Inflamed and Infected Primary Molars in ChildrenNCT07120594
Evaluate Buffering Local Anesthetic in Inflamed Teeth
A study testing Unbuffered lidocaine 2% with epinephrine 1:80,000 and Buffered lidocaine 2% with epinephrine 1:80,000 in people with Inflamed and Infected Primary Molars in Children and Effectiveness of Buffered Local Anesthesia During Dental Extraction, run by Latakia University at 1 site in Syria.
Trial summary
This randomized, double-blinded, split-mouth clinical trial evaluates the effect of buffering local anesthetic with sodium bicarbonate in pediatric dental extractions. Twenty children aged 6 to 10 years with two infected primary molars on opposite sides of the maxilla participated. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Inflamed and Infected Primary Molars in Children, Effectiveness of Buffered Local Anesthesia During Dental Extraction
- What is being tested?
- Unbuffered lidocaine 2% with epinephrine 1:80,000 and Buffered lidocaine 2% with epinephrine 1:80,000
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSyria
- Study dates
- 8 Nov 2023to 20 Jul 2025
- Phase
- Interventional
- 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6 to 10 years with bilateral maxillary first or second primary molars indicated for extraction due to infection and inflammation.
- Presence of clinical signs of inflammation (e.g., redness, swelling) in the gingiva surrounding the affected teeth.
- Medically healthy children with no systemic diseases or cognitive disabilities.
- Children with positive or definitely positive behavior according to the Frankl Behavior Rating Scale.
- No intake of medications that may interfere with pain perception during the 24 hours preceding the treatment session.
Who cannot join
- Presence of systemic medical conditions.
- Children with negative or definitely negative behavior according to the Frankl Behavior Rating Scale.
- Known allergy to the local anesthetic agent.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Pediatric Dentistry, Faculty of Dentistry, Tishreen University
Latakia, Latakia Governorate
About this study
Official title: Evaluate the Effectiveness of Buffering Local Anesthetic With Sodium Bicarbonate in Infected and Inflamed Teeth in Children
This randomized, double-blinded, split-mouth clinical trial evaluates the effect of buffering local anesthetic with sodium bicarbonate in pediatric dental extractions. Twenty children aged 6 to 10 years with two infected primary molars on opposite sides of the maxilla participated. Each child received standard anesthetic on one side and buffered anesthetic on the other. Pain levels and onset time were measured to assess anesthetic efficacy.
Read the detailed description
This randomized, controlled, double-blinded, split-mouth clinical trial aims to evaluate the efficacy of buffering local anesthetic solution with sodium bicarbonate in the extraction of infected and inflamed primary molars in children. Infected tissues tend to have a lower PH , which can limit the effectiveness of local anesthetics by reducing the proportion of the active, non-ionized drug form. buffering with sodium bicarbonate improve anesthetic performance by raising the pH of the solution, enhancing its diffusion and clinical effectiveness.
The study included 20 healthy children aged 6 to 10 years, each with two infected or inflamed primary molars located on opposite sides of the maxilla. A split-mouth design was employed, where each child received a standard local anesthetic solution - lidocaine 2% with epinephrine 1:80,000 - on one side, and a buffered solution (alkalinized with sodium bicarbonate) on the contralateral side.
To assess anesthetic efficacy, three parameters were measured: pulse rate (as a physiologic indicator of pain), the Sound-Eye-Motor (SEM) scale (for behavioral response), and the Wong-Baker Faces Pain Rating Scale (for subjective pain reporting). Onset time of anesthesia was also recorded.
The study aims to determine whether buffering lidocaine with sodium bicarbonate improves pain control and onset time during pediatric dental extractions in inflamed and infected tissues.
- Conditions
- Inflamed and Infected Primary Molars in Children, Effectiveness of Buffered Local Anesthesia During Dental Extraction
- Being tested
- Unbuffered lidocaine 2% with epinephrine 1:80,000, Buffered lidocaine 2% with epinephrine 1:80,000
- Keywords
- Buffered local anesthesia, Sodium bicarbonate, Pain during injection, Pediatric dentistry, Tooth extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unbuffered lidocaine 2% with epinephrine 1:80,000Drug
Standard local anesthetic solution without pH modification. Used for maxillary extraction of infected primary molars in pediatric patients.
