Peri-ImplantitisNCT03900741
Guided Bone Regeneration of Peri-implant Defects Comparing Submerged Versus Non-submerged Healing
A study testing Submerged healing and Non-submerged healing in people with Peri-Implantitis, run by Ana Molina Villar at 1 site in Spain.
Trial summary
Objective: the objective of the present randomized clinical trial is to compare changes in radiographic peri-implant bone defect fill after regeneration of peri-implant intrabony defects with a submerged versus a non-submerged protocol. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Submerged healing and Non-submerged healing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2019to May 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
- Patients diagnosed of peri-implantitis requiring surgical therapy
- The periapical radiographic study demonstrates an intra-bony component greater than 3 mm at the affected implant
- There is at least 2 mm of keratinized mucosa around the affected implant
- Intrasurgically, peri-implant defects must be type Ia, Ib, Ic and Ie (according to Schwarz et al. 2007)
- Affected implants must be two-piece implants to allow for the submerged protocol
- Affected implant supported restorations must be screw-retained or cemented, and should allow for prostheses removal
Who cannot join
- Patients with untreated periodontitis
- Medical conditions requiring prolonged use of steroids and/or medications that can interfere with bone metabolism
- Metabolic disorders such as osteoporosis
- History of uncontrolled endocrine disorders
- History of leukocyte dysfunction and deficiencies
- History of immunodeficiency syndromes
Show all 12Show fewer
- History of neoplastic disease requiring the use of radiation of chemotherapy
- History of renal failure
- Physical handicaps that would interfere with the ability to perform adequate oral hygiene
- Alcoholism or drug abuse
- Smokers of more than 10 cigarettes per day, cigar equivalents or tobacco chewers
- Any other condition or circumstance that, in the opinion of the investigator, would prevent completion of study participation or interfere with the analysis of the study results, such as history of non-compliance or unreliability
Trial locations and contacts
1 site in 1 country.
Spain1 site
Dental School, University Complutense of Madrid
Madrid, 28040
Ana Molina, MSc
About this study
Official title: Guided Bone Regeneration of Peri-implant Defects Comparing Submerged Versus Non-submerged Healing: a Randomized Controlled Clinical Trial
Objective: the objective of the present randomized clinical trial is to compare changes in radiographic peri-implant bone defect fill after regeneration of peri-implant intrabony defects with a submerged versus a non-submerged protocol.
Material and Methods: this project is a randomized controlled clinical trial, double blind, with a parallel groups design. Thirty-six patients presenting with peri-implantitis subsidiary of regenerative treatment will be recruited. After subjects have been given informed consent, they will be randomized to test or control group. All patients will undergo a session of non-surgical peri-implantitis therapy consisting on prostheses removal and implant debridement with ultrasounds, curettes and air-abrasive under local anaesthesia. Patients in test group will have their prostheses removed and the mucosa surrounding the affected implants will be let heal covering the implants, while patients in control group will have their prostheses installed again after the non-surgical therapy. Six to eight weeks later, all subjects will undergo regenerative treatment with the use of a bone substitute, a collagen membrane and fixation pins, and in control group tissues will heal following the non-submerged protocol, meanwhile subjects in test group will undergo submerged healing. Six months later, subjects in test group will have their prostheses reconnected to the regenerated implants. All patients will undergo periodontal and peri-implant maintenance therapy every three months during follow-up. Radiographic assessment of vertical bone level changes (primary outcome), clinical status of peri-implant tissues, changes in soft tissues margin, patient related outcomes and adverse events will be assessed at 3, 6 and 12 months after peri-implantitis regenerative surgery.
