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CTRI Number  CTRI/2025/07/090614 [Registered on: 09/07/2025] Trial Registered Prospectively
Last Modified On: 07/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The effect of a post-operative telephonic follow-up conducted by an oral surgeon, on patient satisfaction among those undergoing minor oral surgical procedures at a specialized dental hospital in a Karnataka coastal district 
Scientific Title of Study   Effectiveness of oral surgeon-led post-operative telephonic follow-up on the patient satisfaction among the patients undergoing minor oral surgical procedures in a tertiary care dental hospital in a coastal district of Karnataka- A randomised controlled study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sree Hari 
Designation  Post-Graduate 
Affiliation  Manipal College Of Dental Sciences,Mangalore 
Address  Department of Oral and Maxillofacial Surgery,Room No:2, Manipal College of Dental Sciences, Light House Hill Road, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  7012609808  
Fax    
Email  sreeh298@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Joanna Baptist 
Designation  Associate Professor 
Affiliation  Manipal College Of Dental Sciences, Mangalore 
Address  Department of Oral and Maxillofacial Surgery,Room No:2, Manipal College of Dental Sciences, Light House Hill Road, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9480528512  
Fax    
Email  joanna.baptist@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Sree Hari 
Designation  Post-Graduate 
Affiliation  Manipal College Of Dental Sciences,Mangalore 
Address  Department of Oral and Maxillofacial Surgery,Room No:2, Manipal College of Dental Sciences, Light House Hill Road, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  7012609808  
Fax    
Email  sreeh298@gmail.com  
 
Source of Monetary or Material Support  
Department of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka- INDIA 576104 
self funded 
 
Primary Sponsor  
Name  Sreehari 
Address  Department of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka- INDIA 576104 
Type of Sponsor  Other [self funded] 
 
Details of Secondary Sponsor  
Name  Address 
Manipal college of dental sciences Mangalore  Department of Oral and Maxillofacial Surgery,Room No:2, Manipal College of Dental Sciences, Light House Hill Road, Mangalore Dakshina Kannada KARNATAKA 575001 India  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sree hari  Manipal College of Dental Sceinces,Mangalore  Department of Oral and Maxillofacial Surgery,Room No:2, Manipal College of Dental Sciences, Light House Hill Road, Mangalore
Dakshina Kannada
KARNATAKA 		 7012609808

sreeh298@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
instituitional ethics committee MCODS,MANGALORE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Non telephonic survey  No follow up calls will done to know the satisaction of the patents undergoing minor oral surgical procedures.This study will be carried out for period of 18 months. 
Intervention  telephonic survey  telephonic follow up calls to know the patient satisfaction after undergoing minor oral surgical procedures.This study will be carried out for period of 18 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. All Surgical out-patients of 18 years and above undergoing any minor oral surgical procedure under local anaesthesia
2. Patients giving written informed consent to participate in the study
3. Minor surgical procedures under local anaesthesia that does not require hospitalisation or day care facility
 
 
ExclusionCriteria 
Details  1. Patients who are not willing to share their telephone number with the treating doctor or don’t have a telephone number
2. Admitted patients undergoing minor surgical procedures for any reasons
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess effectiveness of oral surgeon-led post-telephonic follow-up on the patient satisfaction among the patients undergoing minor oral surgical procedure in a tertiary care dental hospital  Baseline and 1 week Post op 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the improvement in patient compliance among healthcare professional-led post operative telephonic follow up group as compared to patients receiving current post-op standard of care.  1 week Post op 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   30/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  As a peer reviewed Publication

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Title: Effectiveness of oral surgeon-led post-operative telephonic follow-up on the patient satisfaction among the patients undergoing minor oral surgical procedures in a tertiary care dental hospital in a coastal district of Karnataka – A randomised controlled trial

Introduction:

A non-adherence to clinical recommendation is challenging issue in out-patient follow up during post op period. This issue is not limited to certain medical specialities or medical cohort. Poor patient compliance towards following post operative instructions and medications may result in poor health outcome. Follow up visits are essential for surgical patients to monitor wound healing.

Patients who have undergone minor surgical procedures and return home the same day have multiple queries regarding pain, bleeding from surgical site, doubts regarding medication etc.

A study conducted by Sarah et al aimed to assess the effect of post procedure personalised telephone call that showed a better compliance in subsequent post-discharge appointments.[ss1] (1) Presently,  standard of care is to contact the department clinic landline telephone or visit the OPD clinic by the patient during working hours and visit emergency department after working hours in case of need. Currently, it is not mandatory to share contact number between patient and doctors for clearing the patient queries peri-operatively. Hence most often we cannot resolve the queries regarding post operative instructions and medications which can negatively affect patient compliance and may also compromise desired healing outcome.

This study is designed to assess the patient satisfaction and treatment outcome with and without post operative oral surgeon led telephonic follow up. Patient compliance and addressing patient queries during post op period by sharing telephone numbers between patient and the treating doctors and this will be compared with patients being given standard of care.

 

Aim:

To assess Effectiveness of oral surgeon-led post-telephonic follow-up on the patient satisfaction among the patients undergoing any minor oral surgical procedures in a tertiary care dental hospital in a coastal district of Karnataka.

