Dental FearPhase 4NCT02619981
The Effect of Parental Presence on Dental Fear
A Phase 4 study testing Restorative procedure and Maxillary infiltration anesthesia with 2%Lidocaine in people with Dental Fear, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
Trial summary
150 children aged between five and seven years presenting for the first dental visit, whose parents consented to participate in the study were selected from patients reporting to the dental clinics Riyadh Colleges of Dentistry and Pharmacy using convenience sampling. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Fear
- What is being tested?
- Restorative procedure and Maxillary infiltration anesthesia with 2%Lidocaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Nov 2012to Feb 2015
- Phase
- Phase 4
- 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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- No previous restorative dental experience
- At least one maxillary posterior tooth requiring restorative care
- Parental consent to participate in the study
Who cannot join
- Children with previous restorative dental experience
- Children with intellectual disability
- Children with diagnosed neurobehavioral disorders, including (but not limited to ), Autism spectrum disorders, learning disabilities, cerebral palsy, attention deficit hyperactivity disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Objective Assessment of Dental Fear, and the Influence of the Parental Presence on the Behavior of Anxious Children on Their First Restorative Dental Visit
150 children aged between five and seven years presenting for the first dental visit, whose parents consented to participate in the study were selected from patients reporting to the dental clinics Riyadh Colleges of Dentistry and Pharmacy using convenience sampling. Pulse rate for each patient was measured at different clinical situation starting from patient parent separation until end of appointment using a pulse oximeter, Data which collected was statistically analyzed using appropriate statistical analyses using SPSS ver.19 data processing software.
Read the detailed description
150 children aged between five and seven years presenting for the first dental visit, whose parents consented to participate in the study were selected from patients reporting to the dental clinics Riyadh Colleges of Dentistry and Pharmacy using convenience sampling. Only children who were classified as anxious but able to cope were included in the study (Rating 2 on the Venham's scale).
Pulse rate for each patient was measured at six different clinical situations. 1) Baseline 2) Seating of the child at the chair, 3) Arrival of the dentist, 4) Administration of local anesthesia 5) During the procedure, 6) End of Appointment.
Based on the accompanying person the children were classified as children accompanied by mothers alone, children accompanied by fathers alone, children accompanied by both parents.
The behavior of the child at each situation was recorded using the modified Venham's scale at each interval. The heart rate and oxygen saturation were recorded using pulse oxymetry
- Conditions
- Dental Fear
- Being tested
- Restorative procedure, Maxillary infiltration anesthesia with 2%Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restorative procedureProcedure or surgery
Also called Dental Filling
A restorative dental procedure requiring maxillary buccal infiltration anesthesia, and not exceeding 30 minutes of working time
Maxillary infiltration anesthesia with 2%LidocaineDrug
Also called 2% Lignociane
1.8ml of 2% Lidocaine with adrenaline administered using a 27 gauge 21mm needle
| Study group | Role | What they receive |
|---|---|---|
| Father present | Active comparator | Child seated at the dental chair, buccal maxillary infiltration anesthesia with 2%Lidocaine administered using a 27 gauge 21mm needle , restorative procedure completed , Father present Receives: Procedure: Restorative procedure; Drug: Maxillary infiltration anesthesia with 2%Lidocaine |
| Mother Present | Active comparator | Child seated at the dental chair, buccal maxillary infiltration anesthesia with 2%Lidocaine administered using a 27 gauge 21mm needle , restorative procedure completed , Mother present Receives: Procedure: Restorative procedure; Drug: Maxillary infiltration anesthesia with 2%Lidocaine |
| Both parents present | Active comparator | Child seated at the dental chair, buccal maxillary infiltration anesthesia with 2%Lidocaine administered using a 27 gauge 21mm needle , restorative procedure completed , both parents present Receives: Procedure: Restorative procedure; Drug: Maxillary infiltration anesthesia with 2%Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child behavior - Subjective
Child behavior monitored using the Venham scale
Measured: 30min
Secondary outcomes (1)
Child Behavior - Objective
Child Behavior Monitored using Pulse oximeter
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startNov 2012
- Primary completionNov 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental FearStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riyadh Colleges of Dentistry and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sharat Pani, Riyadh Colleges of Dentistry and Pharmacy
- Investigators
- Hezekiah Mosadomi, DMD, Study director, Riyadh Colleges of Dentistry and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619981
- Sponsor's protocol ID
- IRP/2012/48
- Status last verified
- Nov 2015
- First submitted
- 27 Nov 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Cox IC, Krikken JB, Veerkamp JS. Influence of parental presence on the child's perception of, and behaviour, during dental treatment. Eur Arch Paediatr Dent. 2011 Aug;12(4):200-4. doi: 10.1007/BF03262807.
PubMed 21806904Afshar H, Baradaran Nakhjavani Y, Mahmoudi-Gharaei J, Paryab M, Zadhoosh S. The Effect of Parental Presence on the 5 year-Old Children's Anxiety and Cooperative Behavior in the First and Second Dental Visit. Iran J Pediatr. 2011 Jun;21(2):193-200.
PubMed 23056787Al-Shalan TA, Al-Musa BA, Al-Khamis AM. Parents' attitude towards children's first dental visit in the College of Dentistry, Riyadh, Saudi Arabia. Saudi Med J. 2002 Sep;23(9):1110-4.
PubMed 12370724Arathi R, Ashwini R. Parental presence in the dental operatory-parent's point of view. J Indian Soc Pedod Prev Dent. 1999 Dec;17(4):150-5.
