Dry SocketPhase 2NCT03992144
Prevention of Dry Socket by Means of Single Preoperative Antibiotics Compared to Conventional Therapy
A Phase 2 study testing Amoxicillin 500 Mg, metronidazole 400mg and metronidazol 400mg and amoxicillin 500mg in people with Dry Socket, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
Background: One of the commonest post-operative complications after tooth extraction is dry socket; it can be defined as postoperative pain in and around the tooth extraction site, which increases in severity at any time between 3rd to 5th post-operative days along with disintegrated blood clot within the tooth… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Socket
- What is being tested?
- Amoxicillin 500 Mg, metronidazole 400mg and metronidazol 400mg and amoxicillin 500mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2018to 15 Apr 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients requiring surgical extraction of lower third molars with class 2 impaction.
- Males and females were included.
- Age range of the patients was between 18 to 40 years.
Who cannot join
- Non-surgical extractions, extractions of other then lower molars,
- Infected tooth.
- tooth with grade 3 or greater mobility.
- Reluctant to participate.
- Pregnant ladies.
- Nursing mothers.
Show all 13Show fewer
- Alcoholic patients.
- Smokers.
- Patients taking oral contraceptives.
- Patient already taking antibiotics.
- Allergic to amoxicillin and metronidazole.
- Patients on anticoagulant therapy i.e. warfarin, nicoumalone, phenytoin, fluocil.
- Those with severe renal and hepatic dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Prevention of Dry Socket by Means of Single Preoperative Oral Dose of Metronidazole and Amoxicillin Compared to Conventional Therapy"
Background: One of the commonest post-operative complications after tooth extraction is dry socket; it can be defined as postoperative pain in and around the tooth extraction site, which increases in severity at any time between 3rd to 5th post-operative days along with disintegrated blood clot within the tooth extraction socket with or without halitosis. The exact etiology is unclear therefor prevention remains the main beneficial therapy. Various factors are thought to play an important role in etiology of dry socket including, anaerobes, fibrinolysis, traumatic extractions, frequent spiting and rinsing, oral contraceptive pill and smoking.
Numerous approaches have been tried for prevention of dry socket; include antiseptic mouthwashes, anti-fibrinolytic agents, antibiotics, intra-socket dressings and medicated packing into the extraction wound for example chlorohexidine mouthwashes, warm saline rinses, gelatin sponges, occlusive dressings and oxidized cellulose sponge.
Read more
Purpose of the study is to compare the role of single preoperative oral dose of metronidazole with amoxicillin in hindrance of dry socket compared to conventional therapy after removal of mandibular third molar of class 2 impaction.
Objectives: To find out effective treatment for prevention of dry socket among preoperative single oral dose of metronidazole and amoxicillin compared to conventional therapy.
Methods: A double blind randomized control trial in which patients requiring surgical extraction of lower 3rd molar of class 2 impactions were selected for this study. Patients were randomly divided into 3 groups, one of the groups had received single preoperative oral dose of metronidazole one hour before extraction, second group was treated with single oral dose of amoxicillin an hour before tooth extraction and third group was treated with conventional therapy. Patients were asked to visit on 5th postoperative day or before it in case the pain persist or reoccur.
Read the detailed description
Background Dry socket is one of the commonest problems that occur after extraction of molars. It can be described as a painful inflammatory condition that occurs due to non-formation or early displacement of a blood clot from a tooth extraction site before the healing of wound occurs. Clinical presentation of dry socket is intense ache, bad breath, hollow socket due to displacement of blood clot and exposure of bone. Pain produced by dry socket is known to last from 7 to 14 days. Incidence of dry socket is approximately 3% for routine extractions and can go beyond 30% for impacted lower third molars.
Tooth impaction is a pathological condition in which a tooth fails to erupt to the occlusal level of its normal position. Lower third molars are the most commonly impacted teeth. The prevalence of third molar impaction ranges from 16.7% to 68.6%.
