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Peri-implantitis Surgical Regenerative Therapy Using Bovine Bone Substitute With Hyaluronic Acid

Primary Purpose

Peri-Implantitis

Status
Active
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Surgery 1 (Test group)
Surgery 2 (Control group)
Sponsored by
Botiss Medical AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-Implantitis focused on measuring regenerative surgery, periimplantitis, photodynamic therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Peri-implantitis with:

  1. Presence of peri-implant pocket > 5mm,
  2. Bleeding on probing (BOP),
  3. Radiographic evidence of bone loss > 3mm, or one or two-third bone loss
  4. Implant in function for more than one year (prosthetic rehabilitation for more than six months)
  5. Good level of oral hygiene (plaque index <1)
  6. No periodontal or peri-implant treatment three months prior to the study
  7. No use antibiotics in the last three months
  8. No anti-inflammatory drugs were used in the previous two months

Exclusion Criteria:

  • 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

Sites / Locations

  • School of Dental Medicine, University of Belgrade

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Surgery 1 (Test group)

Surgery 2 (Control group)

Arm Description

In the test group (T), bone defects will be full-filled with bovine bone substitute with HA (Cerabone plus, Botiss, Germany)

In the control group (C), bone defects will be full-filled with xenograft bovine bone substitute without HA (Cerabone, Botiss, Germany).

Outcomes

Primary Outcome Measures

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.
Change of Peri-implant probing depths (PPD)
PPD, measured in millimetres as the distance from mucosal margin to bottom of periodontal pocket.

Secondary Outcome Measures

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).
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.
Healing index (HI) score
Assess of the wound healing based on redness, granulation tissue presence, bleeding, suppuration, and epithelialization

Full Information

First Posted
December 12, 2021
Last Updated
December 26, 2021
Sponsor
Botiss Medical AG
Collaborators
Military Medical Academy
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1. Study Identification

Unique Protocol Identification Number
NCT05171582
Brief Title
Peri-implantitis Surgical Regenerative Therapy Using Bovine Bone Substitute With Hyaluronic Acid
Official Title
The Effect of Periimplantitis Surgical Regenerative Therapy Using Bovine Bone Substitute With Hyaluronic Acid: Randomized Controlled Clinical Trials
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Botiss Medical AG
Collaborators
Military Medical Academy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis
Keywords
regenerative surgery, periimplantitis, photodynamic therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Single Blind
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgery 1 (Test group)
Arm Type
Active Comparator
Arm Description
In the test group (T), bone defects will be full-filled with bovine bone substitute with HA (Cerabone plus, Botiss, Germany)
Arm Title
Surgery 2 (Control group)
Arm Type
Active Comparator
Arm Description
In the control group (C), bone defects will be full-filled with xenograft bovine bone substitute without HA (Cerabone, Botiss, Germany).
Intervention Type
Procedure
Intervention Name(s)
Surgery 1 (Test group)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Surgery 2 (Control group)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of clinical attachment level (CAL)
Description
CAL, measured in millimetres as the distance from implant shoulder to the bottom of peri-implant pocket at six points.
Time Frame
Change from baseline CAL at 12 months
Title
Change of Peri-implant probing depths (PPD)
Description
PPD, measured in millimetres as the distance from mucosal margin to bottom of periodontal pocket.
Time Frame
Change from baseline PPD at 12 months
Secondary Outcome Measure Information:
Title
Change of Keratinized tissue width (KTW)
Description
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).
Time Frame
Change from baseline KTW at 12 months
Title
Change of gingival thickness (GT)
Description
GT, measured at the mid-buccal aspect of treated implants on the long axis, 3 mm apically from perimucosal tissue margin.
Time Frame
Change from baseline GT at 12 months
Title
Healing index (HI) score
Description
Assess of the wound healing based on redness, granulation tissue presence, bleeding, suppuration, and epithelialization
Time Frame
Changes of the wound healing within 30 days
Other Pre-specified Outcome Measures:
Title
Radiography measurements of peri-implant defects
Description
Radiography measurements of peri-implant defects will be performed using CBCT and x-ray
Time Frame
Measured at baseline and 12 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
>18 years of age Competent to fully understand all information regarding the research protocol of the study and to sign a written consent for participation
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) 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 Exclusion Criteria: 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
Facility Information:
Facility Name
School of Dental Medicine, University of Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Will be published in International Journal
IPD Sharing Time Frame
from 2022. to 2024.
IPD Sharing Access Criteria
There are no access criteria
Citations:
PubMed Identifier
27238274
Citation
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.
Results Reference
background
PubMed Identifier
9655032
Citation
Mombelli A. Etiology, diagnosis, and treatment considerations in peri-implantitis. Curr Opin Periodontol. 1997;4:127-36.
Results Reference
background
PubMed Identifier
16899102
Citation
Schwarz 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.
Results Reference
background
PubMed Identifier
19637997
Citation
Schwarz 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 Reference
background
PubMed Identifier
29926957
Citation
Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Periodontol. 2018 Jun;89 Suppl 1:S267-S290. doi: 10.1002/JPER.16-0350.
Results Reference
result

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Peri-implantitis Surgical Regenerative Therapy Using Bovine Bone Substitute With Hyaluronic Acid

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