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

December 26, 2021 updated by: Dragana Rakasevic, Botiss Medical AG

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • School of dental medicine, University of Belgrade

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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)
Procedure: 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.
Active Comparator: 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).
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 from baseline CAL at 12 months
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.
Change from baseline PPD at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Keratinized tissue width (KTW)
Time Frame: Change from baseline KTW at 12 months
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 from baseline KTW at 12 months
Change of gingival thickness (GT)
Time Frame: Change from baseline GT at 12 months
GT, measured at the mid-buccal aspect of treated implants on the long axis, 3 mm apically from perimucosal tissue margin.
Change from baseline GT at 12 months
Healing index (HI) score
Time Frame: Changes of the wound healing within 30 days
Assess of the wound healing based on redness, granulation tissue presence, bleeding, suppuration, and epithelialization
Changes of the wound healing within 30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiography measurements of peri-implant defects
Time Frame: Measured at baseline and 12 months
Radiography measurements of peri-implant defects will be performed using CBCT and x-ray
Measured at baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Botiss Medical AG

Collaborators

Military Medical Academy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Anticipated)

May 15, 2023

Study Completion (Anticipated)

November 15, 2023

Study Registration Dates

First Submitted

December 12, 2021

First Submitted That Met QC Criteria

December 26, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Actual)

December 29, 2021

Last Update Submitted That Met QC Criteria

December 26, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

IPD Sharing Supporting Information Type

  • Study Protocol
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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