Multiple factors are associated with dry socket formation. such as patient's age, Gender, extraction in posterior region of mouth, smoking status, oral contraceptive.
Incidence of dry socket perhaps lies somewhere from 5% to 20% worldwide.It ranges broadly between 0.9% and 21% in United Kingdom and 3.5% in Siri-Lankan. Incidence of dry socket in Pakistani population is reported 13.8%20.
Incidence of dry socket after extraction of impacted third molars is about 25-30%33.
Third molar is the most frequently impacted tooth and its prevalence ranges from 16.7% to 68.6%.
Methods Data collection was done from the patients requiring surgical extraction of mandibular third molars class two impaction, at outpatient department of oral and maxillofacial department of Dow university health sciences.
Patients were selected according to the inclusion and exclusion criteria. After explaining the purpose of the study and its associated benefits and risks, consent was obtained from the patients. Patients were randomly divided into 3 groups. Ethical approval was obtained from institutional review board of DUHS, Karachi.
Lower 3rd molars with class 2 impaction, both genders, aged between 18 to 40 years were included in the trail. Whereas smokers, alcoholic patients, pregnant and nursing mothers, those taking anticoagulant, oral contraceptives, already taking antibiotics, with renal or hepatic dysfunction, allergic to antibiotics and reluctant to participate were excluded from the trail.
All of the patients were operated by R2 postgraduate trainee of oral and maxillofacial surgery department, under local anesthesia, inferior alveolar and long buccal nerves were anesthetized. Incision was given, flap was elevated and osteotomy and/or tooth section was done depending on the case. Round and fissured burs were used to remove the bone with low speed micrometer straight hand piece. Normal saline was used as coolant and irrigating solution. After extraction of the tooth, socket was irrigated and flushed with normal saline. Sutures were given with 3-0 silk material and a roll of sanitized gauze was placed over the extraction socket and patients were asked to bite on it for at least 40 minutes. prescribed. Post-operative instructions were given to the patients both verbally as well as in written form. On fifth post-operative day patients were examined with naked eye under the light of dental unite. Those diagnosed with dry socket were treated with alveogel after irrigating and flushing the socket with normal saline.
- Conditions
- Dry Socket
- Being tested
- Amoxicillin 500 Mg, metronidazole 400mg, metronidazol 400mg and amoxicillin 500mg
- Keywords
- dry socket, metronidazole, amoxicillin, lower 3rd molars
- Medical subject headings
- Dry Socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin 500 MgDrug
Also called amoxill 500mg
Amoxicillin 500mg an hour before tooth extraction
metronidazole 400mgDrug
Also called flygel 400mg
400mg of metronidazole an hour before extraction
metronidazol 400mg and amoxicillin 500mgDrug
400mg metronidazole TDS, amoxicillin 500mg BD for 5 days after extraction
| Study group | Role | What they receive |
|---|---|---|
| amoxicillin | Experimental | single preoperative oral 500 mg dose of Amoxicillin before extraction of lower 3rd molar and painkillers after extraction for 1st 48 hours then sos. Receives: Drug: Amoxicillin 500 Mg |
| metronidazole | Experimental | single preoperative oral 400 mg dose of metronidazol before extraction of lower 3rd molar and painkillers after extraction for 1st 48 hours then sos. Receives: Drug: metronidazole 400mg |
| conventional group | Active comparator | conventional therapy for prevention of dry socket post operative; 400mg metrinidazol 3 times a day for 5 days 500mg of amooxicillin 2 times a day for 5 days painkiller 48 hours after extraction then sos Receives: Drug: metronidazol 400mg and amoxicillin 500mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
dry socket
Characteristic of interest: patient complaining of moderate to severe pain in or around the tooth extraction site between 3 to 5 post-operative days.
Measuring instruments: The observation will be performed with naked eye under the light of dental unit and cheek will be retracted via dental mirror instrument.
