Peri-ImplantitisNCT05171582
Peri-implantitis Surgical Regenerative Therapy Using Bovine Bone Substitute With Hyaluronic Acid
A study testing Surgery 1 (Test group) in people with Peri-Implantitis, run by Botiss Medical AG at 1 site in Serbia.
Trial summary
The study aimed to assess 6- and 12-months evaluation of clinical, microbiological, and radiography outcomes after performing peri-implantitis regenerative surgical therapy with the bovine bone substitute with or without hyaluronic acid. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Surgery 1 (Test group)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSerbia
- Study dates
- 15 Apr 2021to 15 Nov 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peri-implantitis with:
- Presence of peri-implant pocket > 5mm,
- Bleeding on probing (BOP),
- Radiographic evidence of bone loss > 3mm, or one or two-third bone loss
- Implant in function for more than one year (prosthetic rehabilitation for more than six months)
- Good level of oral hygiene (plaque index <1)
Show all 9Show fewer
- No periodontal or peri-implant treatment three months prior to the study
- No use antibiotics in the last three months
- No anti-inflammatory drugs were used in the previous two months
Who cannot join
- Buccally implant placement, implant mobility, two-third of bone loss, patient with systemic conditions (diabetes mellitus, leukemia), patient on radiation therapy, drug and alcohol abuse, pregnant and breastfeeding, women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Periimplantitis Surgical Regenerative Therapy Using Bovine Bone Substitute With Hyaluronic Acid: Randomized Controlled Clinical Trials
The study aimed to assess 6- and 12-months evaluation of clinical, microbiological, and radiography outcomes after performing peri-implantitis regenerative surgical therapy with the bovine bone substitute with or without hyaluronic acid.
Materials and Methods: The study could be designed as randomized control clinical trial. Patients with a minimum of one or more early, moderate and advanced stages of the peri-implant lesion will be included in the study. After meeting inclusion criteria, during a regenerative surgical procedure, after mucoperiosteal flap elevation and implant surface decontamination, all patients will be randomly divided into two groups: test group in which bovine bone substitute with hyaluronic acid (HA) (Cerabone plus, Botiss, Germany) will be applied for the filling peri-implant bone defects while in the control group peri-implant bone defects will be filled with bovine bone substitute (Cerabone, Botiss, Germany). Bone grafts will be covered in both groups with collagen dermal matrix (Mucoderm, Botiss, Germany). Clinical, radiograph and microbiological outcomes will be followed at 6 and 12 months after the surgical procedure. ISQ implant stability will be measured before, during a surgical procedure, and 7, 15, 30 days, 3, 6 and 12 months after a surgical procedure.
Read the detailed description
Treatment procedure
After the crown was removed immediately, ISQ implant stability and clinical parameters will be measured, and the sample for microbiological analyses will be taken.
Subsequently, patients with a minimum of one or more diagnosed periimplantitis will undergo non-surgical periimplantitis therapy in order to reduce inflammation. The patient will be instructed on adequate oral hygiene. Antibiotics and mouths wash will not be prescribed in this phase.
Surgical procedure
Two weeks after the non-surgical procedure, surgical regenerative therapy will be performed by experienced operators. After local anaesthesia, a full-mucoperiosteal flap will be evaluated. ISQ implant stability will be measured before implant debridement. After granulation tissue is removed by using titanium or graphite curettes, ISQ implant stability will be measured, and implant surface decontamination will be performed, respectively. Implant surface decontamination will be performed by titanium brushes and photodynamic therapy. After implant surface decontamination, bone defect and soft tissue thickness will be measured intra-operatively using a periodontal probe. In the cases where there is additional supracrestal bone lost the implantoplasty will be performed. Thereafter, the bone defects around treated implants will be full-filled either with bovine bone substitute with or without HA (Cerabone plus or Cerabone) and Mucoderm will be inserted. Microderm (Botiss, Germany) will be fixed with 5.0 resorbable sutures. The flap will be coronally positioned and sutured with 5.0 non-resorbable sutures, respectively.
ISQ implant stability will be measured after the flap was sutured. The temporary crown will be inserted, respectively.
Patients will be prescribed antibiotics (Amoxicillin 500 mg, three times per day, in seven days), and 0,12% chlorhexidine solution for 14 days. Sutures will be removed 7 days after surgery.
Prosthetic outcomes
Every patient with periimplantitis will be scanned with an intraoral scanner in order to define premature contacts or interferent contacts in excentre movements of implants. The scan will be taken before any therapy, six, and 12 months after the surgical therapy.
