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

NCT03900741 | Unknown

• 1 other identifier: 18/575-R_X
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peri-Implantitis

Keywords

Peri-Implantitis; Peri-Implant Diseases; Bone Regeneration; Submerged Healing; Non-Submerged Healing; Dental Implants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Changes in pocket probing depth

  At baseline, after non-surgical therapy, 6 months and 12 months post-surgery

• Changes in bone probing depth

  At baseline, after non-surgical therapy and 12 months post-surgery

• Changes in modified plaque index

  At baseline, after non-surgical therapy, 6 months and 12 months post-surgery

• Changes in full mouth bleeding scores

  At baseline, after non-surgical therapy, 6 months and 12 months post-surgery

• Soft tissue healing scores

  1 week, 2 weeks and 4 weeks post-surgery

Study Arms (2)

Submerged healing

EXPERIMENTAL

Bone regeneration of peri-implantitis defects following a submerged healing

Procedure: Submerged healing

Non-submerged healing

ACTIVE COMPARATOR

Bone regeneration of peri-implantitis defects following a non-submerged healing

Procedure: Non-submerged healing

Interventions

Submerged healing PROCEDURE

Bone regeneration of peri-implantitis defects using a bone xenograft and a resorbable collagen membrane, with flap suturing using a submerged healing protocol

Submerged healing

Non-submerged healing PROCEDURE

Bone regeneration of peri-implantitis defects using a bone xenograft and a resorbable collagen membrane, with flap suturing using a non-submerged healing protocol

Non-submerged healing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ana Molina Villar: lead

Study Sites (1)

Dental School, University Complutense of Madrid

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mariano Sanz, MD DDS DrMed

  University Complutense of Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Molina, MSc

CONTACT

0034647486381; ar.molina@ucm.es

Fernando Noguerol, MSc

CONTACT

0034639812572; fernoguerolsicilia@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 3, 2019
• Study Start: April 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)