Guided Bone Regeneration of Peri-implant Defects Comparing Submerged Versus Non-submerged Healing

Guided Bone Regeneration of Peri-implant Defects Comparing Submerged Versus Non-submerged Healing: a Randomized Controlled Clinical Trial

Objective: the objective of the present randomized clinical trial is to compare changes in radiographic peri-implant bone defect fill after regeneration of peri-implant intrabony defects with a submerged versus a non-submerged protocol.

Material and Methods: this project is a randomized controlled clinical trial, double blind, with a parallel groups design. Thirty-six patients presenting with peri-implantitis subsidiary of regenerative treatment will be recruited. After subjects have been given informed consent, they will be randomized to test or control group. All patients will undergo a session of non-surgical peri-implantitis therapy consisting on prostheses removal and implant debridement with ultrasounds, curettes and air-abrasive under local anaesthesia. Patients in test group will have their prostheses removed and the mucosa surrounding the affected implants will be let heal covering the implants, while patients in control group will have their prostheses installed again after the non-surgical therapy. Six to eight weeks later, all subjects will undergo regenerative treatment with the use of a bone substitute, a collagen membrane and fixation pins, and in control group tissues will heal following the non-submerged protocol, meanwhile subjects in test group will undergo submerged healing. Six months later, subjects in test group will have their prostheses reconnected to the regenerated implants. All patients will undergo periodontal and peri-implant maintenance therapy every three months during follow-up. Radiographic assessment of vertical bone level changes (primary outcome), clinical status of peri-implant tissues, changes in soft tissues margin, patient related outcomes and adverse events will be assessed at 3, 6 and 12 months after peri-implantitis regenerative surgery.

Study Overview

• Status: Unknown
• Conditions: Peri-Implantitis
• Intervention / Treatment: Procedure: Submerged healing; Procedure: Non-submerged healing

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Dental School, University Complutense of Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients diagnosed of peri-implantitis requiring surgical therapy
• The periapical radiographic study demonstrates an intra-bony component greater than 3 mm at the affected implant
• There is at least 2 mm of keratinized mucosa around the affected implant
• Intrasurgically, peri-implant defects must be type Ia, Ib, Ic and Ie (according to Schwarz et al. 2007)
• Affected implants must be two-piece implants to allow for the submerged protocol
• Affected implant supported restorations must be screw-retained or cemented, and should allow for prostheses removal

Exclusion Criteria:

• Patients with untreated periodontitis
• Medical conditions requiring prolonged use of steroids and/or medications that can interfere with bone metabolism
• Metabolic disorders such as osteoporosis
• History of uncontrolled endocrine disorders
• History of leukocyte dysfunction and deficiencies
• History of immunodeficiency syndromes
• History of neoplastic disease requiring the use of radiation of chemotherapy
• History of renal failure
• Physical handicaps that would interfere with the ability to perform adequate oral hygiene
• Alcoholism or drug abuse
• Smokers of more than 10 cigarettes per day, cigar equivalents or tobacco chewers
• Any other condition or circumstance that, in the opinion of the investigator, would prevent completion of study participation or interfere with the analysis of the study results, such as history of non-compliance or unreliability

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Submerged healing; Bone regeneration of peri-implantitis defects following a submerged healing	Procedure: Submerged healing; Bone regeneration of peri-implantitis defects using a bone xenograft and a resorbable collagen membrane, with flap suturing using a submerged healing protocol
ACTIVE_COMPARATOR: Non-submerged healing; Bone regeneration of peri-implantitis defects following a non-submerged healing	Procedure: Non-submerged healing; Bone regeneration of peri-implantitis defects using a bone xenograft and a resorbable collagen membrane, with flap suturing using a non-submerged healing protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in radiographic bone fill	Changes in radiographic bone fill measured from the implant shoulder to the first bone to implant contact with ImageJ software, in parallelized periapical x-rays with individual silicone bite blocks	Baseline, 3 months, 6 months and 12 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in pocket probing depth	Depth of the peri-implant sulcus/pocket measured in millimeters with a 15-UNC (University of North Carolina) periodontal probe, at six sites per implant without the crown	At baseline, after non-surgical therapy, 6 months and 12 months post-surgery
Changes in bone probing depth	Distance from the mucosal margin to the peri-implant bone measured in millimeters with a 15-UNC (University of North Carolina) periodontal probe under local anesthesia, at six sites per implant without the crown	At baseline, after non-surgical therapy and 12 months post-surgery
Changes in modified plaque index	Presence or absence of plaque assessed at six sites per tooth/implant in the whole mouth, excluding third molars	At baseline, after non-surgical therapy, 6 months and 12 months post-surgery
Changes in full mouth bleeding scores	Presence or absence of bleeding after probing with a 15-UNC (University of North Carolina) periodontal probe, assessed at six sites per tooth/implant in the whole mouth, excluding third molars. The presence of bleeding in each site will be scored 1, and the absence of bleeding will be scored 0. Full mouth bleeding score will be expressed in percentage and calculated as follows: number of sites bleeding / number of sites explored ^ 100	At baseline, after non-surgical therapy, 6 months and 12 months post-surgery
Soft tissue healing scores	Extent of soft tissue healing after surgery following Landry et al. Healing Index (1988): Healing index 1 - Very Poor; Healing index 2 - Poor; Healing index 3 - Good; Healing index 4 - Very good; Healing index 5 - Excellent	1 week, 2 weeks and 4 weeks post-surgery
Pain assessment	Participants´ subjective pain assessed using a Visual Analogue Scale (VAS) with ratings from 0-10, whereof 0 = no pain and 10 = very intense.	1 week, 2 weeks and 4 weeks post-surgery
Oral Health Impact Profile (OHIP-14)	Self-reported dysfunction, discomfort and disability attributed to the participants´ oral condition	Baseline, 3 months, 6 months and 12 months post-surgery
Adverse events´ occurrence	Occurrence of any untoward, undesired or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a subject participant in the clinical investigation. The event does not nee to be casually related to the cliinical investigation	Up to 12 months post-surgery

Collaborators and Investigators

• Sponsor: Ana Molina Villar
• Investigators: Principal Investigator: Mariano Sanz, MD DDS DrMed, University Complutense of Madrid

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2019
• Primary Completion (ANTICIPATED): May 1, 2021
• Study Completion (ANTICIPATED): May 1, 2021

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (ACTUAL): April 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Dental Implants; Peri-Implantitis; Bone Regeneration; Peri-Implant Diseases; Submerged Healing; Non-Submerged Healing
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis
• Other Study ID Numbers: 18/575-R_X

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No