In the first visit, where it is possible, the crown will be removed, and the impression for the temporary crown will be taken, depending on group distribution. A temporary crown will be fixed immediately after the surgical procedure, while the new permanent crown will be made a minimum of three months after surgery. Crowns will be screw-retained. Dental implant emergent profile will be evaluated at 6 and 12 months after prosthetic rehabilitation.
Gained results will be statistically analyzed using SPSS softer.
- Conditions
- Peri-Implantitis
- Being tested
- Surgery 1 (Test group), Surgery 2 (Control group)
- Keywords
- regenerative surgery, periimplantitis, photodynamic therapy
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery 1 (Test group)Procedure or surgery
After local anaesthesia, a full-mucoperiosteal flap will be evaluated. After granulation tissue is removed by using titanium or graphite curettes and implant surface decontamination will be performed using photodynamic therapy. Thereafter, the peri-implant bone defects in the test group will be full-filled either with bovine bone substitute with hyaluronic acid (Cerabone plus). Collagen dermal matrix (Mucoderm) will be inserted instead of a collagen membrane. Mucoderm will be fixed with 5.0 resorbable sutures. The flap will be coronally positioned and sutured with 5.0 non-resorbable sutures, respectively.
Surgery 2 (Control group)Procedure or surgery
After local anaesthesia, a full-mucoperiosteal flap will be evaluated. After granulation tissue is removed by using titanium or graphite curettes and implant surface decontamination will be performed using photodynamic therapy. Thereafter, the peri-implant bone defects in the control group will be full-filled either with bovine bone substitute (Cerabone). Collagen dermal matrix (Mucoderm) will be inserted instead of a collagen membrane. Mucoderm will be fixed with 5.0 resorbable sutures. The flap will be coronally positioned and sutured with 5.0 non-resorbable sutures, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Surgery 1 (Test group) | Active comparator | In the test group (T), bone defects will be full-filled with bovine bone substitute with HA (Cerabone plus, Botiss, Germany) Receives: Procedure: Surgery 1 (Test group) |
| Surgery 2 (Control group) | Active comparator | In the control group (C), bone defects will be full-filled with xenograft bovine bone substitute without HA (Cerabone, Botiss, Germany). Receives: Procedure: Surgery 2 (Control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of clinical attachment level (CAL)
CAL, measured in millimetres as the distance from implant shoulder to the bottom of peri-implant pocket at six points.
Measured: Change from baseline CAL at 12 months
Change of Peri-implant probing depths (PPD)
PPD, measured in millimetres as the distance from mucosal margin to bottom of periodontal pocket.
Measured: Change from baseline PPD at 12 months
Secondary outcomes (3)
Change of Keratinized tissue width (KTW)
KTW, measured at the middle of the inserted implant in the millimetres as the distance between MM of the implant to a mucogingival junction (MGJ).
Measured: Change from baseline KTW at 12 months
Change of gingival thickness (GT)
GT, measured at the mid-buccal aspect of treated implants on the long axis, 3 mm apically from perimucosal tissue margin.
Measured: Change from baseline GT at 12 months
Healing index (HI) score
Assess of the wound healing based on redness, granulation tissue presence, bleeding, suppuration, and epithelialization
Measured: Changes of the wound healing within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start15 Apr 2021
- Primary completion15 May 2023 (estimated)
- Study completion15 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Botiss Medical AG
- Sponsor type
- University, hospital or other
- Collaborators
- Military Medical Academy, Bulgaria
- Responsible party
- Principal investigator, Dragana Rakasevic, Botiss Medical AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171582
- Sponsor's protocol ID
- 36/25
- Status last verified
- Dec 2021
- First submitted
- 12 Dec 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will be published in International Journal
Publications
Albrektsson T, Canullo L, Cochran D, De Bruyn H. "Peri-Implantitis": A Complication of a Foreign Body or a Man-Made "Disease". Facts and Fiction. Clin Implant Dent Relat Res. 2016 Aug;18(4):840-9. doi: 10.1111/cid.12427. Epub 2016 May 30.
PubMed 27238274Mombelli A. Etiology, diagnosis, and treatment considerations in peri-implantitis. Curr Opin Periodontol. 1997;4:127-36.
PubMed 9655032Schwarz F, Jepsen S, Herten M, Sager M, Rothamel D, Becker J. Influence of different treatment approaches on non-submerged and submerged healing of ligature induced peri-implantitis lesions: an experimental study in dogs. J Clin Periodontol. 2006 Aug;33(8):584-95. doi: 10.1111/j.1600-051X.2006.00956.x.
