Sterile versus Aseptic treatment in Dento-Alveolar Surgery*

Sterile versus Aseptic treatment in Dento-Alveolar Surgery* - SADA

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53179

Enrollment

2775

Registered

2023-04-13

Start date

2024-03-01

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-sterile gloves versus sterile gloves post-operative infection

Interventions

Sterile versus unsterile gloves/materials

Eligibility

Age

16 Years to 99 Years

Inclusion criteria

Inclusion criteria: All patients who are eligible for dento-alveolar surgery (removal of one or more teeth) and can/want to undergo this treatment. • Older or equal to 16 years • ASA I, II or III • Patient can understand and sign informed consent

Exclusion criteria

Exclusion criteria: Exclusion Criteria • Younger than 16 or not mentally competent/authorised. • ASA IV or immunocompromised patients / using immunocompromising drugs. • Indication for pre-/post-operative antibiotic use • Postoperative antibiotic use for reasons other than postoperative infection. • Patients who are unable to understand the explanations given, to read information leaflets and/or to report back any post-operative information

Design outcomes

Primary

Measure	Time frame
Primary Objective: Predictor: Use of sterile surgical gloves versus non-sterile gloves in dentoalveolar procedures. Outcome: Postoperative wound infection. Objective: To exclude an increased risk (>=3%) of postoperative wound infection after dentoalveolar surgery with non-sterile gloves compared to sterile gloves. H0: There is an increased chance of >=3% of postoperative infection when using non-sterile gloves compared to sterile gloves. H1: There is a	—

Measure

Time frame

Primary Objective: Predictor: Use of sterile surgical gloves versus non-sterile gloves in dentoalveolar procedures. Outcome: Postoperative wound infection. Objective: To exclude an increased risk (>=3%) of postoperative wound infection after dentoalveolar surgery with non-sterile gloves compared to sterile gloves. H0: There is an increased chance of >=3% of postoperative infection when using non-sterile gloves compared to sterile gloves. H1: There is a

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Secondary

Measure	Time frame
Secondary Objective(s): Predictor: Use of sterile gloves versus non-sterile aseptic gloves in dento-alveolar procedures. Outcomes: Alveolitis, delayed wound healing, postoperative pain, after-effects. Objective: To demonstrate or rule out a difference in postoperative after-effects after dento-alveolar surgery with sterile materials versus non-sterile gloves. Predictor: Use of sterile gloves versus non-sterile clean gloves. Outcomes: Torn or perforated gloves. Objective: To demonstrate the safety of non-sterile operator and assistant gloves	—

Measure

Time frame

Secondary Objective(s): Predictor: Use of sterile gloves versus non-sterile aseptic gloves in dento-alveolar procedures. Outcomes: Alveolitis, delayed wound healing, postoperative pain, after-effects. Objective: To demonstrate or rule out a difference in postoperative after-effects after dento-alveolar surgery with sterile materials versus non-sterile gloves. Predictor: Use of sterile gloves versus non-sterile clean gloves. Outcomes: Torn or perforated gloves. Objective: To demonstrate the safety of non-sterile operator and assistant gloves

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Countries

Netherlands

Contacts

Public ContactJ.P. Verweij

Amphia Ziekenhuis

jverweij@amphia.nl0765950000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)