Periapical AbscessNCT07694531
"Is Antibiotic Therapy Necessary for Patients Undergoing Extraction of Teeth With Abscess?"
A study testing Amoxicillin 500mg in people with Periapical Abscess, run by Subbaiah Institute of Dental Sciences at 1 site in India.
Trial summary
This is a triple-blind randomized controlled trial conducted at the Department of Oral and Maxillofacial Surgery, Subbaiah Institute of Dental Sciences, Shimoga. The study enrolls 176 adult patients aged above 18 years belonging to ASA class 1 or 2, requiring intra-alveolar extraction of non-restorable carious teeth… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periapical Abscess
- What is being tested?
- Amoxicillin 500mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteIndia
- Study dates
- 20 Mar 2025to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged above 18 years
- Patients who are willing to participate in the study
- Patients requiring extraction of non-restorable carious teeth with radiographic evidence of periapical abscess (< 1.5cm diameter ill-defined, diffused periapical radiolucent lesion )
- Patients who come under ASA class 1 and 2 classification
Who cannot join
- Patients requiring trans-alveolar extraction
- Patients with known Penicillin allergy
- Pregnant women
- Patients undergoing antibiotic therapy perioperatively
- Patients not complying with follow-up
Trial locations and contacts
1 site in 1 country.
India1 site
Oral and Maxillofacial Surgery department in Subbaiah Institute of Dental Sciences
Shimoga, Karnataka, 577201
About this study
Official title: "Is Antibiotic Therapy Necessary for Patients Undergoing Extraction of Tooth With a Periapical Abscess? : A Randomised Controlled Clinical Study"
This is a triple-blind randomized controlled trial conducted at the Department of Oral and Maxillofacial Surgery, Subbaiah Institute of Dental Sciences, Shimoga. The study enrolls 176 adult patients aged above 18 years belonging to ASA class 1 or 2, requiring intra-alveolar extraction of non-restorable carious teeth with radiographic evidence of periapical abscess of less than 1.5 cm in diameter. Patients are randomly allocated into two equal groups of 88 each. Group A receives postoperative Amoxicillin 500 mg thrice daily for 5 days in addition to standard analgesics. Group B receives only standard analgesics with no antibiotic prescription. The primary outcome measure is wound healing assessed on postoperative day 5 using a modified Landry Wound Healing Index evaluating gingival tissue color, response to palpation, presence of granulation tissue, and suppuration.
- Conditions
- Periapical Abscess
- Being tested
- Amoxicillin 500mg
- Keywords
- Antibiotics, Periapical Abscess, Tooth Extraction, Wound Healing, Antibiotic Resistance, Randomized Controlled Trial
- Medical subject headings
- Periapical Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin 500mgDrug
A single operator performs intra-alveolar extraction under local anaesthesia using 2 per cent Lignocaine with Adrenaline 1 in 200000. The procedure involves detachment of gingival mucoperiosteum without incisions, forceps or elevator extraction without ostectomy, saline irrigation, manual compression of socket and placement of moist gauze pack for pressure. Postoperatively, Amoxicillin 500 mg is administered to patients in Group A, thrice daily after food for 5 days. Standard postoperative instructions are provided and patient is reviewed on the 5th postoperative day
| Study group | Role | What they receive |
|---|---|---|
| Arm 1(Group A): Extraction with postoperative antibiotics (Capsule Amoxicillin 500mg TID for 5 days) | Experimental | 88 patients undergoing intra-alveolar extraction of non-restorable carious teeth with radiographic evidence of periapical abscess receiving postoperative Amoxicillin 500 mg thrice daily after food for 5 days along with standard analgesics. Wound healing is assessed on the 5th postoperative day using a modified Landry Wound Healing Index. Receives: Drug: Amoxicillin 500mg |
| Arm 2 (Group B): Extraction without postoperative antibiotics | No intervention | 88 patients undergoing intra-alveolar extraction of non-restorable carious teeth with radiographic evidence of periapical abscess receiving only standard analgesics postoperatively with no antibiotic prescription. Wound healing is assessed on the 5th postoperative day using a modified Landry Wound Healing Index. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the Extraction Socket Healing of Both the Groups Using a Modified Landry's Wound Healing Index
On postoperative day 5, a blinded investigator assesses the socket using a modified Landry's Wound Healing Index. The primary outcomes include:
- Gingival Tissue Colour: Rated from "more than 50% red" to "all pink".
- Response to Palpation: Presence or absence of bleeding.
- Granulation Tissue: Presence or absence.
- Suppuration: Presence or absence.
