: 10.1177/0022034513510322. Epub 2013 Oct 24.
PubMed 24158343Astrand P, Engquist B, Dahlgren S, Grondahl K, Engquist E, Feldmann H. Astra Tech and Branemark system implants: a 5-year prospective study of marginal bone reactions. Clin Oral Implants Res. 2004 Aug;15(4):413-20. doi: 10.1111/j.1600-0501.2004.01028.x.
PubMed 15248875
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Implant-prosthetic Connection in the Marginal Bone Loss and Bacterial Leakage. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04328051
- Acronym / sponsor ID
- UBarcelonaOralSurgery2
- Conditions
- Dental Implant, Bone Loss, Bacterial Infections
- Keywords
- Dental Implant, Internal Connection, External Connection, Conical Connection, Marginal Bone Loss, Implant Prosthetic Connection, Bacterial Leakage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 13 Jun 2021 (estimated)
- Study completion
- 13 Dec 2021 (estimated)
- First posted
- 31 Mar 2020 (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.
This study consists in a double-blinded randomized controlled trial which objective is to assess the effect of the implant-abutment connection type -external hexagon, internal hexagon and conical connection- in the periimplant marginal bone loss in vertical side and the bacterial leakage 12 months after prosthesis placement.
Detailed description
Location: This study is going to take place in the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge).
Study subjects: The sample (105 patients) consists of patients with single tooth edentulous spaces or posterior maxillary and/or mandible edentulous spaces in need of dental implants with screw-retained single fixed crowns. All of them are being properly informed about the study according to the Comité Ético (CEIC) del Hospital Odontològic Universitat de Barcelona guidelines, and informed consent must be signed prior to the interventions.
Material: Registration papers for the study, dental implants, surgery material, prosthetic components, Florida Probe Software®, Periapical x-rays, computer, Software Stata 14 and Software ImageJ®.
Determinations: Clinical, radiographic and microbiologic measures since implant placement, prosthesis placement and 3, 6, 9 and 12 months after it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Active comparator: Ocean E.C.®, Avinent Implant System S.L., Santpedor, Spain. Active comparator: Ocean I.C.®, Avinent Implant System S.L., Santpedor, Spain. Active comparator: Ocean C.C.®, Avinent Implant System S.L., Santpedor, Spain.
| Arm | Type | Receives |
|---|---|---|
| Ocean E.C.®, Avinent Implant System S.L. | Active comparator | Other: Dental Implant PlacementDental implant with geometry adapted to the biologic architecture of the bone, with platform switching with a positive angle and machined surface with micro-threads in the cervical region. Asymmetric and progressive threads in its body with a double thread pitch. Point-ratio geometry on its apical region, Biomimetic Advanced Surface and external hexagon connection. |
| Ocean I.C.®, Avinent Implant System S.L. | Active comparator | Other: Dental Implant PlacementDental implant with geometry adapted to the biologic architecture of the bone, with platform switching with a positive angle and machined surface with micro-threads in the cervical region. Asymmetric and progressive threads in its body with a double thread pitch. Point-ratio geometry on its apical region, Biomimetic Advanced Surface and internal hexagon connection. |
| Ocean C.C.®, Avinent Implant System S.L. | Active comparator | Other: Dental Implant PlacementDental implant with geometry adapted to the biologic architecture of the bone, with platform switching with a positive angle and machined surface with micro-threads in the cervical region. Asymmetric and progressive threads in its body with a double thread pitch. Point-ratio geometry on its apical region, Biomimetic Advanced Surface and conical connection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects who accept signing voluntarily the informed consent before doing any action related to the study.
- ≥18-years-old patients.
- Edentulous single spaces or edentulous posterior maxilla or mandible (from the first premolar to the second molar) with screw-retained single fixed crowns.
- Single implants successfully osseointegrated placed at least 16 weeks post-extraction.
- O'Leary plaque index and or bleeding on probing ≤25%.
Key exclusion criteria (9 listed)
- Systemic diseases that can interfere dental implant placement.
- Any contraindication for surgery procedures.
- Heavy smokers (> 20cig/day).
- Background of drug abuse or other factors such as psychiatric diseases that, in opinion of the examiner, could interfere with the ability of the patient to cooperate and compliment with the study.
- Patients who have had participated with another clinical trial the last 30 days.
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 |
|---|---|---|
| Dental Implant PlacementAlso: SurgeryAntibiotic prophylaxis will be done. After rinsing with 0.12 % chlorhexidine, patients will receive local anaesthesia. A crestal incision will be done and a mucoperiostic flap will be raised. As the commercial specifies, progressive diameter drills will be used under constant sterile saline irrigation to prepare the implant site. Once finished the drilling sequence, one investigator will open the opaque envelope to know which type of implant, depending on the connection, has to be placed by the surgeon. Dental implant will be placed crestally and depending if it has primary stability or not, it will be leaded submerged or non-submerged. The flap will be repositioned and sutured without tension with 4/0 polyamide. Postoperative instructions and medication will be prescribed and explained. | Other | Ocean C.C.®, Avinent Implant System S.L., Ocean E.C.®, Avinent Implant System S.L., Ocean I.C.®, Avinent Implant System S.L. |
Primary outcome
Change in Vertical Marginal Bone Loss (VMBL)
Time frame: Since implant placement (Timing 0) through study completion (Timing 5), an average of 1 year.
