effect of locally delivered drug after extraction to control pain and infection without taking oral tablets
- Conditions
- Other and unspecified diseases ofpulp and periapical tissues,
- Registration Number
- CTRI/2022/06/043178
- Lead Sponsor
- chandra kiran Venkata sai pathuri
- Brief Summary
Title: “Efficacy of local drug delivery system in minimizing the
systemic administration of postoperative medicationâ€
Principal Investigator: Chandra Kiran Venkata Sai Pathuri Department of Oral and Maxillofacial Surgery
Sibar institute of dental sciences, Guntur
Introduction:
Extractions are most common surgical procedures performed by oral and maxillofacial surgeon.[2] The premise of successful exodontic surgical treatment is based not only on the correct operative technique but also on the prevention and management of postoperative complications.[3] Common post-operative complications associated with extraction are pain and infection.[2] Post extraction pain has often been a nemesis for dental surgeon [3]
According to the International Association for the Study of Pain, pain is defined as “Unpleasant sensory and emotional experience associated with actual or potential tissue damage.†Pain after extraction is a common complication. Pain is common body response to wound anywhere in the body. Post extraction pain occurs in extraction wound as it is not different from other body wound, and this pain result from the inflammation at the site of extraction which is a part of normal wound healing. [1]
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Antibiotics are commonly administered whether oral parenteral to reduce the chances of postoperative infection of extraction site. Pencillins are most frequently used antibiotics for preventing socket infection[2]
NSAIDS are most preferred class of drugs prescribed post treatment and administration of such drugs through oral route has increased risk of varying adverse effects [4]
There are various routes of drug administration, but the main aim is to relieve pain, improve comfort and promote wound healing in a way which is best tolerated by the patient. Oral and parenteral are the commonly used routes of drug administration. Both oral & parenteral routes are associated with significant no: of problems like patient compliance, gastrointestinal disturbance and pain.[2]
Therefore, local drug delivery have been developed as a painless, non-invasive and effective route of drug delivery system ad takes precedence over other routes in terms of compliance.
Local drug delivery at the site of surgery has potential of having advantages of antibiotic and NSAIDS without the major short comings of oral/parenteral administration. The zero- order release kinetics of antibiotics from local delivery systems may be very attractive to prevent development of antibiotic resistance[2]
Local drug delivery route is preferred over other routes as
It avoids the first-pass metabolism, thereby increasing the bioavailability of the drug, with sustained release into the blood
Reduces the gastro-intestinal adverse effects
Relieves the pain while administration
Also enhances ease of application, patient’s compliance and comfort.
And also promotes better wound healing with minimal dose of drug.
The purpose of the study is to evaluate the efficacy of local drug delivery as an effective route of drug administration which enhances patient’s compliance and with no additional adverse effects when compared to conventional modes of administration.
REVIEW OF LITERATURE:
Vinay patil et al (2021) conducted a comparative prospective study to evaluate the effects of intraoperative placement of tetracycline, tetracycline + gelatin sponge and placebo on postoperative pain after mandibular molar extraction and concluded that tetracycline and gelatin sponge intrasocket placement provides a good substitute to the prolong use of analgesics and as a good adjuvant in reducing pain in the first few days after routine dental extraction.
Dinesh verma et al (2021) conducted a split mouth randomized clinical trial study to evaluate the effectiveness of amoxicillin and clavulanic acid impregnated plaster of paris beads for prevention of infection of third molar extraction sockets and concluded that amoxicillin with clavulanic acid impregnated pop beads appears to be as effective as oral regimen for prevention of socket infection
Ajay k Pillai et al (2021) conducted a study to evaluate the effect of platelet rich fibrin (PRF) gel as vehicle for delivery of diclofenac sodium following transalveolar extraction of impacted mandibular third molar. In experimental group PRF gel with diclofenac sodium was placed in extraction socket. The clinical parameters especially the postoperative pain, swelling, interincisial distance, wound dehiscence, dry socket, soft tissue healing and infection which were assessed on 1st , 3rd and 7th day following surgical disimpaction and concluded that the use of simple, cost-effective method of autologous PRP gel as vehicle to localised deliver diclofenac sodium may be beneficial to enhance the wound healing process, promotes bone regeneration and reduced pain.
Karthik kp et al (2020) conducted a study to compare anti-inflammatory properties of ibuprofen using two drug delivery systems after third molar surgery using chitosan microspheres as a carrier for local drug delivery in to third molar socket and through the oral route and concluded that ibuprofen incorporated chitosan based microspheres had comparatively better analgesic and anti-inflammatory properties with drastic reduction in pain, swelling, trismus and also had a reliable wound healing property when compared with orallyadministered ibuprofen after mandibular third molar surgery
Suzuki T et al (2018) conducted a randomized, single blind, dose response, controlled, clinical study to evaluate the efficacy, safety and appropriate dose of the sustained-release lidocaine sheet for pain following tooth extraction on a total of 94 patients and concluded that administration of sustained release lidocaine sheet at 100mg may have clinical therapeutic potential for pain relief following tooth extraction.