Scores are assigned from 1 (Very Poor) to 5 (Excellent) based on these criteria. If a patient experiences pain before the follow-up, they are examined for dry socket and managed accordingly
Measured: postoperative 5th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start20 Mar 2025
- Primary completion5 Sep 2025
- Study completion10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Periapical AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a triple-blinded, parallel-group, randomized controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Subbaiah Institute of Dental Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suchith S Shetty, Subbaiah Institute of Dental Sciences
- Investigators
- Suchith S Shetty, Masters in Dental Surgery, Principal investigator, Subbaiah Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694531
- Sponsor's protocol ID
- IEC Ref. No. SIDS/IEC/0127
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 26 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Is Antibiotic Therapy Necessary for Patients Undergoing Extraction of Tooth With a Periapical Abscess? : A Randomised Controlled Clinical Study"
- ClinicalTrials.gov ID
- NCT07694531
- Acronym / sponsor ID
- IEC Ref. No. SIDS/IEC/0127
- Conditions
- Periapical Abscess
- Keywords
- Antibiotics, Periapical Abscess, Tooth Extraction, Wound Healing, Antibiotic Resistance, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Subbaiah Institute of Dental SciencesUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 10 Jul 2026 (actual)
- Results
- Posted 26 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a triple-blind randomized controlled trial conducted at the Department of Oral and Maxillofacial Surgery, Subbaiah Institute of Dental Sciences, Shimoga. The study enrolls 176 adult patients aged above 18 years belonging to ASA class 1 or 2, requiring intra-alveolar extraction of non-restorable carious teeth with radiographic evidence of periapical abscess of less than 1.5 cm in diameter. Patients are randomly allocated into two equal groups of 88 each. Group A receives postoperative Amoxicillin 500 mg thrice daily for 5 days in addition to standard analgesics. Group B receives only standard analgesics with no antibiotic prescription. The primary outcome measure is wound healing assessed on postoperative day 5 using a modified Landry Wound Healing Index evaluating gingival tissue color, response to palpation, presence of granulation tissue, and suppuration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- It is a triple-blinded, parallel-group, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Arm 1(Group A): Extraction with postoperative antibiotics (Capsule Amoxicillin 500mg TID for 5 days) | Experimental | Drug: Amoxicillin 500mg88 patients undergoing intra-alveolar extraction of non-restorable carious teeth with radiographic evidence of periapical abscess receiving postoperative Amoxicillin 500 mg thrice daily after food for 5 days along with standard analgesics. Wound healing is assessed on the 5th postoperative day using a modified Landry Wound Healing Index. |
| Arm 2 (Group B): Extraction without postoperative antibiotics | No intervention | –88 patients undergoing intra-alveolar extraction of non-restorable carious teeth with radiographic evidence of periapical abscess receiving only standard analgesics postoperatively with no antibiotic prescription. Wound healing is assessed on the 5th postoperative day using a modified Landry Wound Healing Index. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged above 18 years
- Patients who are willing to participate in the study
- Patients requiring extraction of non-restorable carious teeth with radiographic evidence of periapical abscess (< 1.5cm diameter ill-defined, diffused periapical radiolucent lesion )
- Patients who come under ASA class 1 and 2 classification
Key exclusion criteria (5 listed)
- Patients requiring trans-alveolar extraction
- Patients with known Penicillin allergy
- Pregnant women
- Patients undergoing antibiotic therapy perioperatively
- Patients not complying with follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxicillin 500mgA single operator performs intra-alveolar extraction under local anaesthesia using 2 per cent Lignocaine with Adrenaline 1 in 200000. The procedure involves detachment of gingival mucoperiosteum without incisions, forceps or elevator extraction without ostectomy, saline irrigation, manual compression of socket and placement of moist gauze pack for pressure. Postoperatively, Amoxicillin 500 mg is administered to patients in Group A, thrice daily after food for 5 days. Standard postoperative instructions are provided and patient is reviewed on the 5th postoperative day | Drug | Arm 1(Group A): Extraction with postoperative antibiotics (Capsule Amoxicillin 500mg TID for 5 days) |
Primary outcome
Assessment of the Extraction Socket Healing of Both the Groups Using a Modified Landry's Wound Healing Index
Time frame: postoperative 5th day
On postoperative day 5, a blinded investigator assesses the socket using a modified Landry's Wound Healing Index. The primary outcomes include: * Gingival Tissue Colour: Rated from "more than 50% red" to "all pink". * Response to Palpation: Presence or absence of bleeding. * Granulation Tissue: Presence or absence. * Suppuration: Presence or absence. Scores are assigned from 1 (Very Poor) to 5 (Excellent) based on these criteria. If a patient experiences pain before the follow-up, they are examined for dry socket and managed accordingly
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suchith S Shetty, Masters in Dental Surgery principal investigator
Subbaiah Institute of Dental Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amoxicillin 500mg in people with Periapical Abscess, run by Subbaiah Institute of Dental Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the Extraction Socket Healing of Both the Groups Using a Modified Landry's Wound Healing Index (time frame: postoperative 5th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.