0.2% Chx Gel vs Implant Bacterial Contamination

NCT03431766 | Unknown

• 1 other identifier: 2342
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this human randomized, double blind, placebo-control (RDBPC) study is to evaluate the efficacy of a 0.2% chlorhexidine (CHX) gel on reducing bacterial load and peri-implant inflammation at implant-abutment interface during the early healing stage.Thirty-six healthy patients (mean age 52,28 years; range 29-75 years) without a significant past medical anamnesis, all non-smokers, will be recruited as candidates for single implant placement and prosthetic rehabilitation.Patients will be randomly divided in group A (control) and group B (test) as indicated by the randomization chart. All Implants (Cortex classic, Shalomi, Israel)would be inserted by two skilled operators who followed a two-stage protocol and placed them according to the manufacturer's instructions.Eventually, all patients will be rehabilitated with a single implant-supported crown. During all the stages either a gel containing 0.20% CHX (Plak ®Gel; Polifarma Wellness Srl, Rome, Italy) or a placebo gel (Placebo, Polifarma Wellness Srl, Rome, Italy) will be used. The two gels are perfectly alike in packaging, color and smell and nobody knew the exact location of placebo or test gel, which will be revealed, only after data collection would be performed, by the person who prepared them. A or B gel will be placed on the internal connection abutments and then a cover screw would be inserted. Finally, the site would be sutured with non-absorbable nylon sutures. Cone Beam Computed Tomography evaluation (CBCT) (VatechIpax 3D PCH-6500, Fort Lee, NJ USA) would be performed both for pre-operative and post-surgical implant placement. Both gels will be given to the patients, according to the protocol, and applied 2 times/day until suture removal after 7 days. Soft tissue biopsies would be performed by means of a circular scalpel (5.5 mm in diameter) at the implant insertion (T0) and after two months of healing (second stage surgery)(T1) to analyze the peri-implant inflammatory infiltrate and the micro-vessel density (MVD) in both groups. All the radiographs taken during the study time points would be analysed to measure the bone resorption after 1 year or on other studt time points.

Conditions

Bone Resorption; Bacteria Caused Disease

Keywords

chlorhexidine gel; dental implant

Outcome Measures

Primary Outcomes (1)

• bone resorption around dental implants on both study groups

  The bone resorption will be measured on periapical radiographs that would be taken during the clinical phases of the study. It would be used also an individual bite block to assure the reproducibility of the same position during all the phases. The distance between the crestal bone level and the first point where the bone attaches to the implant will be measured. The measurements will be in millimetres.

  1 year after implant placement

Secondary Outcomes (1)

• Microbiological quantitative evaluation, bacteria count cfu/ml

  3 months after implant placement

Study Arms (2)

control group A

PLACEBO COMPARATOR

on this group a placebo gel will be applied on the internal surface of the implant during all the surgical and prosthetic phases of the treatment.

Device: placebo gel

test group B

EXPERIMENTAL

on this group a 0.20% chlorhexidine gel will be applied on the internal surface of the implant during all the surgical and prosthetic phases of the treatment described on the study protocol.

Device: 0.20% chlorhexidine gel

Interventions

placebo gel DEVICE

On control group A once the dental implants are inserted on both mandible or maxilla of the patient placebo (group A) would be applied on the internal surface of the implants on all the surgical or prosthetic phases of the study.

control group A

0.20% chlorhexidine gel DEVICE

On test group B once the dental implants are inserted on both mandible or maxilla of the patient a 0.20% chlorhexidine gel would be applied on the internal surface of the implants on all the surgical or prosthetic phases of the study.

test group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients of both sex between 18 and 75 years,
• good systemic and oral health,
• need of single crown implant supported restoration,
• at least six months of healing after tooth extraction,
• cortical bone thickness \> 5 mm measured by means of a cone beam computed tomography (CBCT).

You may not qualify if:

• poor oral hygiene,
• active periodontal disease or other oral disorders,
• insufficient bone thickness for implant insertion,
• bone augmentation procedures,
• immediate loading protocols,
• uncontrolled diabetes mellitus,
• immune diseases,
• smoking
• bruxism.

Sponsors & Collaborators

• G. d'Annunzio University: lead

Study Sites (1)

G. d'Annunzio University

Chieti, CH, 66100, Italy

RECRUITING

Related Publications (1)

• Sinjari B, D'Addazio G, De Tullio I, Traini T, Caputi S. Peri-Implant Bone Resorption during Healing Abutment Placement: The Effect of a 0.20% Chlorhexidine Gel vs. Placebo-A Randomized Double Blind Controlled Human Study. Biomed Res Int. 2018 Oct 16;2018:5326340. doi: 10.1155/2018/5326340. eCollection 2018.

  PMID: 30410934 DERIVED

MeSH Terms

Conditions

Bone Resorption; Bacterial Infections

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Bacterial Infections and Mycoses; Infections

Study Officials

• Sergio caputi, MD, DDS

  g. d'annunzio chieti-pescara university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

bruna sinjari, dds, phd

CONTACT

+393927471479; b.sinjari@unich.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: full time professor

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: February 13, 2018
• Study Start: November 17, 2015
• Primary Completion: January 12, 2019
• Study Completion: June 30, 2019
• Last Updated: February 13, 2018

Record last verified: 2018-02

Locations

IT (1)