PubMed 10863512Marcum BK, Turner C, Courts FJ. Pediatric dentists' attitudes regarding parental presence during dental procedures. Pediatr Dent. 1995 Nov-Dec;17(7):432-6.
PubMed 8786909
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Objective Assessment of Dental Fear, and the Influence of the Parental Presence on the Behavior of Anxious Children on Their First Restorative Dental Visit
- ClinicalTrials.gov ID
- NCT02619981
- Acronym / sponsor ID
- IRP/2012/48
- Conditions
- Dental Fear
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Riyadh Colleges of Dentistry and PharmacyUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 2 Dec 2015 (estimated)
- 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.
150 children aged between five and seven years presenting for the first dental visit, whose parents consented to participate in the study were selected from patients reporting to the dental clinics Riyadh Colleges of Dentistry and Pharmacy using convenience sampling. Pulse rate for each patient was measured at different clinical situation starting from patient parent separation until end of appointment using a pulse oximeter, Data which collected was statistically analyzed using appropriate statistical analyses using SPSS ver.19 data processing software.
Detailed description
150 children aged between five and seven years presenting for the first dental visit, whose parents consented to participate in the study were selected from patients reporting to the dental clinics Riyadh Colleges of Dentistry and Pharmacy using convenience sampling. Only children who were classified as anxious but able to cope were included in the study (Rating 2 on the Venham's scale).
Pulse rate for each patient was measured at six different clinical situations. 1) Baseline 2) Seating of the child at the chair, 3) Arrival of the dentist, 4) Administration of local anesthesia 5) During the procedure, 6) End of Appointment.
Based on the accompanying person the children were classified as children accompanied by mothers alone, children accompanied by fathers alone, children accompanied by both parents.
The behavior of the child at each situation was recorded using the modified Venham's scale at each interval. The heart rate and oxygen saturation were recorded using pulse oxymetry
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Father present | Active comparator | Procedure: Restorative procedure, Drug: Maxillary infiltration anesthesia with 2%LidocaineChild seated at the dental chair, buccal maxillary infiltration anesthesia with 2%Lidocaine administered using a 27 gauge 21mm needle , restorative procedure completed , Father present |
| Mother Present | Active comparator | Procedure: Restorative procedure, Drug: Maxillary infiltration anesthesia with 2%LidocaineChild seated at the dental chair, buccal maxillary infiltration anesthesia with 2%Lidocaine administered using a 27 gauge 21mm needle , restorative procedure completed , Mother present |
| Both parents present | Active comparator | Procedure: Restorative procedure, Drug: Maxillary infiltration anesthesia with 2%LidocaineChild seated at the dental chair, buccal maxillary infiltration anesthesia with 2%Lidocaine administered using a 27 gauge 21mm needle , restorative procedure completed , both parents present |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- No previous restorative dental experience
- At least one maxillary posterior tooth requiring restorative care
- Parental consent to participate in the study
Key exclusion criteria (3 listed)
- Children with previous restorative dental experience
- Children with intellectual disability
- Children with diagnosed neurobehavioral disorders, including (but not limited to ), Autism spectrum disorders, learning disabilities, cerebral palsy, attention deficit hyperactivity disorder
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 |
|---|---|---|
| Restorative procedureAlso: Dental FillingA restorative dental procedure requiring maxillary buccal infiltration anesthesia, and not exceeding 30 minutes of working time | Procedure or surgery | Both parents present, Father present, Mother Present |
| Maxillary infiltration anesthesia with 2%LidocaineAlso: 2% Lignociane1.8ml of 2% Lidocaine with adrenaline administered using a 27 gauge 21mm needle | Drug | Both parents present, Father present, Mother Present |
Primary outcome
Child behavior - Subjective
Time frame: 30min
Child behavior monitored using the Venham scale
1 secondary outcome
Child Behavior - Objective
Time frame: 30 min
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 2 Dec 2015.
- Background: PubMed 21806904Cox IC, Krikken JB, Veerkamp JS. Influence of parental presence on the child's perception of, and behaviour, during dental treatment. Eur Arch Paediatr Dent. 2011 Aug;12(4):200-4. doi: 10.1007/BF03262807.
- Background: PubMed 23056787Afshar H, Baradaran Nakhjavani Y, Mahmoudi-Gharaei J, Paryab M, Zadhoosh S. The Effect of Parental Presence on the 5 year-Old Children's Anxiety and Cooperative Behavior in the First and Second Dental Visit. Iran J Pediatr. 2011 Jun;21(2):193-200.
- Background: PubMed 12370724Al-Shalan TA, Al-Musa BA, Al-Khamis AM. Parents' attitude towards children's first dental visit in the College of Dentistry, Riyadh, Saudi Arabia. Saudi Med J. 2002 Sep;23(9):1110-4.
- Background: PubMed 10863512Arathi R, Ashwini R. Parental presence in the dental operatory-parent's point of view. J Indian Soc Pedod Prev Dent. 1999 Dec;17(4):150-5.
- Background: PubMed 8786909Marcum BK, Turner C, Courts FJ. Pediatric dentists' attitudes regarding parental presence during dental procedures. Pediatr Dent. 1995 Nov-Dec;17(7):432-6.
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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.
Hezekiah Mosadomi, DMD study director
Riyadh Colleges of Dentistry and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Restorative procedure and Maxillary infiltration anesthesia with 2%Lidocaine in people with Dental Fear, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
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 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 2 Dec 2015. 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 Saudi Arabia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Child behavior - Subjective (time frame: 30min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02619981, which also lists 5 linked publications.
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 2 Dec 2015.