Marginal Bone LossNCT05010382
Efficacy of Implant Surface Characteristics in Patients With History of Periodontitis
A study testing Implant placement surgery in people with Marginal Bone Loss, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
The aim of the study is to evaluate in patients with history of periodontitis the clinical, microbiological and radiological outcomes of implants with a modified implant design consisting on a machined surface in the coronal third of the implant. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Marginal Bone Loss
- What is being tested?
- Implant placement surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 13 Mar 2018to 25 Jul 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •> 20 years of age
- Presence of ≥1 adjacent missing teeth, in either maxilla or mandible (up to three missing units).
- A natural tooth had to be present mesially to the most proximal implant site, although free end situations were allowed, and opposing dentition had to be natural teeth or implant supported fixed restorations.
- History of treated and controlled periodontitis.
- Presence of adequate bone volume to achieve primary implant stability without concomitant regeneration
Who cannot join
- Diseases affecting bone metabolism or wound healing (e.g.)
- History of radiation therapy, leukocyte dysfunction, or any other immunodeficiency
- Drug abuse
- Intrasurgical exclusion criteria, such as the lack of primary stability, the need of bone augmentation or the impossibility of placing the implant based on prosthetic requirements. �
Trial locations and contacts
1 site in 1 country.
Spain1 site
Facultad de odontología, Complutense University of Madrid
Madrid, 28040
About this study
Official title: Efficacy of Two Dental Implants With Different Surface Characteristics in Patients With History of Periodontitis. A Randomized Controlled Clinical Trial.
The aim of the study is to evaluate in patients with history of periodontitis the clinical, microbiological and radiological outcomes of implants with a modified implant design consisting on a machined surface in the coronal third of the implant.
In this 12-month, parallel-arm, randomized controlled trial, patients with history of treated periodontitis and in need of dental implants for single-unit or short edentulous spaces (i.e. two implants) will be randomly assigned to a test group (implants with a hybrid surface, presenting a machined coronal third; HS) or a control group (conventional moderately rough implants; RS). Implants will be restored 3 months later with fixed implant supported reconstructions. Radiological, clinical, microbiological and patient-related outcome measures (PROMs) will be assessed 3, 6 and 12 months after the prosthetic installation.
- Conditions
- Marginal Bone Loss
- Being tested
- Implant placement surgery
- Keywords
- Implant surface, hybrid, Peri-implantitis, Periodontitis, Marginal bone loss
- Medical subject headings
- Peri-Implantitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant placement surgeryProcedure or surgery
Under local anaesthesia, full-thickness mucoperiosteal flaps were elevated, the alveolar ridge measured, and a proper implant dimension (3.75 mm and 4.25 mm diameter; 8 mm, 10 mm and 11.5 mm length) and position selected. After site preparation, each patient was randomly allocated to the test or the control group. Patients in the test group received a modified implant design with the coronal third presenting a machined surface (hybrid surface (HS) group), while in the control group the same implant design with a titanium rough surface up to the implant shoulder was used (rough surface (RS) group). Implants were placed 1 mm sub-crestally. In the case of dehiscence or fenestrations around the implant, the patient was excluded from the study. Once inserted, healing abutments (ranging between 3 -5 mm) were placed, and flaps sutured around the abutments to allow for a transmucosal healing.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Hybrid surface dental implant Receives: Procedure: Implant placement surgery |
| Control group | Experimental | moderately rough surface implant Receives: Procedure: Implant placement surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic marginal bone levels Change
Radiographic marginal bone levels (bone loss) are defined as the distance between the bone crest and the implant shoulder at mesial and distal sites.
For standardization of periapical radiographs the same film holder-beam aiming device will be applied (Rinn System) and silicone custom-made bite blocks will be used to improve reproducible repositioning. All digital radiographs will be evaluated by one calibrated and trained researcher (BS) using a software (AutoCAD® Autodesk ®, California, USA) that allows to calibrate the distances using the known implant length.
Measured: Change between baseline and 12 months
Secondary outcomes (3)
Clinical periodontal outcome measurements change
Clinical measurements will be performed at six sites per implant of i) probing depth (PD), ii) marginal mucosa recession assessed as length of the implant crown (CLI; distance from the mucosal margin to the oclusal surface at the mid buccal point), iii) bleeding on probing (BoP) and iv) plaque scores (PI). Finally, peri-implant mucositis, defined as the presence of profuse BoP.