- Conditions
- Peri-Implantitis
- Being tested
- Submerged healing, Non-submerged healing
- Keywords
- Peri-Implantitis, Peri-Implant Diseases, Bone Regeneration, Submerged Healing, Non-Submerged Healing, Dental Implants
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Submerged healingProcedure or surgery
Bone regeneration of peri-implantitis defects using a bone xenograft and a resorbable collagen membrane, with flap suturing using a submerged healing protocol
Non-submerged healingProcedure or surgery
Bone regeneration of peri-implantitis defects using a bone xenograft and a resorbable collagen membrane, with flap suturing using a non-submerged healing protocol
| Study group | Role | What they receive |
|---|---|---|
| Submerged healing | Experimental | Bone regeneration of peri-implantitis defects following a submerged healing Receives: Procedure: Submerged healing |
| Non-submerged healing | Active comparator | Bone regeneration of peri-implantitis defects following a non-submerged healing Receives: Procedure: Non-submerged healing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in radiographic bone fill
Changes in radiographic bone fill measured from the implant shoulder to the first bone to implant contact with ImageJ software, in parallelized periapical x-rays with individual silicone bite blocks
Measured: Baseline, 3 months, 6 months and 12 months post-surgery
Secondary outcomes (8)
Changes in pocket probing depth
Depth of the peri-implant sulcus/pocket measured in millimeters with a 15-UNC (University of North Carolina) periodontal probe, at six sites per implant without the crown
Measured: At baseline, after non-surgical therapy, 6 months and 12 months post-surgery
Changes in bone probing depth
Distance from the mucosal margin to the peri-implant bone measured in millimeters with a 15-UNC (University of North Carolina) periodontal probe under local anesthesia, at six sites per implant without the crown
Measured: At baseline, after non-surgical therapy and 12 months post-surgery
Changes in modified plaque index
Presence or absence of plaque assessed at six sites per tooth/implant in the whole mouth, excluding third molars
Measured: At baseline, after non-surgical therapy, 6 months and 12 months post-surgery
Changes in full mouth bleeding scores
Presence or absence of bleeding after probing with a 15-UNC (University of North Carolina) periodontal probe, assessed at six sites per tooth/implant in the whole mouth, excluding third molars. The presence of bleeding in each site will be scored 1, and the absence of bleeding will be scored 0. Full mouth bleeding score will be expressed in percentage and calculated as follows: number of sites bleeding / number of sites explored ^ 100
Measured: At baseline, after non-surgical therapy, 6 months and 12 months post-surgery
Soft tissue healing scores
Extent of soft tissue healing after surgery following Landry et al. Healing Index (1988):
- Healing index 1 - Very Poor
- Healing index 2 - Poor
- Healing index 3 - Good
- Healing index 4 - Very good
- Healing index 5 - Excellent
Measured: 1 week, 2 weeks and 4 weeks post-surgery
Pain assessment
Participants´ subjective pain assessed using a Visual Analogue Scale (VAS) with ratings from 0-10, whereof 0 = no pain and 10 = very intense.
Measured: 1 week, 2 weeks and 4 weeks post-surgery
Oral Health Impact Profile (OHIP-14)
Self-reported dysfunction, discomfort and disability attributed to the participants´ oral condition
Measured: Baseline, 3 months, 6 months and 12 months post-surgery
Adverse events´ occurrence
Occurrence of any untoward, undesired or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a subject participant in the clinical investigation. The event does not nee to be casually related to the cliinical investigation
Measured: Up to 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study startApr 2019 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ana Molina Villar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ana Molina Villar, Universidad Complutense de Madrid
- Investigators
- Mariano Sanz, MD DDS DrMed, Principal investigator, University Complutense of Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900741
- Sponsor's protocol ID
- 18/575-R_X
- Status last verified
- Apr 2019
- First submitted
- 1 Apr 2019
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Bone Regeneration of Peri-implant Defects Comparing Submerged Versus Non-submerged Healing: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03900741
- Acronym / sponsor ID
- 18/575-R_X
- Conditions
- Peri-Implantitis
- Keywords
- Peri-Implantitis, Peri-Implant Diseases, Bone Regeneration, Submerged Healing, Non-Submerged Healing, Dental Implants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Ana Molina VillarUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 3 Apr 2019 (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.
Objective: the objective of the present randomized clinical trial is to compare changes in radiographic peri-implant bone defect fill after regeneration of peri-implant intrabony defects with a submerged versus a non-submerged protocol.
