0.2% Chx Gel vs Implant Bacterial Contamination

NCT ID: NCT03431766

Last Updated: 2018-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-17
• Study Completion Date: 2019-06-30

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.

Detailed Description

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. The randomization of this prospective, randomized-controlled, double blind study was obtained using computer generated random numbers, centralized with sequentially sealed opaque envelopes provided by the study adviser.The surgeon will open the sealed envelope containing the randomized group only after having inserted the implant.During the first evaluation, all subjects will be clinically examined: radiographs, plaque and bleeding scores would be carried out for diagnostic evaluation; then the patients would be scheduled for surgery procedures. All Implants (Cortex classic, Shalomi, Israel) would be inserted by two skilled operators who will follow a two-stage protocol and would place them according to the manufacturer's instructions. Before surgery all the patients would be subject to applications of chlorhexidine digluconate solution 0.2% for 2 minutes to obtain lower bacterial load and local anesthesia would be given with Articaine® (Ubistesin 4% - Espe Dental AG Seefeld, Germany) associated with epinephrine (1:100.000). Eventually, all patients would 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) would be used. The two gels are perfectly alike in packaging, colour and smell and nobody knows the exact location of placebo or test gel, which would be revealed, only after data collection would be performed, by the person who prepared them. A or B gel would 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. All patients will recieve antibiotic therapy, 2g/day for 6 days (Augumentin®; Glaxo-Smithkline Beecham, Brentford, UK).The post-operative pain would be controlled with NSAIDs, and oral hygiene instructions would be given. Both gels would 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.

Conditions

Bone Resorption; Bacteria Caused Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

control group A

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.

Group Type: PLACEBO_COMPARATOR

placebo gel

Intervention Type: 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.

test group B

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.

Group Type: EXPERIMENTAL

0.20% chlorhexidine gel

Intervention Type: 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.

Interventions

placebo gel

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.

Intervention Type: DEVICE

0.20% chlorhexidine gel

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

G. d'Annunzio University

OTHER

Sponsor Role: lead

Responsible Party

Michele Paolantonio

full time professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sergio caputi, MD, DDS

Role: PRINCIPAL_INVESTIGATOR

g. d'annunzio chieti-pescara university

Locations

G. d'Annunzio University

Chieti, CH, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

bruna sinjari, dds, phd

Role: CONTACT

b.sinjari@unich.it

+393927471479

Facility Contacts

sergio caputi, MD; DDS

Role: primary

scaputi@unich.it

+393927471479

References

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.

Reference Type: DERIVED

PMID: 30410934 (View on PubMed)

Other Identifiers

2342

Identifier Type: -

Identifier Source: org_study_id