Anesthesia, LocalPDLNCT03173898
PDL Anesthesia Versus Local Infiltration
A study testing PDL anesthesia versus local infiltration in people with Anesthesia, Local, run by University of Jordan.
Trial summary
The literature concerning the success and pain scores of PDL injection technique compared with other techniques remains controversial; whereas some studies found no significant difference in pain scores between local infiltration and PDL injection, other older studies found that pain during administration of PDL… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- PDL anesthesia versus local infiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 6 Jul 2015to 31 Jan 2016
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The inclusion criteria were: patients who were fit for surgery under LA (classified by the American Society of Anaesthesiologists (ASA) as ASA I-ASA III); patients exhibiting full understanding of given oral instructions; and bilateral symmetrical posterior maxillary permanent teeth referred for non-surgical extractions under LA.
Who cannot join
- Exclusion criteria were: the presence of acute dento-alveoalr infection; patients requiring conscious sedation or general anesthesia; patients unwilling to participate in the study; patients with ASA greater than III; patients on anti-inflammatory or recreational drugs; and patients requiring more than two additional injections in one or both sides for incomplete anesthesia.
About this study
Official title: Periodontal Ligament Injection Versus Routine Local Infiltration, for the Non-surgical Single Posterior Maxillary Permanent Tooth Extraction: Comparative Double Blinded Randomized Clinical Study
The literature concerning the success and pain scores of PDL injection technique compared with other techniques remains controversial; whereas some studies found no significant difference in pain scores between local infiltration and PDL injection, other older studies found that pain during administration of PDL injection was described by the majority of patients either as greater than local infiltration6, or as negligible or as a less painful injection compared with other injection techniques. The aim of this study was to evaluate the efficacy of and patients' subjective responses to the PDL injection technique as compared to the traditional infiltration injection, for the non-surgical extraction of one posterior maxillary permanent tooth.
Read the detailed description
Aim: The aim of this study was to evaluate the efficacy of and patients' subjective responses to the periodontal ligament (PDL) anesthetic injection as compared to the traditional infiltration injection, for the non-surgical extraction of one posterior maxillary permanent tooth. Methods: All patients scheduled for non-surgical symmetrical maxillary posterior permanent teeth extraction in the Department of Oral and Maxillofacial Surgery (OMFS) at the University of Jordan Hospital, Amman, Jordan, over a-seven-month period, were invited to participate in this prospective randomized double blinded, split mouth study. Every patient received the recommended volumes of 2% lidocaine with 1:100.000 epinephrine for PDL injection on the experimental side, and for local infiltration on the control side. A Visual Analogue Scale (VAS) and a Verbal Rating Scale (VRS) were used to describe the pain felt during injection and extraction, respectively. Statistical significance was based on probability values of <0.05 and measured using Chi-Square and Student-t tests, and Nonparametric Mann-Whitney and Kruskal-Wallis tests.
- Conditions
- Anesthesia, Local
- Being tested
- PDL anesthesia versus local infiltration
- Keywords
- PDL Injection; Infiltration; Anesthesia; Extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDL anesthesia versus local infiltrationProcedure or surgery
Every patient received the recommended volumes of 2% lidocaine with 1:100.000 epinephrine for PDL injection on the experimental side, and for local infiltration on the control side. A Visual Analogue Scale (VAS) was used to describe the pain felt during injection.
| Study group | Role | What they receive |
|---|---|---|
| primary periodontal ligament anesthesia | Experimental | PDL anesthesia versus local infiltration Receives: Procedure: PDL anesthesia versus local infiltration |
| local infiltration | Active comparator | PDL anesthesia versus local infiltration Receives: Procedure: PDL anesthesia versus local infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Visual Analogue Scale (VAS) scores for injections pain
The VAS composed of a 100-mm line and allowed the patient to score the pain experienced during injections as low moderate and high
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start6 Jul 2015
- Primary completion31 Jan 2016
- Study completion31 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a prospective randomized double blinded, split mouth study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad H Al-Shayyab, University of Jordan
- Investigators
- Mohammad H Al-Shayyab, Fellowship, Principal investigator, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173898
- Sponsor's protocol ID
- RF: 10/2015/15791
- Acronym
- PDL
- Status last verified
- May 2017
- First submitted
- 28 May 2017
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Ligament Injection Versus Routine Local Infiltration, for the Non-surgical Single Posterior Maxillary Permanent Tooth Extraction: Comparative Double Blinded Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT03173898
- Acronym / sponsor ID
- PDL / RF: 10/2015/15791
- Conditions
- Anesthesia, Local
- Keywords
- PDL Injection; Infiltration; Anesthesia; Extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 6 Jul 2015 (actual)
- Primary completion
- 31 Jan 2016 (actual)
- Study completion
- 31 Jan 2016 (actual)
- First posted
- 2 Jun 2017 (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.