Material and Methods: this project is a randomized controlled clinical trial, double blind, with a parallel groups design. Thirty-six patients presenting with peri-implantitis subsidiary of regenerative treatment will be recruited. After subjects have been given informed consent, they will be randomized to test or control group. All patients will undergo a session of non-surgical peri-implantitis therapy consisting on prostheses removal and implant debridement with ultrasounds, curettes and air-abrasive under local anaesthesia. Patients in test group will have their prostheses removed and the mucosa surrounding the affected implants will be let heal covering the implants, while patients in control group will have their prostheses installed again after the non-surgical therapy. Six to eight weeks later, all subjects will undergo regenerative treatment with the use of a bone substitute, a collagen membrane and fixation pins, and in control group tissues will heal following the non-submerged protocol, meanwhile subjects in test group will undergo submerged healing. Six months later, subjects in test group will have their prostheses reconnected to the regenerated implants. All patients will undergo periodontal and peri-implant maintenance therapy every three months during follow-up. Radiographic assessment of vertical bone level changes (primary outcome), clinical status of peri-implant tissues, changes in soft tissues margin, patient related outcomes and adverse events will be assessed at 3, 6 and 12 months after peri-implantitis regenerative surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Submerged healing | Experimental | Procedure: Submerged healingBone regeneration of peri-implantitis defects following a submerged healing |
| Non-submerged healing | Active comparator | Procedure: Non-submerged healingBone regeneration of peri-implantitis defects following a non-submerged healing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients diagnosed of peri-implantitis requiring surgical therapy
- The periapical radiographic study demonstrates an intra-bony component greater than 3 mm at the affected implant
- There is at least 2 mm of keratinized mucosa around the affected implant
- Intrasurgically, peri-implant defects must be type Ia, Ib, Ic and Ie (according to Schwarz et al. 2007)
- Affected implants must be two-piece implants to allow for the submerged protocol
Key exclusion criteria (12 listed)
- Patients with untreated periodontitis
- Medical conditions requiring prolonged use of steroids and/or medications that can interfere with bone metabolism
- Metabolic disorders such as osteoporosis
- History of uncontrolled endocrine disorders
- History of leukocyte dysfunction and deficiencies
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 |
|---|---|---|
| Submerged healingBone regeneration of peri-implantitis defects using a bone xenograft and a resorbable collagen membrane, with flap suturing using a submerged healing protocol | Procedure or surgery | Submerged healing |
| Non-submerged healingBone regeneration of peri-implantitis defects using a bone xenograft and a resorbable collagen membrane, with flap suturing using a non-submerged healing protocol | Procedure or surgery | Non-submerged healing |
Primary outcome
Changes in radiographic bone fill
Time frame: Baseline, 3 months, 6 months and 12 months post-surgery
Changes in radiographic bone fill measured from the implant shoulder to the first bone to implant contact with ImageJ software, in parallelized periapical x-rays with individual silicone bite blocks
8 secondary outcomes
Changes in pocket probing depth
Time frame: At baseline, after non-surgical therapy, 6 months and 12 months post-surgery
Changes in bone probing depth
Time frame: At baseline, after non-surgical therapy and 12 months post-surgery
Changes in modified plaque index
Time frame: At baseline, after non-surgical therapy, 6 months and 12 months post-surgery
Changes in full mouth bleeding scores
Time frame: At baseline, after non-surgical therapy, 6 months and 12 months post-surgery
Soft tissue healing scores
Time frame: 1 week, 2 weeks and 4 weeks post-surgery
Pain assessment
Time frame: 1 week, 2 weeks and 4 weeks post-surgery
Oral Health Impact Profile (OHIP-14)
Time frame: Baseline, 3 months, 6 months and 12 months post-surgery
Adverse events´ occurrence
Time frame: Up to 12 months post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- 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, MD DDS DrMed principal investigator
University Complutense of 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 Submerged healing and Non-submerged healing in people with Peri-Implantitis, run by Ana Molina Villar 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 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: status not confirmed, as of the sponsor's last update on 4 Apr 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 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 Ana Molina, MSc (0034647486381, ar.molina@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in radiographic bone fill (time frame: Baseline, 3 months, 6 months and 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.