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Completed

NCT Number: NCT04950491

Patient-reported Outcome Measures Comparing Static Computer-aided Implant Surgery and Conventional Implant Surgery

The aim of this randomized controlled trial was to compare PROMs in patients receiving single tooth replacement in posterior sites by s-CAIS and CIS.

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Key information

Conditions

DENTAL IMPLANTATION Computer-assisted Surgery Dental Anxiety Neurologic Manifestations Oral Health Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Outcome Assessment Postoperative Complications Postoperative Pain Quality of Life Signs and Symptoms

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

About this study

Since current patient-reported outcome measures (PROMs) evidence related to static computer-aided implant surgery (s-CAIS) compared with conventional implant surgery (CIS), particularly in partial edentulous patients, were still limited. The aim of this randomized controlled trial was to compare PROMs in patients receiving single tooth replacement in posterior sites by s-CAIS and CIS.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy or well-controlled systemic disease (ASA classification I,II)
  • A partially edentulous ridge in the premolar-molar region with existing two-sided interproximal as well as antagonist contacts
  • No sign of acute oral infection
  • Periodontally healthy (or successfully treated)
  • More than 2 mm of keratinized gingiva at the site of surgery
  • Sufficient bony ridge for implant placement with or without simultaneous bone grafting

Exclusion criteria

  • Diabetes mellitus
  • Smoking more than ten cigarettes per day
  • Pregnancy
  • Psychiatric disorder
  • History of radiation therapy at head and neck area and chemotherapy
  • Bony pathologies, namely osseous dysplasia, odontogenic cyst, tumor
  • History of soft tissue grafting at the prospective implant site
  • Inadequate bony ridge with the need of bone augmentation prior to implant placement

Treatment and study plan

Modified Dental Anxiety Score (MDAS) questionnaire

Other

MDAS was used to measure the patients' anxiety toward dental treatment before implant surgery (Humphris, Dyer, &Robinson, 2009). Originally, the MDAS questionnaire included five questions answered with a 5-category Likert scale. The original MDAS questionnaire does not cover anxiety toward implant surgery. Therefore, a question enquiring about patients' feelings towards implant surgery was added.

Pain questionnaire

Other

Patients were asked to describe the worst pain feeling using a standard 10 cm Visual Analog Scale (VAS) and the proportion of time spent in severe pain using a 5 category Likert scale. The number of analgesics taken per day was also asked.

Oral Health-Related Quality of Life (OHRQoL) questionnaire

Other

The OHRQoL comprises 14 questions covering problems the patient may in three main categories: oral function, daily activity, and post-operative symptoms (Chaushu, Becker, Zeltser, Vasker, & Chaushu, 2004). Patients answered using a 5-category Likert scale.

Primary outcomes

  1. Change of post-operative pain for 7 days: Visual Analog Scale

    Time frame: Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime.

    Patients were asked to describe the worst post-operative pain feeling using a standard 10 cm Visual Analog Scale.

  2. Change of the proportion of time spent in severe pain for 7 days: 5-category Likert scale

    Time frame: Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime.

    Patients were asked to describe the proportion of time spent in severe pain using 5-category Likert scale (None, Low, Moderate, High, Very high).

  3. Change of the analgesics taken per day for 7 days: the number of tablets per day

    Time frame: Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime.

    Patients were asked to describe the number of analgesics taken per day.

  4. Change of Oral Health-Related Quality of Life (OHRQoL) for 7 days: 5-category Likert scale

    Time frame: Patients were instructed to answer the OHRQoL every day for 7 days starting from the day of surgery 1 hour before bedtime.

    The OHRQoL questionnaire comprises 14 questions covering problems the patient may in three main categories: oral function, daily activity, and post-operative symptoms derived from Chaushu's study (Chaushu, Becker, Zeltser, Vasker, & Chaushu, 2004). Patients answered this questionnaire using a 5-category Likert scale (Not at all, Very little, A little, Quite a lot, Very much).

Secondary outcomes

  1. The Modified Dental Anxiety Score (MDAS)

    Time frame: 1 day (Patients completed the modified MDAS once, while waiting for the surgery in the waiting room.)

    The MDAS was used to measure patient anxiety toward dental treatment (Humphris, Dyer, & Robinson, 2009). The MDAS consists of five questions answered with a 5-category Likert scale, ranging from 'not anxious' to 'extremely anxious'. The original MDAS questionnaire does not cover anxiety toward implant surgery. Therefore, a question enquiring about patients' feelings towards implant surgery was added.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • ITI Foundation

Registry information

Official study title

Patient-reported Outcome Measures (PROMs) Comparing Static Computer-aided Implant Surgery (s-CAIS) and Conventional Implant Surgery (CIS) for Single-tooth Replacement: A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jul 6, 2021
Registry last updated
Jul 6, 2021

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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