Measured: Change between baseline and 12 months
Microbiologic outcome measurements change
Paper points will be inserted to the depth of the peri-implant pocket and kept in place for 15 sec. The points will be transferred into a screw-capped vial, containing 1.5 ml of reduced transport fluid, (RTF) and maintained at -20ºC. Microbiological analysis by means of anaerobic culture will be performed for the determination of counts, proportion and frequency of detection of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Prevotella intermedia and Fusobacterium nucleatum.�
Measured: Change between baseline and 12 months
Patient reported outcome measures (PROM's)change
PROM´s will be assessed by means of a questionnaire comprising 4 items: comfort, appearance, masticatory function and overall satisfaction. Patients will be asked to rate these four aspects according to the following scale: very unsatisfied, unsatisfied, fair, satisfied and very satisfied.
Measured: Change between baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start13 Mar 2018
- Primary completion25 Jul 2021
- Study completion25 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Marginal Bone LossStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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
- Patients will recieve an implant with either hybrid surface (test group) or moderately rough surface (control implants
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Ti Care S.L
- Responsible party
- Principal investigator, Benjamín Serrano Torrecilla, Universidad Complutense de Madrid
- Investigators
- Mariano Sanz Alonso, Chair, Study chair, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010382
- Sponsor's protocol ID
- 17.516-R_P
- Status last verified
- Aug 2021
- First submitted
- 3 Aug 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buser D, Sennerby L, De Bruyn H. Modern implant dentistry based on osseointegration: 50 years of progress, current trends and open questions. Periodontol 2000. 2017 Feb;73(1):7-21. doi: 10.1111/prd.12185.
PubMed 28000280Cochran DL. A comparison of endosseous dental implant surfaces. J Periodontol. 1999 Dec;70(12):1523-39. doi: 10.1902/jop.1999.70.12.1523.
PubMed 10632528Polizzi G, Gualini F, Friberg B. A two-center retrospective analysis of long-term clinical and radiologic data of TiUnite and turned implants placed in the same mouth. Int J Prosthodont. 2013 Jul-Aug;26(4):350-8. doi: 10.11607/ijp.3386.
PubMed 23837166John G, Becker J, Schwarz F. Modified implant surface with slower and less initial biofilm formation. Clin Implant Dent Relat Res. 2015 Jun;17(3):461-8. doi: 10.1111/cid.12140. Epub 2013 Aug 27.
PubMed 23981274Teughels W, Van Assche N, Sliepen I, Quirynen M. Effect of material characteristics and/or surface topography on biofilm development. Clin Oral Implants Res. 2006 Oct;17 Suppl 2:68-81. doi: 10.1111/j.1600-0501.2006.01353.x.
PubMed 16968383Esposito M, Murray-Curtis L, Grusovin MG, Coulthard P, Worthington HV. Interventions for replacing missing teeth: different types of dental implants. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003815. doi: 10.1002/14651858.CD003815.pub3.
PubMed 17943800Albouy JP, Abrahamsson I, Berglundh T. Spontaneous progression of experimental peri-implantitis at implants with different surface characteristics: an experimental study in dogs. J Clin Periodontol. 2012 Feb;39(2):182-7. doi: 10.1111/j.1600-051X.2011.01820.x. Epub 2011 Dec 4.
PubMed 22136592Albouy JP, Abrahamsson I, Persson LG, Berglundh T. Spontaneous progression of peri-implantitis at different types of implants. An experimental study in dogs. I: clinical and radiographic observations. Clin Oral Implants Res. 2008 Oct;19(10):997-1002. doi: 10.1111/j.1600-0501.2008.01589.x.
PubMed 18828815Albouy JP, Abrahamsson I, Persson LG, Berglundh T. Implant surface characteristics influence the outcome of treatment of peri-implantitis: an experimental study in dogs. J Clin Periodontol. 2011 Jan;38(1):58-64. doi: 10.1111/j.1600-051X.2010.01631.x. Epub 2010 Nov 24.
PubMed 21092053Donati M, Ekestubbe A, Lindhe J, Wennstrom JL. Marginal bone loss at implants with different surface characteristics - A 20-year follow-up of a randomized controlled clinical trial. Clin Oral Implants Res. 2018 May;29(5):480-487. doi: 10.1111/clr.13145. Epub 2018 Mar 23.
PubMed 29569767Wennstrom JL, Ekestubbe A, Grondahl K, Karlsson S, Lindhe J. Oral rehabilitation with implant-supported fixed partial dentures in periodontitis-susceptible subjects. A 5-year prospective study. J Clin Periodontol. 2004 Sep;31(9):713-24. doi: 10.1111/j.1600-051X.2004.00568.x.
PubMed 15312092Aglietta M, Siciliano VI, Rasperini G, Cafiero C, Lang NP, Salvi GE. A 10-year retrospective analysis of marginal bone-level changes around implants in periodontally healthy and periodontally compromised tobacco smokers. Clin Oral Implants Res. 2011 Jan;22(1):47-53. doi: 10.1111/j.1600-0501.2010.01977.x. Epub 2010 Sep 10.
