Implant Healing Abutment and Chlorhexidine

NCT03142828 | Completed Phase 4 DMC

• 1 other identifier: 1366/2016
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The work hyposesis is based on the application of a chlorhexidine gel against the non-application on the healing abutments in patients who have received a submerged titanium implant to check its effect on healing and prevention of bacterial plaque accumulation during a period of 1 month.

Conditions

Periimplantitis

Keywords

chlorhexidine, dental implant, in-situ drug delivery,

Outcome Measures

Primary Outcomes (1)

• Degree of inflammation

  Degree of inflammation was measured using a 4-point Likert scaleInflammation 0 = non-inflamed gingiva with pale pink color. Inflammation 1 = erythematous gingiva without bleeding on manipulation. Inflammation 2 = gingiva with slight bleeding during manipulation during unscrewing or screwing of the abutment. Inflammation 3 = gingiva with heavy bleeding during manipulation during unscrewing or screwing of the abutment.

  1 month after second surgery

Study Arms (2)

Test (clorhexidine gel)

ACTIVE COMPARATOR

The healing abutments were covered by a chlorhexidine gel after the first week of the second surgery (2-stage implants).

Drug: Chlorhexidine

Placebo

PLACEBO COMPARATOR

The healing abutments were covered without any antiseptic gel after the first week of the second surgery (2-stage implants).

Other: Placebo

Interventions

Chlorhexidine DRUG

Healing abutment with Clorhexidine

Also known as: CHX

Test (clorhexidine gel)

Placebo OTHER

Healing abutment without any antiseptic

Placebo

Eligibility Criteria

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

You may qualify if:

• Good systemic health status (ASA I or II).
• No current pain.
• No use of painkillers or Anti-inflammatory drugs in the prior weeks.
• Older than 18 years.
• Oral hygiene index of ≤ 2 (Löe and Silness).
• A minimum of 2 mm of adhered gum.
• A minimum of 8 mm of vertical bone.
• A minimum of 7 mm of vestibule-lingual bone.
• Scheduled to receive a unitary implant.
• Willing to participate in this controlled study.

You may not qualify if:

• Pregnant or nursing women.
• Use of any type of medication that might affect the perception of pain.
• An history of alcohol or drug abuse.
• A requirement for guided regeneration or sinus lifting procedures.
• Failure to comply with the study protocol.

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

Odontologic Universitary Clinic

Murcia, 30008, Spain

Location

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Arturo Sánchez-Pérez, Professor

  Universidad de Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blindness performed for patients and for statistical analysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: After the first week, the healling abutment will be randomly distributed in a test group with application of chlorhexidine gel or a control group without the application of the chlorhexidine gel.

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: May 5, 2017
• Study Start: April 15, 2017
• Primary Completion: June 1, 2017
• Study Completion: November 26, 2017
• Last Updated: November 28, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the publication of the results
• Access Criteria: Any interested researcher

Locations

ES (1)