Buffered lidocaine 2% with epinephrine 1:80,000Drug
Local anesthetic solution mixed with sodium bicarbonate to increase pH before injection. Used for maxillary extraction of infected primary molars in pediatric patients.
| Study group | Role | What they receive |
|---|---|---|
| Standard Local Anesthetic | Active comparator | Participants receive the standard local anesthetic solution-lidocaine 2% with epinephrine 1:80,000-for extraction of infected and inflamed primary molars. Receives: Drug: Unbuffered lidocaine 2% with epinephrine 1:80,000 |
| Buffered Local Anesthetic | Experimental | Participants receive a buffered local anesthetic solution-lidocaine 2% with epinephrine 1:80,000 buffering with sodium bicarbonate-to assess enhanced anesthetic efficacy during extraction of infected and inflamed primary molars. Receives: Drug: Buffered lidocaine 2% with epinephrine 1:80,000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level during tooth extraction in inflamed sites (self-reported)
Procedural pain during extraction was assessed using the Wong-Baker FACES Pain Rating Scale to measure children's self-reported pain. This scale uses six cartoon faces representing increasing levels of pain, scored from 0 (no pain) to 10 (worst pain). Children were asked to indicate the face that best matched their pain level during tooth extraction in inflamed areas. Higher scores indicate greater pain intensity.
Measured: During the tooth extraction procedure
Pain-related behavioral response during extraction in inflamed primary molars (observer-rated)
Procedural pain behavior will be assessed using the Sound-Eye-Motor (SEM) scale. Trained observers will score behavioral responses during extraction; higher scores indicate stronger pain-related behavior.
Measured: During the tooth extraction procedure
Physiological response during extraction in inflamed primary molars (heart rate)
Heart rate (beats per minute) will be continuously monitored with a pulse oximeter. Increases from baseline are considered indicators of pain/stress during extraction.
Measured: through the extraction procedure
Secondary outcomes (3)
Pain perception during injection of anesthetic solution (self-reported)
Pain during injection will be self-reported using the Wong-Baker FACES Pain Rating Scale. Children indicate the face that best matches injection pain (0-10)
Measured: During and within 1 minute after anesthetic injection
Behavioral response during anesthetic injection (SEM)
Observer-rated SEM scores will be recorded during anesthetic injection to evaluate behavioral response to injection pain
Measured: During and within 1 minute after anesthetic injection
Physiological response to injection (heart rate)
Heart rate (beats per minute) will be recorded before, during, and immediately after injection. Changes from baseline will be used as an objective marker of pain/stress
Measured: During anesthetic injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start8 Nov 2023
- Primary completion20 Jul 2025
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflamed and Infected Primary Molars in ChildrenStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120594
- Sponsor's protocol ID
- TishreenU Pedodontic
- Status last verified
- Oct 2023
- First submitted
- 24 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Effectiveness of Buffering Local Anesthetic With Sodium Bicarbonate in Infected and Inflamed Teeth in Children
- ClinicalTrials.gov ID
- NCT07120594
- Acronym / sponsor ID
- TishreenU Pedodontic
- Conditions
- Inflamed and Infected Primary Molars in Children, Effectiveness of Buffered Local Anesthesia During Dental Extraction
- Keywords
- Buffered local anesthesia, Sodium bicarbonate, Pain during injection, Pediatric dentistry, Tooth extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 20 Jul 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 13 Aug 2025 (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.
This randomized, double-blinded, split-mouth clinical trial evaluates the effect of buffering local anesthetic with sodium bicarbonate in pediatric dental extractions. Twenty children aged 6 to 10 years with two infected primary molars on opposite sides of the maxilla participated. Each child received standard anesthetic on one side and buffered anesthetic on the other. Pain levels and onset time were measured to assess anesthetic efficacy.
Detailed description
This randomized, controlled, double-blinded, split-mouth clinical trial aims to evaluate the efficacy of buffering local anesthetic solution with sodium bicarbonate in the extraction of infected and inflamed primary molars in children. Infected tissues tend to have a lower PH , which can limit the effectiveness of local anesthetics by reducing the proportion of the active, non-ionized drug form. buffering with sodium bicarbonate improve anesthetic performance by raising the pH of the solution, enhancing its diffusion and clinical effectiveness.
The study included 20 healthy children aged 6 to 10 years, each with two infected or inflamed primary molars located on opposite sides of the maxilla. A split-mouth design was employed, where each child received a standard local anesthetic solution - lidocaine 2% with epinephrine 1:80,000 - on one side, and a buffered solution (alkalinized with sodium bicarbonate) on the contralateral side.