PubMed 20831754Hinode D, Tanabe S, Yokoyama M, Fujisawa K, Yamauchi E, Miyamoto Y. Influence of smoking on osseointegrated implant failure: a meta-analysis. Clin Oral Implants Res. 2006 Aug;17(4):473-8. doi: 10.1111/j.1600-0501.2005.01244.x.
PubMed 16907781Roccuzzo M, Bonino F, Aglietta M, Dalmasso P. Ten-year results of a three arms prospective cohort study on implants in periodontally compromised patients. Part 2: clinical results. Clin Oral Implants Res. 2012 Apr;23(4):389-95. doi: 10.1111/j.1600-0501.2011.02309.x. Epub 2011 Sep 28.
PubMed 22092445Matarasso S, Rasperini G, Iorio Siciliano V, Salvi GE, Lang NP, Aglietta M. A 10-year retrospective analysis of radiographic bone-level changes of implants supporting single-unit crowns in periodontally compromised vs. periodontally healthy patients. Clin Oral Implants Res. 2010 Sep;21(9):898-903. doi: 10.1111/j.1600-0501.2010.01945.x. Epub 2010 Apr 20.
PubMed 20438576
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Two Dental Implants With Different Surface Characteristics in Patients With History of Periodontitis. A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT05010382
- Acronym / sponsor ID
- 17.516-R_P
- Conditions
- Marginal Bone Loss
- Keywords
- Implant surface, hybrid, Peri-implantitis, Periodontitis, Marginal bone loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Ti Care S.L
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 25 Jul 2021 (actual)
- Study completion
- 25 Jul 2021 (actual)
- First posted
- 18 Aug 2021 (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 aim of the study is to evaluate in patients with history of periodontitis the clinical, microbiological and radiological outcomes of implants with a modified implant design consisting on a machined surface in the coronal third of the implant.
In this 12-month, parallel-arm, randomized controlled trial, patients with history of treated periodontitis and in need of dental implants for single-unit or short edentulous spaces (i.e. two implants) will be randomly assigned to a test group (implants with a hybrid surface, presenting a machined coronal third; HS) or a control group (conventional moderately rough implants; RS). Implants will be restored 3 months later with fixed implant supported reconstructions. Radiological, clinical, microbiological and patient-related outcome measures (PROMs) will be assessed 3, 6 and 12 months after the prosthetic installation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will recieve an implant with either hybrid surface (test group) or moderately rough surface (control implants
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: Implant placement surgeryHybrid surface dental implant |
| Control group | Experimental | Procedure: Implant placement surgerymoderately rough surface implant |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- •> 20 years of age
- Presence of ≥1 adjacent missing teeth, in either maxilla or mandible (up to three missing units).
- A natural tooth had to be present mesially to the most proximal implant site, although free end situations were allowed, and opposing dentition had to be natural teeth or implant supported fixed restorations.
- History of treated and controlled periodontitis.
- Presence of adequate bone volume to achieve primary implant stability without concomitant regeneration
Key exclusion criteria (4 listed)
- Diseases affecting bone metabolism or wound healing (e.g.)
- History of radiation therapy, leukocyte dysfunction, or any other immunodeficiency
- Drug abuse
- Intrasurgical exclusion criteria, such as the lack of primary stability, the need of bone augmentation or the impossibility of placing the implant based on prosthetic requirements. �
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 placement surgeryUnder local anaesthesia, full-thickness mucoperiosteal flaps were elevated, the alveolar ridge measured, and a proper implant dimension (3.75 mm and 4.25 mm diameter; 8 mm, 10 mm and 11.5 mm length) and position selected. After site preparation, each patient was randomly allocated to the test or the control group. Patients in the test group received a modified implant design with the coronal third presenting a machined surface (hybrid surface (HS) group), while in the control group the same implant design with a titanium rough surface up to the implant shoulder was used (rough surface (RS) group). Implants were placed 1 mm sub-crestally. In the case of dehiscence or fenestrations around the implant, the patient was excluded from the study. Once inserted, healing abutments (ranging between 3 -5 mm) were placed, and flaps sutured around the abutments to allow for a transmucosal healing. | Procedure or surgery | Control group, Test group |
Primary outcome
Radiographic marginal bone levels Change
Time frame: Change between baseline and 12 months
Radiographic marginal bone levels (bone loss) are defined as the distance between the bone crest and the implant shoulder at mesial and distal sites. For standardization of periapical radiographs the same film holder-beam aiming device will be applied (Rinn System) and silicone custom-made bite blocks will be used to improve reproducible repositioning. All digital radiographs will be evaluated by one calibrated and trained researcher (BS) using a software (AutoCAD® Autodesk ®, California, USA) that allows to calibrate the distances using the known implant length.