PubMed 16899102Schwarz F, Sahm N, Bieling K, Becker J. Surgical regenerative treatment of peri-implantitis lesions using a nanocrystalline hydroxyapatite or a natural bone mineral in combination with a collagen membrane: a four-year clinical follow-up report. J Clin Periodontol. 2009 Sep;36(9):807-14. doi: 10.1111/j.1600-051X.2009.01443.x. Epub 2009 Jul 21.
PubMed 19637997Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Periodontol. 2018 Jun;89 Suppl 1:S267-S290. doi: 10.1002/JPER.16-0350.
PubMed 29926957
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Periimplantitis Surgical Regenerative Therapy Using Bovine Bone Substitute With Hyaluronic Acid: Randomized Controlled Clinical Trials
- ClinicalTrials.gov ID
- NCT05171582
- Acronym / sponsor ID
- 36/25
- Conditions
- Peri-Implantitis
- Keywords
- regenerative surgery, periimplantitis, photodynamic therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Botiss Medical AGUniversity, hospital or other
- Collaborators
- Military Medical Academy, Bulgaria
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 15 Nov 2023 (estimated)
- First posted
- 29 Dec 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 study aimed to assess 6- and 12-months evaluation of clinical, microbiological, and radiography outcomes after performing peri-implantitis regenerative surgical therapy with the bovine bone substitute with or without hyaluronic acid.
Materials and Methods: The study could be designed as randomized control clinical trial. Patients with a minimum of one or more early, moderate and advanced stages of the peri-implant lesion will be included in the study. After meeting inclusion criteria, during a regenerative surgical procedure, after mucoperiosteal flap elevation and implant surface decontamination, all patients will be randomly divided into two groups: test group in which bovine bone substitute with hyaluronic acid (HA) (Cerabone plus, Botiss, Germany) will be applied for the filling peri-implant bone defects while in the control group peri-implant bone defects will be filled with bovine bone substitute (Cerabone, Botiss, Germany). Bone grafts will be covered in both groups with collagen dermal matrix (Mucoderm, Botiss, Germany). Clinical, radiograph and microbiological outcomes will be followed at 6 and 12 months after the surgical procedure. ISQ implant stability will be measured before, during a surgical procedure, and 7, 15, 30 days, 3, 6 and 12 months after a surgical procedure.
Detailed description
Treatment procedure
After the crown was removed immediately, ISQ implant stability and clinical parameters will be measured, and the sample for microbiological analyses will be taken.
Subsequently, patients with a minimum of one or more diagnosed periimplantitis will undergo non-surgical periimplantitis therapy in order to reduce inflammation. The patient will be instructed on adequate oral hygiene. Antibiotics and mouths wash will not be prescribed in this phase.
Surgical procedure
Two weeks after the non-surgical procedure, surgical regenerative therapy will be performed by experienced operators. After local anaesthesia, a full-mucoperiosteal flap will be evaluated. ISQ implant stability will be measured before implant debridement. After granulation tissue is removed by using titanium or graphite curettes, ISQ implant stability will be measured, and implant surface decontamination will be performed, respectively. Implant surface decontamination will be performed by titanium brushes and photodynamic therapy. After implant surface decontamination, bone defect and soft tissue thickness will be measured intra-operatively using a periodontal probe. In the cases where there is additional supracrestal bone lost the implantoplasty will be performed. Thereafter, the bone defects around treated implants will be full-filled either with bovine bone substitute with or without HA (Cerabone plus or Cerabone) and Mucoderm will be inserted. Microderm (Botiss, Germany) will be fixed with 5.0 resorbable sutures. The flap will be coronally positioned and sutured with 5.0 non-resorbable sutures, respectively.
ISQ implant stability will be measured after the flap was sutured. The temporary crown will be inserted, respectively.
Patients will be prescribed antibiotics (Amoxicillin 500 mg, three times per day, in seven days), and 0,12% chlorhexidine solution for 14 days. Sutures will be removed 7 days after surgery.
Prosthetic outcomes
Every patient with periimplantitis will be scanned with an intraoral scanner in order to define premature contacts or interferent contacts in excentre movements of implants. The scan will be taken before any therapy, six, and 12 months after the surgical therapy.
In the first visit, where it is possible, the crown will be removed, and the impression for the temporary crown will be taken, depending on group distribution. A temporary crown will be fixed immediately after the surgical procedure, while the new permanent crown will be made a minimum of three months after surgery. Crowns will be screw-retained. Dental implant emergent profile will be evaluated at 6 and 12 months after prosthetic rehabilitation.