To assess anesthetic efficacy, three parameters were measured: pulse rate (as a physiologic indicator of pain), the Sound-Eye-Motor (SEM) scale (for behavioral response), and the Wong-Baker Faces Pain Rating Scale (for subjective pain reporting). Onset time of anesthesia was also recorded.
The study aims to determine whether buffering lidocaine with sodium bicarbonate improves pain control and onset time during pediatric dental extractions in inflamed and infected tissues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Local Anesthetic | Active comparator | Drug: Unbuffered lidocaine 2% with epinephrine 1:80,000Participants receive the standard local anesthetic solution-lidocaine 2% with epinephrine 1:80,000-for extraction of infected and inflamed primary molars. |
| Buffered Local Anesthetic | Experimental | Drug: Buffered lidocaine 2% with epinephrine 1:80,000Participants receive a buffered local anesthetic solution-lidocaine 2% with epinephrine 1:80,000 buffering with sodium bicarbonate-to assess enhanced anesthetic efficacy during extraction of infected and inflamed primary molars. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 6 to 10 years with bilateral maxillary first or second primary molars indicated for extraction due to infection and inflammation.
- Presence of clinical signs of inflammation (e.g., redness, swelling) in the gingiva surrounding the affected teeth.
- Medically healthy children with no systemic diseases or cognitive disabilities.
- Children with positive or definitely positive behavior according to the Frankl Behavior Rating Scale.
- No intake of medications that may interfere with pain perception during the 24 hours preceding the treatment session.
Key exclusion criteria (3 listed)
- Presence of systemic medical conditions.
- Children with negative or definitely negative behavior according to the Frankl Behavior Rating Scale.
- Known allergy to the local anesthetic agent.
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 |
|---|---|---|
| Unbuffered lidocaine 2% with epinephrine 1:80,000Standard local anesthetic solution without pH modification. Used for maxillary extraction of infected primary molars in pediatric patients. | Drug | Standard Local Anesthetic |
| Buffered lidocaine 2% with epinephrine 1:80,000Local anesthetic solution mixed with sodium bicarbonate to increase pH before injection. Used for maxillary extraction of infected primary molars in pediatric patients. | Drug | Buffered Local Anesthetic |
Primary outcome
Pain level during tooth extraction in inflamed sites (self-reported)
Time frame: During the tooth extraction procedure
Procedural pain during extraction was assessed using the Wong-Baker FACES Pain Rating Scale to measure children's self-reported pain. This scale uses six cartoon faces representing increasing levels of pain, scored from 0 (no pain) to 10 (worst pain). Children were asked to indicate the face that best matched their pain level during tooth extraction in inflamed areas. Higher scores indicate greater pain intensity.
Pain-related behavioral response during extraction in inflamed primary molars (observer-rated)
Time frame: During the tooth extraction procedure
Procedural pain behavior will be assessed using the Sound-Eye-Motor (SEM) scale. Trained observers will score behavioral responses during extraction; higher scores indicate stronger pain-related behavior.
Physiological response during extraction in inflamed primary molars (heart rate)
Time frame: through the extraction procedure
Heart rate (beats per minute) will be continuously monitored with a pulse oximeter. Increases from baseline are considered indicators of pain/stress during extraction.
3 secondary outcomes
Pain perception during injection of anesthetic solution (self-reported)
Time frame: During and within 1 minute after anesthetic injection
Behavioral response during anesthetic injection (SEM)
Time frame: During and within 1 minute after anesthetic injection
Physiological response to injection (heart rate)
Time frame: During anesthetic injection
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 13 Aug 2025.
- Individual participant dataSharing planned: No
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 study testing Unbuffered lidocaine 2% with epinephrine 1:80,000 and Buffered lidocaine 2% with epinephrine 1:80,000 in people with Inflamed and Infected Primary Molars in Children and Effectiveness of Buffered Local Anesthesia During Dental Extraction, run by Latakia University at 1 site in Syria.
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 5 inclusion and 3 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 13 Aug 2025. 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 Syria. 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?
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?
Pain level during tooth extraction in inflamed sites (self-reported) (time frame: During the tooth extraction procedure). The study lists 3 primary outcomes in all. 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 13 Aug 2025; AzTrials last refreshed its copy on 1 Nov 2026.