3 secondary outcomes
Clinical periodontal outcome measurements change
Time frame: Change between baseline and 12 months
Microbiologic outcome measurements change
Time frame: Change between baseline and 12 months
Patient reported outcome measures (PROM's)change
Time frame: Change between baseline and 12 months
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 18 Aug 2021.
- Background: PubMed 28000280Buser D, Sennerby L, De Bruyn H. Modern implant dentistry based on osseointegration: 50 years of progress, current trends and open questions. Periodontol 2000. 2017 Feb;73(1):7-21. doi: 10.1111/prd.12185.
- Background: PubMed 10632528Cochran DL. A comparison of endosseous dental implant surfaces. J Periodontol. 1999 Dec;70(12):1523-39. doi: 10.1902/jop.1999.70.12.1523.
- Background: PubMed 23837166Polizzi G, Gualini F, Friberg B. A two-center retrospective analysis of long-term clinical and radiologic data of TiUnite and turned implants placed in the same mouth. Int J Prosthodont. 2013 Jul-Aug;26(4):350-8. doi: 10.11607/ijp.3386.
- Background: PubMed 23981274John G, Becker J, Schwarz F. Modified implant surface with slower and less initial biofilm formation. Clin Implant Dent Relat Res. 2015 Jun;17(3):461-8. doi: 10.1111/cid.12140. Epub 2013 Aug 27.
- Background: PubMed 16968383Teughels W, Van Assche N, Sliepen I, Quirynen M. Effect of material characteristics and/or surface topography on biofilm development. Clin Oral Implants Res. 2006 Oct;17 Suppl 2:68-81. doi: 10.1111/j.1600-0501.2006.01353.x.
- Background: PubMed 17943800Esposito M, Murray-Curtis L, Grusovin MG, Coulthard P, Worthington HV. Interventions for replacing missing teeth: different types of dental implants. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003815. doi: 10.1002/14651858.CD003815.pub3.
- Background: PubMed 22136592Albouy JP, Abrahamsson I, Berglundh T. Spontaneous progression of experimental peri-implantitis at implants with different surface characteristics: an experimental study in dogs. J Clin Periodontol. 2012 Feb;39(2):182-7. doi: 10.1111/j.1600-051X.2011.01820.x. Epub 2011 Dec 4.
- Background: PubMed 18828815Albouy JP, Abrahamsson I, Persson LG, Berglundh T. Spontaneous progression of peri-implantitis at different types of implants. An experimental study in dogs. I: clinical and radiographic observations. Clin Oral Implants Res. 2008 Oct;19(10):997-1002. doi: 10.1111/j.1600-0501.2008.01589.x.
- Background: PubMed 21092053Albouy JP, Abrahamsson I, Persson LG, Berglundh T. Implant surface characteristics influence the outcome of treatment of peri-implantitis: an experimental study in dogs. J Clin Periodontol. 2011 Jan;38(1):58-64. doi: 10.1111/j.1600-051X.2010.01631.x. Epub 2010 Nov 24.
- Background: PubMed 29569767Donati M, Ekestubbe A, Lindhe J, Wennstrom JL. Marginal bone loss at implants with different surface characteristics - A 20-year follow-up of a randomized controlled clinical trial. Clin Oral Implants Res. 2018 May;29(5):480-487. doi: 10.1111/clr.13145. Epub 2018 Mar 23.
- Background: PubMed 15312092Wennstrom JL, Ekestubbe A, Grondahl K, Karlsson S, Lindhe J. Oral rehabilitation with implant-supported fixed partial dentures in periodontitis-susceptible subjects. A 5-year prospective study. J Clin Periodontol. 2004 Sep;31(9):713-24. doi: 10.1111/j.1600-051X.2004.00568.x.
- Background: PubMed 20831754Aglietta M, Siciliano VI, Rasperini G, Cafiero C, Lang NP, Salvi GE. A 10-year retrospective analysis of marginal bone-level changes around implants in periodontally healthy and periodontally compromised tobacco smokers. Clin Oral Implants Res. 2011 Jan;22(1):47-53. doi: 10.1111/j.1600-0501.2010.01977.x. Epub 2010 Sep 10.
- 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.
Mariano Sanz Alonso, Chair study chair
Universidad Complutense de Madrid
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 placement surgery in people with Marginal Bone Loss, run by Universidad Complutense de Madrid 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 5 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 18 Aug 2021. 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?
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?
Radiographic marginal bone levels Change (time frame: Change between baseline and 12 months). 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 NCT05010382, which also lists 21 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 18 Aug 2021.