Method of testing: Presence of moderate to severe pain, total or incomplete loss of blood clot, bare bone in the socket, and halitosis.
Decision criteria: Presence of above features at the site of tooth extraction will indicate the presence of dry socket.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start1 Oct 2018
- Primary completion31 Jan 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry SocketStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tahseen Shabbir Khooharo, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992144
- Sponsor's protocol ID
- Tahseen.S.Khooharo
- Status last verified
- Jun 2019
- First submitted
- 13 Jun 2019
- Last updated
- 20 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Prevention of Dry Socket by Means of Single Preoperative Oral Dose of Metronidazole and Amoxicillin Compared to Conventional Therapy"
- ClinicalTrials.gov ID
- NCT03992144
- Acronym / sponsor ID
- Tahseen.S.Khooharo
- Conditions
- Dry Socket
- Keywords
- dry socket, metronidazole, amoxicillin, lower 3rd molars
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: One of the commonest post-operative complications after tooth extraction is dry socket; it can be defined as postoperative pain in and around the tooth extraction site, which increases in severity at any time between 3rd to 5th post-operative days along with disintegrated blood clot within the tooth extraction socket with or without halitosis. The exact etiology is unclear therefor prevention remains the main beneficial therapy. Various factors are thought to play an important role in etiology of dry socket including, anaerobes, fibrinolysis, traumatic extractions, frequent spiting and rinsing, oral contraceptive pill and smoking.
Numerous approaches have been tried for prevention of dry socket; include antiseptic mouthwashes, anti-fibrinolytic agents, antibiotics, intra-socket dressings and medicated packing into the extraction wound for example chlorohexidine mouthwashes, warm saline rinses, gelatin sponges, occlusive dressings and oxidized cellulose sponge.
Purpose of the study is to compare the role of single preoperative oral dose of metronidazole with amoxicillin in hindrance of dry socket compared to conventional therapy after removal of mandibular third molar of class 2 impaction.
Objectives: To find out effective treatment for prevention of dry socket among preoperative single oral dose of metronidazole and amoxicillin compared to conventional therapy.
Methods: A double blind randomized control trial in which patients requiring surgical extraction of lower 3rd molar of class 2 impactions were selected for this study. Patients were randomly divided into 3 groups, one of the groups had received single preoperative oral dose of metronidazole one hour before extraction, second group was treated with single oral dose of amoxicillin an hour before tooth extraction and third group was treated with conventional therapy. Patients were asked to visit on 5th postoperative day or before it in case the pain persist or reoccur.
Detailed description
Background Dry socket is one of the commonest problems that occur after extraction of molars. It can be described as a painful inflammatory condition that occurs due to non-formation or early displacement of a blood clot from a tooth extraction site before the healing of wound occurs. Clinical presentation of dry socket is intense ache, bad breath, hollow socket due to displacement of blood clot and exposure of bone. Pain produced by dry socket is known to last from 7 to 14 days. Incidence of dry socket is approximately 3% for routine extractions and can go beyond 30% for impacted lower third molars.
Tooth impaction is a pathological condition in which a tooth fails to erupt to the occlusal level of its normal position. Lower third molars are the most commonly impacted teeth. The prevalence of third molar impaction ranges from 16.7% to 68.6%.
Multiple factors are associated with dry socket formation. such as patient's age, Gender, extraction in posterior region of mouth, smoking status, oral contraceptive.
Incidence of dry socket perhaps lies somewhere from 5% to 20% worldwide.It ranges broadly between 0.9% and 21% in United Kingdom and 3.5% in Siri-Lankan. Incidence of dry socket in Pakistani population is reported 13.8%20.
Incidence of dry socket after extraction of impacted third molars is about 25-30%33.
Third molar is the most frequently impacted tooth and its prevalence ranges from 16.7% to 68.6%.
