Peri-ImplantitisPhase 4NCT03551145
Patient Perception and Clinical Efficacy of a Collagen Matrix for the Treatment of Peri-implantitis
A Phase 4 study testing Acellular collagen matrix and Autogenous free gingival graft in people with Peri-Implantitis, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
This is a multi-centre, randomized clinical trial which evaluates the efficiency of the collagen xenograft (Muco-Graft®) in comparison to the autologous connective tissue graft for the augmentation of keratinized mucosa and gaining hygienic access to the implants diagnosed with peri-implantitis. 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?
- Acellular collagen matrix and Autogenous free gingival graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2017to 1 Mar 2020
- Phase
- Phase 4
- 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
- Informed consent after the detailed information on the study.
- Adults aged at least 18 years old.
- Candidates for receiving augmentation of the peri-implant keratinized mucosa.
- Presence of the implant diagnosed with peri-implantitis (radiographic bone loss > 2 mm, with a probing depth > 5 mm, bleeding and/or suppuration (Lang et al., 2011)).
- Absent or insufficient keratinized peri-implant mucosa (<2 mm).
Who cannot join
- General contraindications for the dental/surgical treatment;
- Inflammatory or autoimmune disease of the oral cavity;
- Implant with radiographic intraosseous defects more than 3 mm;
- Smokers > 10 cig/day;
- Allergy to collagen or analgesics/anti-inflammatory non-steroid drugs;
- History of cancer in various parts of the body which required radiotherapy or chemotherapy during the last 5 years;
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- Radiotherapy of the head or neck in the last 5 years;
- Actual medication with immunosuppressors, bisphosphonates or high doses of corticosteroids;
- Pregnant or lactating women;
- Women in fertile age, who do not use effective methods of contraception;
- Participants of other studies of biomedical investigation during the last 24 weeks before initiation of the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Univesity Complutense, Madrid
Madrid, 28040
Elena Figuero, Doctor, 00913942018, elfiguer@ucm.es
Mariano Sanz
About this study
Official title: Patient Perception and Clinical Efficacy of Geistlich Mucograft® vs. Autologous Connective Tissue Graft for the Treatment of Peri-implantitis: Multi-centre Randomized Clinical Trial
This is a multi-centre, randomized clinical trial which evaluates the efficiency of the collagen xenograft (Muco-Graft®) in comparison to the autologous connective tissue graft for the augmentation of keratinized mucosa and gaining hygienic access to the implants diagnosed with peri-implantitis.
Read the detailed description
Nowadays, there is not enough evidence that evaluates the patient's perception of utilizing the soft tissue substitutes in comparison to the autologous connective tissue graft for the augmentation of the keratinized mucosa and gain of hygienic access to the implants with infectious pathology and with minimum or absent keratinized mucosa.
Therefore, the aim of the study is to evaluate the change of clinical parameters of peri-implant health and the patient perception of the procedure for augmentation of the keratinized tissues around dental implants with peri-implantitis.
The hypothesis is that collagen matrix of porcine origin is associated with lower patient morbidity, in comparison with autologous connective-tissue graft, when used for the augmentation of the keratinized tissues around endosseous dental implants with infectious pathology and with minimum or absent KT mucosa.
A sample 48 patients will be recruited basing upon the diagnosis of peri-implantitis and absent or insufficient peri- implant mucosa. 1 month after the non-surgical treatment, surgical procedure will be performed.
Peri-implant clinical and radiographic parameters, as well as patient perception of the therapy provided, will be evaluated before and at various stages (up to 52 weeks) after the surgical intervention. Also, change of vestibulum depth will be analyzed, as well as the time spent for the procedure measured.
- Conditions
- Peri-Implantitis
- Being tested
- Acellular collagen matrix, Autogenous free gingival graft
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular collagen matrixOther
3D collagen matrix consists of the collagen porcine type I and III
Autogenous free gingival graftOther
Autogenous graft harvested from the posterior palate
| Study group | Role | What they receive |
|---|---|---|
| Acellular collagen matrix | Experimental | In a test group, partial thickness-flap will be elevation will be performed, in order to create the vascular recipient bed for the randomized graft. Implant surface will be treated with ultrasound device, glycine powder and implantoplasty in case of the exposure of the rough surface. Acellular collagen matrix will be adapted and suture to the vascular bed. Receives: Other: Acellular collagen matrix |
| Autogenous free gingival graft | Active comparator | In a control group, partial thickness-flap will be elevation will be performed, in order to create the vascular recipient bed for the randomized graft. Implant surface will be treated with ultrasound device, glycine powder and implantoplasty in case of the exposure of the rough surface. Free gingival graft will be harvested from the zone of the posterior palate, and then adapted and sutured to the vascular bed. Receives: Other: Autogenous free gingival graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in width of keratinized peri-implant mucosa
Measured by periodontal probe (UNC-15), as mm of keratinized mucosa in the midbuccal portion of the implant of interest
Measured: Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks
Secondary outcomes (6)
Bleeding on probing
Measured as presence or absence (binary value) of bleeding 10 seconds after probing with the periodontal probe in 6 point around each implant
Measured: Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks
Probing depth
Measured by periodontal probe (UNC-15) in millimeters in 6 points around each implant, and defined as a distance from the mucosal margin to the bottom of the peri-implant pocket
Measured: Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks
Recession
Measured by periodontal probe (UNC-15) in millimeters in 6 points around each implant, and defined as a distance from the implant platform to the mucosal margin
Measured: Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks
General satisfaction by the treatment
Measured by a questionnaire, using the visual analogue scale, in values from 0 to 100
Measured: 0, 1, 2, 4, 12, 26 and 52 weeks
Duration of surgery
Measured by the electronic timer in minutes, starting from the moment of first incision and ending with a last suture
Measured: after completion of surgical intervention
Vestibulum depth
Measured in mm by a periodontal probe, as a distance from the mucosal margin to the point of greatest concavity of the mucobuccal fold
Measured: Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start1 Feb 2017
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Mar 2020 (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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-centre randomized clinical trial (2 centres) with the duration of 102 weeks for the evaluation of efficiency on the new collagen xenograft (Muco-Graft®) in comparison to the autologous connective tissue graft for the augmentation of keratinized mucosa and gaining hygienic access to the implants diagnosed with peri-implantitis
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- PerioCentrum Research
- Responsible party
- Principal investigator, Prof. Elena Figuero, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551145
- Sponsor's protocol ID
- 16/502-P
- Status last verified
- May 2018
- First submitted
- 9 May 2018
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Perception and Clinical Efficacy of Geistlich Mucograft® vs. Autologous Connective Tissue Graft for the Treatment of Peri-implantitis: Multi-centre Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03551145
- Acronym / sponsor ID
- 16/502-P
- Conditions
- Peri-Implantitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- PerioCentrum Research
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 11 Jun 2018 (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 is a multi-centre, randomized clinical trial which evaluates the efficiency of the collagen xenograft (Muco-Graft®) in comparison to the autologous connective tissue graft for the augmentation of keratinized mucosa and gaining hygienic access to the implants diagnosed with peri-implantitis.
