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

NCT04950491 | Completed

• 1 other identifier: DT 071/2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Implantation; Postoperative Pain; Computer-assisted Surgery; Patient Outcome Assessment; Dental Anxiety; Quality of Life; Oral Health

Keywords

Clinical Research; Dental Implant; Static Computer-Aided Implant Surgery (s-CAIS); Patient-Reported Outcome Measures (PROMs); Dental Anxiety; Pain; Oral Health-Related Quality of Life (OHRQoL)

Outcome Measures

Primary Outcomes (4)

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

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

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

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

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

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

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

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

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

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

  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).

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

Secondary Outcomes (1)

• The Modified Dental Anxiety Score (MDAS)

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

Study Arms (2)

Test group (s-CAIS)

EXPERIMENTAL

The test group workflow used a fully computer-guided implant surgical protocol.

Other: Modified Dental Anxiety Score (MDAS) questionnaire; Other: Pain questionnaire; Other: Oral Health-Related Quality of Life (OHRQoL) questionnaire

Control group (CIS)

OTHER

The control group workflow used a conventional implant surgical protocol.

Other: Modified Dental Anxiety Score (MDAS) questionnaire; Other: Pain questionnaire; Other: Oral Health-Related Quality of Life (OHRQoL) questionnaire

Interventions

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.

Control group (CIS); Test group (s-CAIS)

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.

Control group (CIS); Test group (s-CAIS)

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.

Control group (CIS); Test group (s-CAIS)

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead
• ITI Foundation: collaborator

Study Sites (1)

Faculty of Dentistry, Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

Location

Related Publications (27)

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• Coolidge T, Hillstead MB, Farjo N, Weinstein P, Coldwell SE. Additional psychometric data for the Spanish Modified Dental Anxiety Scale, and psychometric data for a Spanish version of the Revised Dental Beliefs Survey. BMC Oral Health. 2010 May 13;10:12. doi: 10.1186/1472-6831-10-12.

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  PMID: 18364045 BACKGROUND

• Chaushu S, Becker A, Zeltser R, Vasker N, Chaushu G. Patients' perceptions of recovery after surgical exposure of impacted maxillary teeth treated with an open-eruption surgical-orthodontic technique. Eur J Orthod. 2004 Dec;26(6):591-6. doi: 10.1093/ejo/26.6.591.

  PMID: 15650068 RESULT

• Humphris GM, Dyer TA, Robinson PG. The modified dental anxiety scale: UK general public population norms in 2008 with further psychometrics and effects of age. BMC Oral Health. 2009 Aug 26;9:20. doi: 10.1186/1472-6831-9-20.

  PMID: 19709436 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Surveys and Questionnaires; Quality of Life

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Health Status; Demography; Epidemiologic Measurements

Study Officials

• Chatchai Kunavisarut, DDS

  Department of Advanced General Dentistry, Faculty of Dentistry

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Dental Surgery

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 6, 2021
• Study Start: July 9, 2019
• Primary Completion: November 27, 2020
• Study Completion: March 11, 2021
• Last Updated: July 6, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)