The literature concerning the success and pain scores of PDL injection technique compared with other techniques remains controversial; whereas some studies found no significant difference in pain scores between local infiltration and PDL injection, other older studies found that pain during administration of PDL injection was described by the majority of patients either as greater than local infiltration6, or as negligible or as a less painful injection compared with other injection techniques. The aim of this study was to evaluate the efficacy of and patients' subjective responses to the PDL injection technique as compared to the traditional infiltration injection, for the non-surgical extraction of one posterior maxillary permanent tooth.
Detailed description
Aim: The aim of this study was to evaluate the efficacy of and patients' subjective responses to the periodontal ligament (PDL) anesthetic injection as compared to the traditional infiltration injection, for the non-surgical extraction of one posterior maxillary permanent tooth. Methods: All patients scheduled for non-surgical symmetrical maxillary posterior permanent teeth extraction in the Department of Oral and Maxillofacial Surgery (OMFS) at the University of Jordan Hospital, Amman, Jordan, over a-seven-month period, were invited to participate in this prospective randomized double blinded, split mouth study. Every patient received the recommended volumes of 2% lidocaine with 1:100.000 epinephrine for PDL injection on the experimental side, and for local infiltration on the control side. A Visual Analogue Scale (VAS) and a Verbal Rating Scale (VRS) were used to describe the pain felt during injection and extraction, respectively. Statistical significance was based on probability values of <0.05 and measured using Chi-Square and Student-t tests, and Nonparametric Mann-Whitney and Kruskal-Wallis tests.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- a prospective randomized double blinded, split mouth study
| Arm | Type | Receives |
|---|---|---|
| primary periodontal ligament anesthesia | Experimental | Procedure: PDL anesthesia versus local infiltrationPDL anesthesia versus local infiltration |
| local infiltration | Active comparator | Procedure: PDL anesthesia versus local infiltrationPDL anesthesia versus local infiltration |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria were: patients who were fit for surgery under LA (classified by the American Society of Anaesthesiologists (ASA) as ASA I-ASA III); patients exhibiting full understanding of given oral instructions; and bilateral symmetrical posterior maxillary permanent teeth referred for non-surgical extractions under LA.
Key exclusion criteria (1 listed)
- Exclusion criteria were: the presence of acute dento-alveoalr infection; patients requiring conscious sedation or general anesthesia; patients unwilling to participate in the study; patients with ASA greater than III; patients on anti-inflammatory or recreational drugs; and patients requiring more than two additional injections in one or both sides for incomplete anesthesia.
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 |
|---|---|---|
| PDL anesthesia versus local infiltrationEvery patient received the recommended volumes of 2% lidocaine with 1:100.000 epinephrine for PDL injection on the experimental side, and for local infiltration on the control side. A Visual Analogue Scale (VAS) was used to describe the pain felt during injection. | Procedure or surgery | local infiltration, primary periodontal ligament anesthesia |
Primary outcome
the Visual Analogue Scale (VAS) scores for injections pain
Time frame: 5 minutes
The VAS composed of a 100-mm line and allowed the patient to score the pain experienced during injections as low moderate and high
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 5 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
Mohammad H Al-Shayyab, Fellowship principal investigator
University of Jordan
Questions about this trial
What is this clinical trial studying?
A study testing PDL anesthesia versus local infiltration in people with Anesthesia, Local, run by University of Jordan.
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 1 inclusion and 1 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 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
the Visual Analogue Scale (VAS) scores for injections pain (time frame: 5 minutes). 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 5 Jun 2017.