Methods Data collection was done from the patients requiring surgical extraction of mandibular third molars class two impaction, at outpatient department of oral and maxillofacial department of Dow university health sciences.
Patients were selected according to the inclusion and exclusion criteria. After explaining the purpose of the study and its associated benefits and risks, consent was obtained from the patients. Patients were randomly divided into 3 groups. Ethical approval was obtained from institutional review board of DUHS, Karachi.
Lower 3rd molars with class 2 impaction, both genders, aged between 18 to 40 years were included in the trail. Whereas smokers, alcoholic patients, pregnant and nursing mothers, those taking anticoagulant, oral contraceptives, already taking antibiotics, with renal or hepatic dysfunction, allergic to antibiotics and reluctant to participate were excluded from the trail.
All of the patients were operated by R2 postgraduate trainee of oral and maxillofacial surgery department, under local anesthesia, inferior alveolar and long buccal nerves were anesthetized. Incision was given, flap was elevated and osteotomy and/or tooth section was done depending on the case. Round and fissured burs were used to remove the bone with low speed micrometer straight hand piece. Normal saline was used as coolant and irrigating solution. After extraction of the tooth, socket was irrigated and flushed with normal saline. Sutures were given with 3-0 silk material and a roll of sanitized gauze was placed over the extraction socket and patients were asked to bite on it for at least 40 minutes. prescribed. Post-operative instructions were given to the patients both verbally as well as in written form. On fifth post-operative day patients were examined with naked eye under the light of dental unite. Those diagnosed with dry socket were treated with alveogel after irrigating and flushing the socket with normal saline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| amoxicillin | Experimental | Drug: Amoxicillin 500 Mgsingle preoperative oral 500 mg dose of Amoxicillin before extraction of lower 3rd molar and painkillers after extraction for 1st 48 hours then sos. |
| metronidazole | Experimental | Drug: metronidazole 400mgsingle preoperative oral 400 mg dose of metronidazol before extraction of lower 3rd molar and painkillers after extraction for 1st 48 hours then sos. |
| conventional group | Active comparator | Drug: metronidazol 400mg and amoxicillin 500mgconventional therapy for prevention of dry socket post operative; 400mg metrinidazol 3 times a day for 5 days 500mg of amooxicillin 2 times a day for 5 days painkiller 48 hours after extraction then sos |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients requiring surgical extraction of lower third molars with class 2 impaction.
- Males and females were included.
- Age range of the patients was between 18 to 40 years.
Key exclusion criteria (13 listed)
- Non-surgical extractions, extractions of other then lower molars,
- Infected tooth.
- tooth with grade 3 or greater mobility.
- Reluctant to participate.
- Pregnant ladies.
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 500 MgAlso: amoxill 500mgAmoxicillin 500mg an hour before tooth extraction | Drug | amoxicillin |
| metronidazole 400mgAlso: flygel 400mg400mg of metronidazole an hour before extraction | Drug | metronidazole |
| metronidazol 400mg and amoxicillin 500mg400mg metronidazole TDS, amoxicillin 500mg BD for 5 days after extraction | Drug | conventional group |
Primary outcome
dry socket
Time frame: 5 days
Characteristic of interest: patient complaining of moderate to severe pain in or around the tooth extraction site between 3 to 5 post-operative days. Measuring instruments: The observation will be performed with naked eye under the light of dental unit and cheek will be retracted via dental mirror instrument. Method of testing: Presence of moderate to severe pain, total or incomplete loss of blood clot, bare bone in the socket, and halitosis. Decision criteria: Presence of above features at the site of tooth extraction will indicate the presence of dry socket.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amoxicillin 500 Mg, metronidazole 400mg and metronidazol 400mg and amoxicillin 500mg in people with Dry Socket, run by Dow University of Health Sciences at 1 site in Pakistan.
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 3 inclusion and 13 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 20 Jun 2019. 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 Pakistan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
dry socket (time frame: 5 days). 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 20 Jun 2019.