AIMS AND OBJECTIVES:
- AIM: To assess and compare the efficacy of local drug delivery
and systemic drug delivery following dental extractions
Objectives:
a)To assess pain between study and control groups
2. b) To assess comfort between study and control group
3. c) To assess wound healing between study and control group
4. d) To compare pain, comfort and wound healing between two groups
Materials & Methods:
The study will be conducted on outpatients reporting to the department of oral and maxillofacial surgery, Sibar Institute of Dental Sciences,
Takkellapadu for dental extractions. Study design: A triple-blinded randomized comparative study Sampling technique: Simple random sampling. Total sample size: 140 (70 in each group)
Sample size calculation:
Software used: G\*power 3.1.9.2
Effect size = 0.5 αerror = 0.05 Power = 0.80
Allocation = 1:1 Total sample size calculated=128(64ineachgroup)
Loss of sample = 10%
Statistical analysis:
1. Descriptive statistics
2. Independent ‘t’ test
3. Repeated measures of ANOVA with posthoc tukey
test
4. Chi-square testMaterials used:
1. 1) Microspheres containing amoxicillin and clavulanic acid – 625 mg
2. 2) Microspheres containing acelofenac – 100mg
3. 3) Placebo – microspheres without any medication
4. 4) Oral placebo – tablets without any medication
5. 5) Oral amoxicillin and clavulanic acid tablets – 625 mg
as per regimen
6. 6) Oral acelofenac – 100 mg as per regimen
Inclusion criteria:
ASA 1 and ASA 2 individuals between 20-60 years of age.
Individuals tolerant to NSAID’s.
Individuals with no known pencillin allergy
Exclusion criteria:
- Patients who are on analgesics or sedatives for any other systemic issues
Patients who are on antibiotics for any other systemic issues
Procedure:
Patients reporting to the department of oral and maxillofacial surgery during the study period for dental extractions are included.
All the participants will be informed about the study and a written informed consent is obtained from all of them.
The participants will be randomized into study and control groups using lottery method. Randomization and allocation concealment will be done by the recruiter and a unique ID is generated for each participant at the same time. All the procedures will be done by the same surgeon to avoid operator bias. After the procedure, a pre- written prescription is handed over to the participants of respective groups, so that the investigator is kept blinded.
The pre-written prescription includes medicated microspheres and tablets (placebo) for the experimental group while it includes oral tablets of antibiotic, analgesic and placebo microsphere for the control group to maintain participant blinding. Rescue analgesics are also given and the patient is advised to take them only on demand.
After the procedure, the patient will be given either medicated microspheres or oral tablets as per recommended regimen along with their respective placebos included.
The parameters recorded are pain and discomfort on day 1, day 2 and day 3 using Numerical Rating Scale and Comfort Scale.And wound healing on day 7 using Landry et al Healing Index. The adverse effects are also noted, if any. Additionally, the number of rescue analgesics consumed and their frequency of cosumption will also be noted.
Follow up for assessment of parameters is done over a telephone call by the investigator using investigator administered self- rated pain scale.
Patient is recalled for a review after 7 days.
All the observations will be recorded, tabulated and analysed statistically. The statistical analyser will be provided only with the recorded data without revealing which data belongs to the study group, thereby blinding the analyser.
Blinding is maintained as long as possible throughout the study and analysis.
The participant and the biostatistician are blinded through out the study and the investigator unveils the data for inference purpose, only after the results are given by the biostatistician or the statistical analyser.
- SALIENT FEATURES OF THE STUDY DESIGN:
Allotment of unique ID for each participant. A Written informed consent for participation. Randomization into study and control groups. Allocation concealment. Triple Blinding.
Potential Risks and Benefits:
Risks: No risks involved. Benefits:
1. Ease of administration.
2. Longer duration of action when compared to other
conventional routes.
3. Flexible route of drug administration
4. Improved patient compliance and comfort.References:
1. Patil V, Ramaraj PN, Sharma M, Singh R, George A, Roy B. Effects of intraoperative placement of tetracycline, tetracycline + gelatin sponge, and placebo on postoperative pain after mandibular molar extraction: A comparative prospective study. Natl J Maxillofac Surg. 2021;12(2):211–8.
2. Verma DK, Bansal S, Pahari KC. Can Amoxicillin and Clavulanic Acid Impregnated Plaster of Paris Beads Serve as an Effective Alternative to Systemic Antibiotics for Third Molar Surgeries? A Split Mouth Randomized Clinical Trial. J Maxillofac Oral Surg [Internet]. 2021 Jul 23 [cited 2022 Feb 23];
3. Pillai AK, Thomas S, Seth S, Jain N, Chobey A. Platelet Rich Fibrin (PRF) Gel as Efficient Vehicle for Local Drug Delivery in Minor Oral Surgical Defects. :7.
4. Kp K, R B. Evaluation and comparison of anti-inflammatory properties of ibuprofen using two drug delivery systems after third molar surgery: using chitosan microspheres as a carrier for local drug delivery in to the third molar socket and through the oral route. Br J Oral Maxillofac Surg. 2021 Feb;59(2):191– 6.
5. Suzuki T, Kosugi K, Suto T, Tobe M, Tabata Y, Yokoo S, et al. Sustained-release lidocaine sheet for pain following tooth extraction: A randomized, single-blind, dose-response, controlled, clinical study of efficacy and safety. PLoS One. 2018 Jul 2;13(7):e0200059.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 140
- ASA 1 and ASA 2 individuals between 20-60 years of age.
- Individuals tolerant to NSAID’s.
- Individuals with no known pencillin allergy.
Patients who are on analgesics or sedatives for any other systemic issues Patients who are on antibiotics for any other systemic issues.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pain - will be assessed by Numerical Rating Scale(NRS) 1st day, 2nd day and 3rd day
- Secondary Outcome Measures
Name Time Method infection - will be assessed using Landry et al healing index by clinical examination 7th day comfort - will be assessed using comfort rating scale 1st, 2nd and 3rd day
Trial Locations
- Locations (1)
sibar institute of dental sciences
🇮🇳Guntur, ANDHRA PRADESH, India
sibar institute of dental sciences🇮🇳Guntur, ANDHRA PRADESH, IndiaAnand Vijay somuriPrincipal investigator7658900210dr.anandvijay@gmail.com