Detailed description
Nowadays, there is not enough evidence that evaluates the patient's perception of utilizing the soft tissue substitutes in comparison to the autologous connective tissue graft for the augmentation of the keratinized mucosa and gain of hygienic access to the implants with infectious pathology and with minimum or absent keratinized mucosa.
Therefore, the aim of the study is to evaluate the change of clinical parameters of peri-implant health and the patient perception of the procedure for augmentation of the keratinized tissues around dental implants with peri-implantitis.
The hypothesis is that collagen matrix of porcine origin is associated with lower patient morbidity, in comparison with autologous connective-tissue graft, when used for the augmentation of the keratinized tissues around endosseous dental implants with infectious pathology and with minimum or absent KT mucosa.
A sample 48 patients will be recruited basing upon the diagnosis of peri-implantitis and absent or insufficient peri- implant mucosa. 1 month after the non-surgical treatment, surgical procedure will be performed.
Peri-implant clinical and radiographic parameters, as well as patient perception of the therapy provided, will be evaluated before and at various stages (up to 52 weeks) after the surgical intervention. Also, change of vestibulum depth will be analyzed, as well as the time spent for the procedure measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-centre randomized clinical trial (2 centres) with the duration of 102 weeks for the evaluation of efficiency on the new collagen xenograft (Muco-Graft®) in comparison to the autologous connective tissue graft for the augmentation of keratinized mucosa and gaining hygienic access to the implants diagnosed with peri-implantitis
| Arm | Type | Receives |
|---|---|---|
| Acellular collagen matrix | Experimental | Other: Acellular collagen matrixIn a test group, partial thickness-flap will be elevation will be performed, in order to create the vascular recipient bed for the randomized graft. Implant surface will be treated with ultrasound device, glycine powder and implantoplasty in case of the exposure of the rough surface. Acellular collagen matrix will be adapted and suture to the vascular bed. |
| Autogenous free gingival graft | Active comparator | Other: Autogenous free gingival graftIn a control group, partial thickness-flap will be elevation will be performed, in order to create the vascular recipient bed for the randomized graft. Implant surface will be treated with ultrasound device, glycine powder and implantoplasty in case of the exposure of the rough surface. Free gingival graft will be harvested from the zone of the posterior palate, and then adapted and sutured to the vascular bed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent after the detailed information on the study.
- Adults aged at least 18 years old.
- Candidates for receiving augmentation of the peri-implant keratinized mucosa.
- Presence of the implant diagnosed with peri-implantitis (radiographic bone loss > 2 mm, with a probing depth > 5 mm, bleeding and/or suppuration (Lang et al., 2011)).
- Absent or insufficient keratinized peri-implant mucosa (<2 mm).
Key exclusion criteria (11 listed)
- General contraindications for the dental/surgical treatment;
- Inflammatory or autoimmune disease of the oral cavity;
- Implant with radiographic intraosseous defects more than 3 mm;
- Smokers > 10 cig/day;
- Allergy to collagen or analgesics/anti-inflammatory non-steroid drugs;
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 |
|---|---|---|
| Acellular collagen matrix3D collagen matrix consists of the collagen porcine type I and III | Other | Acellular collagen matrix |
| Autogenous free gingival graftAutogenous graft harvested from the posterior palate | Other | Autogenous free gingival graft |
Primary outcome
Change in width of keratinized peri-implant mucosa
Time frame: Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks
Measured by periodontal probe (UNC-15), as mm of keratinized mucosa in the midbuccal portion of the implant of interest
6 secondary outcomes
Bleeding on probing
Time frame: Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks
Probing depth
Time frame: Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks
Recession
Time frame: Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks
General satisfaction by the treatment
Time frame: 0, 1, 2, 4, 12, 26 and 52 weeks
Duration of surgery
Time frame: after completion of surgical intervention
Vestibulum depth
Time frame: Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acellular collagen matrix and Autogenous free gingival graft in people with Peri-Implantitis, 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 11 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 11 Jun 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Myroslav Solonko, DDS (34684354549, msolonko@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in width of keratinized peri-implant mucosa (time frame: Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks). 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 11 Jun 2018.