Surgical Treatment of Peri-implantitis Defects

NCT ID: NCT06614426

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2026-12-30

Brief Summary

The aim of this study is to evaluate the efficacy of implant surface decontamination using electrolysis cleaning system. And to evaluate the adjunctive use of L-PRF in promoting soft tissue healing and long-term stability of the peri-implant marginal bone in the surgical treatment of peri-implantitis.

Detailed Description

Research design

• Prospective, in which participants will be recruited and then followed up throughout a specified period of time.
• Randomized, parallel designed, concurrent controlled trial with participants randomly allocated to either control or test groups.
• Single-blinded as the outcome accessors will be blinded to the intervention.

Materials and Methods:

Patients attending Dubai Dental Hospital and requiring treatment of peri-implantitis will be invited to take part in this randomized controlled trial based on the following inclusion and exclusion criteria:

Inclusion criteria:

• Aged 18 or over.
• Require treatment of peri-implantitis (defined as the presence of bleeding and/or suppuration on gentle probing, probing depths of ≥ 6 mm, presence of bone loss beyond crestal bone level changes resulting from initial bone remodeling).
• Screw retained implant crown.
• Good compliance and commitment to attend follow-up review appointments.
• Willing to provide informed consent.

Exclusion criteria

• History of surgical therapy of peri-implantitis.
• Peri-implant defects indicated for regenerative procedure (i.e. contained bony defect).
• Cement retained implant crown.
• Systemic/local antibiotics during the previous 6 months.
• Bone metabolic disease and/or taking medications that affect bone metabolism.
• History of malignancy, radiotherapy or chemotherapy.
• Pregnant or lactating women.
• Smokers

The study will be conducted following the ethical standards of the Declaration of Helsinki in 1975, as revised in 2013 and the CONSORT statement will be used as a guideline in reporting this study.

Randomization, allocation concealment and blinding:

The participants will be randomly allocated to three equally sized groups using computer-generated numbers:

Control group (C): Conventional open flap debridement Test group 1 (T1): Open flap debridement using (GalvoSurge® - Straumann) Test group 2 (T2): Open flap debridement using (GalvoSurge® - Straumann) combined with L-PRF application

Conditions

Peri Implantitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group (C): Conventional open flap debridement

Conventional open flap debridement

Group Type: ACTIVE_COMPARATOR

Control group (C)

Intervention Type: PROCEDURE

Conventional open flap debridement

Test group 1 (T1): Open flap debridement using electrolysis decontamination

Open flap debridement using (GalvoSurge® - Straumann)

Group Type: EXPERIMENTAL

Test group 1 (T1)

Intervention Type: PROCEDURE

Test group 1 (T1): Open flap debridement using electrolysis decontamination

Test group 2 (T2): Open flap debridement using electrolysis decontamination combined with L-PRF

Open flap debridement using (GalvoSurge® - Straumann) combined with L-PRF application

Group Type: EXPERIMENTAL

Test group 2 (T2)

Intervention Type: PROCEDURE

Test group 2 (T2): Open flap debridement using electrolysis decontamination combined with L-PRF application

Interventions

Test group 1 (T1)

Test group 1 (T1): Open flap debridement using electrolysis decontamination

Intervention Type: PROCEDURE

Test group 2 (T2)

Test group 2 (T2): Open flap debridement using electrolysis decontamination combined with L-PRF application

Intervention Type: PROCEDURE

Control group (C)

Conventional open flap debridement

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Aged 18 or over.
• Require treatment of peri-implantitis (defined as the presence of bleeding and/or suppuration on gentle probing, probing depths of ≥ 6 mm, presence of bone loss beyond crestal bone level changes resulting from initial bone remodeling).
• Screw retained implant crown.
• Good compliance and commitment to attend follow-up review appointments.
• Willing to provide informed consent.

Exclusion Criteria

• History of surgical therapy of peri-implantitis.
• Peri-implant defects indicated for regenerative procedure (i.e. contained bony defect).
• Cement retained implant crown.
• Systemic/local antibiotics during the previous 6 months.
• Bone metabolic disease and/or taking medications that affect bone metabolism.
• History of malignancy, radiotherapy or chemotherapy.
• Pregnant or lactating women.
• Smokers

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abeer Hakam

OTHER

Sponsor Role: lead

Responsible Party

Abeer Hakam

Assistant professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Abeer Hakam

Role: CONTACT

abeer.hakam@dubaihealth.ac.ae

3053353797

References

Hamzacebi B, Oduncuoglu B, Alaaddinoglu EE. Treatment of Peri-implant Bone Defects with Platelet-Rich Fibrin. Int J Periodontics Restorative Dent. 2015 May-Jun;35(3):415-22. doi: 10.11607/prd.1861.

Reference Type: BACKGROUND

PMID: 25909530 (View on PubMed)

Other Identifiers

MBRU IRB-2024-563

Identifier Type: -

Identifier Source: org_study_id