Distance in millimetres between the implant platform and the point of the intra-bone defect that is more apical.
12 secondary outcomes
Vertical Marginal Bone Loss Tax
Time frame: 12 months after prosthesis placement.
Early implant failure
Time frame: Since implant placement (Timing 0) through prosthesis placement (Timing 1).
Late implant failure
Time frame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Probing pocket depth
Time frame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Mucosal recession
Time frame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Mucosal hyperplasia
Time frame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Clinical attachment level
Time frame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
O'Leary plaque index
Time frame: First visit
Bleeding on probing
Time frame: Since first visit through study completion (Timing 5), an average of 1 year.
Suppuration on probing
Time frame: Since first visit through study completion (Timing 5), an average of 1 year.
Prosthetic complications
Time frame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Bacterial leakage
Time frame: 12 months after prosthesis placement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Background: PubMed 4924041Branemark PI, Adell R, Breine U, Hansson BO, Lindstrom J, Ohlsson A. Intra-osseous anchorage of dental prostheses. I. Experimental studies. Scand J Plast Reconstr Surg. 1969;3(2):81-100. doi: 10.3109/02844316909036699. No abstract available.
- Background: PubMed 23062128Albrektsson T, Donos N; Working Group 1. Implant survival and complications. The Third EAO consensus conference 2012. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:63-5. doi: 10.1111/j.1600-0501.2012.02557.x.
- Background: PubMed 25495683Derks J, Tomasi C. Peri-implant health and disease. A systematic review of current epidemiology. J Clin Periodontol. 2015 Apr;42 Suppl 16:S158-71. doi: 10.1111/jcpe.12334.
- Background: PubMed 12019706Buser D, Ingimarsson S, Dula K, Lussi A, Hirt HP, Belser UC. Long-term stability of osseointegrated implants in augmented bone: a 5-year prospective study in partially edentulous patients. Int J Periodontics Restorative Dent. 2002 Apr;22(2):109-17.
- Background: PubMed 3527955Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. No abstract available.
- Background: PubMed 11922263Oh TJ, Yoon J, Misch CE, Wang HL. The causes of early implant bone loss: myth or science? J Periodontol. 2002 Mar;73(3):322-33. doi: 10.1902/jop.2002.73.3.322.
- Background: PubMed 1290790Quirynen M, Naert I, van Steenberghe D. Fixture design and overload influence marginal bone loss and fixture success in the Branemark system. Clin Oral Implants Res. 1992 Sep;3(3):104-11. doi: 10.1034/j.1600-0501.1992.030302.x.
- Background: PubMed 9002835Malevez C, Hermans M, Daelemans P. Marginal bone levels at Branemark system implants used for single tooth restoration. The influence of implant design and anatomical region. Clin Oral Implants Res. 1996 Jun;7(2):162-9. doi: 10.1034/j.1600-0501.1996.070210.x.
- BackgroundVidyasagar L, Apse P. Dental implant design and biological effects on bone implant interface. Baltic Dent Maxillofac J. 2004;6:51-4.
- Background: PubMed 16968378Isidor F. Influence of forces on peri-implant bone. Clin Oral Implants Res. 2006 Oct;17 Suppl 2:8-18. doi: 10.1111/j.1600-0501.2006.01360.x.
- Background: PubMed 19663966Abrahamsson I, Berglundh T. Effects of different implant surfaces and designs on marginal bone-level alterations: a review. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:207-15. doi: 10.1111/j.1600-0501.2009.01783.x.
- Background: PubMed 22145806Koo KT, Lee EJ, Kim JY, Seol YJ, Han JS, Kim TI, Lee YM, Ku Y, Wikesjo UM, Rhyu IC. The effect of internal versus external abutment connection modes on crestal bone changes around dental implants: a radiographic analysis. J Periodontol. 2012 Sep;83(9):1104-9. doi: 10.1902/jop.2011.110456. Epub 2011 Dec 6.
- Individual participant dataSharing planned: No. Under request
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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.
Octavi J. Camps-Font, DDS, MS contact
Rui Figueiredo, DDS, MS, PhD study director
University of Barcelona
Eduard Valmaseda-Castellón, DDS, MS, PhD study chair
University of Barcelona
Octavi Camps-Font, DDS, MS principal investigator
University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Implant Placement in people with Dental Implant and Bone Loss, run by University of Barcelona at 1 site in Spain.
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 9 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: status not confirmed, as of the sponsor's last update on 31 Mar 2020. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Rubianes-Porta, DDS, MS (+34630873804, od074964@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vertical Marginal Bone Loss (VMBL) (time frame: Since implant placement (Timing 0) through study completion (Timing 5), an average of 1 year.). 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 NCT04328051, which also lists 15 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 31 Mar 2020.