 

 

 

Objectives:

PRIMARY: To assess effectiveness of oral surgeon-led post-telephonic follow-up on the patient satisfaction among the patients undergoing any minor oral surgical procedure in a tertiary care dental hospital

SECONDARY: To determine the improvement in patient compliance among healthcare professional-led post operative telephonic follow up group as compared to patients receiving current post-op standard of care

METHODOLOGY:

·       STUDY DESIGN: A randomised controlled trial

·       STUDY DURATION: The study period will be 18 months.

·       STUDY SETTING: The study will be conducted in the Department of Oral and Maxillofacial Surgery, Manipal College of Dental Sciences, Lighthouse outpatient department.

·       STUDY POPULATION: The study is conducted among the patients who are undergoing any minor oral surgical procedures.

INCLUSION CRITERIA:

1.    All Surgical out-patients of 18 years and above undergoing any minor oral surgical procedure under local anaesthesia

2.    Patients giving written informed consent to participate in the study

3.    Minor surgical procedures under local anaesthesia that does not require hospitalisation or day care facility

EXCLUSION CRITERIA:  

1.    Patients who are not willing to share their telephone number with the treating doctor or don’t have a telephone number

2.    Admitted patients undergoing minor surgical procedures for any reasons

 

·       SAMPLE SIZE AND SAMPLING:

According to Tokedde.B et al (2023),the mean (SD) patient satisfaction score at the end of 7 days after a dental procedure with pain management in the group which received telephonic calls was 8.9(2.0) and in the control group was 8.6(2.2). Considering, a mean difference of at least 1 unit in the patient satisfaction score between two groups, we need a minimum sample of 70 patients in each group that is a total of 140 patients to achieve the outcome with a pooled standard deviation of 2.1 units, a power of 80% and 95% confidence intervals. The sample size is calculated using an online sample size calculator for two independent means “statulator” (2)

SAMPLING METHOD:

A total of 140 patients will be recruited for the study . A random number sequence will be generated using an an online software (sealed envelope) and the patients will be randomised into interventional group and control group with a block size of 4 and 6 (block randomisation technique).A sealed envelope technique for allocation concealment will be adopted.The random number sequence will be generated by a person who is not a part of the study.The randomisation and allocation concealement will be done by a junior resident of dept of omfs who is not the part of the study. the control group  will receive the basic care (STANDARD OF CARE) and the Intervention group  will receive the telephonic follow up by the treating oral surgeon.

 

STUDY PROCEDURE:

In the present study, patients undergoing minor surgical procedures over a 18-month period of time in the Department of oral surgery of the MCODS Mangalore were included. Patients will be randomly assigned to intervention and control groups. Intervention group will be monitored by telephone follow-up, whereas the control group will be taken care as per standard of care in the department. Minor oral surgical procedure , post telephonic follow up will be done by the principal investigator. Patients of both groups will be examined for post extraction wound healing and patient satisfaction at the time of suture removal (8 to 10 days following surgery) at the outpatient clinic by the blinded co principal investigator.

On the first visit the patients will be explained about the procedure, alternative treatments if any and follow-up visits. Patients that fulfil the inclusion criteria and are willing to participate in the study will be included. A detailed case history of the patient will be recorded followed by taking informed written consent for the procedure. All case group patients will be provided with treating doctor’s phone number and their phone number will be collected.  Control group patients will be given hospital number to contact and asked to come to the OPD/Casualty in case of need. All minor surgical procedures will be performed under local anesthesia according to standard protocol in oral surgery department. All patients will receive the appropriate post-operative instructions. Case group patients will be contacted by phone on the day of surgery and third day after surgery by the treating doctor. The treating doctor will again give the appropriate post op instructions and clarify any queries by the patient during the telephonic conversation. All patients in both groups will be recalled between day 7 to 10 postoperatively. All patients will be asked to fill in a questionnaire that will include questions regarding patient satisfaction and will be checked for healing of the surgical site assessed by the healing criteria given in Annexure -III

A questionnaire will be filled out to report any possible wound problems or any other information during the week after surgery which could indicate the presence of post-operative complications or problems prior to examination. 

STUDY TOOL AND VARIABLES:

Pre-designed, structured study tool will be made. Section A will include demographic data of the patient like name, age, profession of the patient etc. There are no questions about the subject’s personal details to maintain their anonymity. Section B contains clinical details of the patient like medical history, post procedure complications if any, etc. Section C will contain patient satisfaction assessment. Section D will contain questions related to patient compliance.

STASTICAL ANALYSIS:

Data collected will be entered in MS excel and analysis will be done in SPSS v.22. Descriptive analysis will be carried out. Variables like age, duration of hospital stay, patient satisfaction score will be expressed as mean (SD)/Median (IQR). The baseline and post follow-up improvement in the patient satisfaction score and across the two groups will be assessed by repeated measure ANOVA.

The compliance rate across two groups will be expressed as proportions and percentages. The difference in proportion across two groups will be assessed by chi-square test of association. All statistical significance will be attributed to p<0.05.

ENDPOINT AND OUTCOME:

 Endpoint:

The primary endpoint for the RCT is between post surgical  day 7 to 10

 Outcome:

Primary outcome : patient satisfaction across both groups

Secondary outcome : 1. perception of pain across both groups

                                   2. post op healing across both groups

                                   3. patient compliance across both groups


 
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