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OpenTrials
Completed

NCT Number: NCT03142828

Implant Healing Abutment and Chlorhexidine

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.

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Key information

Conditions

Periimplantitis Mouth Diseases Peri-Implantitis Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Odontologic Universitary Clinic

Murcia, 30008, Spain

About this study

Once the implants are integrated, and given the consent, the patients will be operated to connect the healing abutments as they come from the manufacturer (Mozo Grau, Ticare®). Patients will follow the study protocol in 2 arms.

The random distribution is made prior to assignment following the internet program https://www.random.org

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Chlorhexidine

Drug

Healing abutment with Clorhexidine

Other names: CHX

Placebo

Other

Healing abutment without any antiseptic

Primary outcomes

  1. Degree of inflammation

    Time frame: 1 month after second surgery

    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.

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Official study title

Effect of the Application of Chlorhexidine in the Pillars of Implant Healing to Prevent Plate Accumulation. Controlled Random Blind Clinical Study.

Acronym: CHX-HA

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 5, 2017
Registry last updated
Nov 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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