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

NCT05171582 | Unknown DMC

• 1 other identifier: 36/25
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-Implantitis

Keywords

regenerative surgery, periimplantitis, photodynamic therapy

Outcome Measures

Primary Outcomes (2)

• 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 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.

  Change from baseline PPD at 12 months

Secondary Outcomes (3)

• Change of Keratinized tissue width (KTW)

  Change from baseline KTW at 12 months

• Change of gingival thickness (GT)

  Change from baseline GT at 12 months

• Healing index (HI) score

  Changes of the wound healing within 30 days

Other Outcomes (1)

• Radiography measurements of peri-implant defects

  Measured at baseline and 12 months

Study Arms (2)

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)

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).

Procedure: Surgery 2 (Control group)

Interventions

Surgery 1 (Test group) PROCEDURE

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 1 (Test group)

Surgery 2 (Control group) PROCEDURE

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.

Surgery 2 (Control group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: 1. \>18 years of age 2. Competent to fully understand all information regarding the research protocol of the study and to sign a written consent for participation
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Botiss Medical AG: lead
• Military Medical Academy, Bulgaria: collaborator

Study Sites (1)

School of Dental Medicine, University of Belgrade

Belgrade, 11000, Serbia

Location

Related Publications (5)

• 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.

  PMID: 27238274 BACKGROUND

• Mombelli A. Etiology, diagnosis, and treatment considerations in peri-implantitis. Curr Opin Periodontol. 1997;4:127-36.

  PMID: 9655032 BACKGROUND

• 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.

  PMID: 16899102 BACKGROUND

• 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.

  PMID: 19637997 BACKGROUND

• 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.

  PMID: 29926957 RESULT

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Single Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Research Associate

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: December 29, 2021
• Study Start: April 15, 2021
• Primary Completion: May 15, 2023
• Study Completion: November 15, 2023
• Last Updated: December 29, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: from 2022. to 2024.
• Access Criteria: There are no access criteria

Locations

SE (1)