Gained results will be statistically analyzed using SPSS softer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Surgery 1 (Test group) | Active comparator | Procedure: Surgery 1 (Test group)In the test group (T), bone defects will be full-filled with bovine bone substitute with HA (Cerabone plus, Botiss, Germany) |
| Surgery 2 (Control group) | Active comparator | Procedure: Surgery 2 (Control group)In the control group (C), bone defects will be full-filled with xenograft bovine bone substitute without HA (Cerabone, Botiss, Germany). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Presence of peri-implant pocket > 5mm,
- Bleeding on probing (BOP),
- Radiographic evidence of bone loss > 3mm, or one or two-third bone loss
- Implant in function for more than one year (prosthetic rehabilitation for more than six months)
- Good level of oral hygiene (plaque index <1)
Key exclusion criteria (1 listed)
- Buccally implant placement, implant mobility, two-third of bone loss, patient with systemic conditions (diabetes mellitus, leukemia), patient on radiation therapy, drug and alcohol abuse, pregnant and breastfeeding, women
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 |
|---|---|---|
| Surgery 1 (Test group)After local anaesthesia, a full-mucoperiosteal flap will be evaluated. After granulation tissue is removed by using titanium or graphite curettes and implant surface decontamination will be performed using photodynamic therapy. Thereafter, the peri-implant bone defects in the test group will be full-filled either with bovine bone substitute with hyaluronic acid (Cerabone plus). Collagen dermal matrix (Mucoderm) will be inserted instead of a collagen membrane. Mucoderm will be fixed with 5.0 resorbable sutures. The flap will be coronally positioned and sutured with 5.0 non-resorbable sutures, respectively. | Procedure or surgery | Surgery 1 (Test group) |
| Surgery 2 (Control group)After local anaesthesia, a full-mucoperiosteal flap will be evaluated. After granulation tissue is removed by using titanium or graphite curettes and implant surface decontamination will be performed using photodynamic therapy. Thereafter, the peri-implant bone defects in the control group will be full-filled either with bovine bone substitute (Cerabone). Collagen dermal matrix (Mucoderm) will be inserted instead of a collagen membrane. Mucoderm will be fixed with 5.0 resorbable sutures. The flap will be coronally positioned and sutured with 5.0 non-resorbable sutures, respectively. | Procedure or surgery | Surgery 2 (Control group) |
Primary outcome
Change of clinical attachment level (CAL)
Time frame: Change from baseline CAL at 12 months
CAL, measured in millimetres as the distance from implant shoulder to the bottom of peri-implant pocket at six points.
Change of Peri-implant probing depths (PPD)
Time frame: Change from baseline PPD at 12 months
PPD, measured in millimetres as the distance from mucosal margin to bottom of periodontal pocket.
3 secondary outcomes
Change of Keratinized tissue width (KTW)
Time frame: Change from baseline KTW at 12 months
Change of gingival thickness (GT)
Time frame: Change from baseline GT at 12 months
Healing index (HI) score
Time frame: Changes of the wound healing within 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Background: PubMed 27238274Albrektsson T, Canullo L, Cochran D, De Bruyn H. "Peri-Implantitis": A Complication of a Foreign Body or a Man-Made "Disease". Facts and Fiction. Clin Implant Dent Relat Res. 2016 Aug;18(4):840-9. doi: 10.1111/cid.12427. Epub 2016 May 30.
- Background: PubMed 9655032Mombelli A. Etiology, diagnosis, and treatment considerations in peri-implantitis. Curr Opin Periodontol. 1997;4:127-36.
- Background: PubMed 16899102Schwarz F, Jepsen S, Herten M, Sager M, Rothamel D, Becker J. Influence of different treatment approaches on non-submerged and submerged healing of ligature induced peri-implantitis lesions: an experimental study in dogs. J Clin Periodontol. 2006 Aug;33(8):584-95. doi: 10.1111/j.1600-051X.2006.00956.x.
- Background: PubMed 19637997Schwarz F, Sahm N, Bieling K, Becker J. Surgical regenerative treatment of peri-implantitis lesions using a nanocrystalline hydroxyapatite or a natural bone mineral in combination with a collagen membrane: a four-year clinical follow-up report. J Clin Periodontol. 2009 Sep;36(9):807-14. doi: 10.1111/j.1600-051X.2009.01443.x. Epub 2009 Jul 21.
- Results publication: PubMed 29926957Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Periodontol. 2018 Jun;89 Suppl 1:S267-S290. doi: 10.1002/JPER.16-0350.
- Individual participant dataSharing planned: Yes. Will be published in International Journal
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery 1 (Test group) in people with Peri-Implantitis, run by Botiss Medical AG at 1 site in Serbia.
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 9 inclusion and 1 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 29 Dec 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 Serbia. 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?
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?
Change of clinical attachment level (CAL) (time frame: Change from baseline CAL at 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05171582, which also lists 5 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 29 Dec 2021.