Approximal Dental Caries (ICDAS 3-5) in Primary Molars of ChildrenNCT06350578

A Randomized Clinical Trial Comparing Hall vs. Conventional Technique in Primary Molars.

A study testing Hall Crown Technique and Conventional SSC Technique in people with Approximal Dental Caries (ICDAS 3-5) in Primary Molars of Children, run by Primary Health Care Corporation, Qatar at 1 site in Qatar.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to assess the comparative effectiveness of the Hall technique (HT) and the conventional technique (CT) for placing Stainless Steel Crowns (SSCs) in primary molars with approximal caries. Read more about this study

Who is it for?: Ages 3 to 9 years
Conditions the study is for: Approximal Dental Caries (ICDAS 3-5) in Primary Molars of Children
What is being tested?: Hall Crown Technique and Conventional SSC Technique
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteQatar
Study dates: 6 Dec 2023to 1 Aug 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 3 to 9 years
All sexes
No healthy volunteers
Child

Who may be able to join

Participant inclusion criteria:
PHCC paediatric dental patients:
Whose parents or legal guardians accept and sign the consent form
Who assent to participation.
Who aged 3-9 years old.
Who exhibit generally cooperative behavior.

Show all 10Show fewer

Who exhibit good general health conditions.
Who are presenting at least one occluso-proximal lesion in a primary molar.
Tooth/ carious lesion inclusion criteria:
1. From clinical and radiographic examination, caries limited to the occluso-proximal surfaces and extending to enamel or dentine, cavitated or non cavitated.

Who cannot join

Uncooperative children who do not understand the procedure or tolerate biting the crown into its position without local anesthesia.
Children with special health care needs (SHCN) will be excluded.
Children with nickel allergies and sensitivity.
Tooth/ caries lesion exclusion criteria:
Tooth with signs or symptoms of dental infection or irreversible pulpitis such as:
A history of spontaneous unprovoked pain, a sinus tract, soft tissue inflammation not resulting from gingivitis or periodontitis, excessive mobility not associated with trauma or exfoliation, furcation/ apical radiolucency, or radiographic evidence of internal/ external resorption (Camp JH 2011).
Crowns severely destructed with caries, which considered non-restorable (Innes, N.P 2009).
Teeth with single surface (occlusal) caries.

Trial locations and contacts

1 site in 1 country.

Qatar1 site

Primary Healthcare Corporation
Doha

Other trials in Qatar

About this study

Official title: Comparative Analysis of Hall Technique and Conventional Method for Stainless Steel Crown Placement in Primary Molars With Approximal Caries: A Randomized Controlled Trial at Primary Healthcare Corporation, Qatar

Read the detailed description

Background:

The most common chronic disease in children and adolescents (6-19 years old) is dental caries. The conventional approach to treating carious lesions involves cavity preparation with rotary instruments, followed by restoration using composite resin, amalgam, or stainless steel crowns (SSCs).

Retrospective studies have shown that SSCs have a higher success rate compared to amalgam or resin-based restorations when used for multi-surface caries in primary teeth. Accordingly, the American Academy of Paediatric Dentistry (AAPD) recommends the use of SSCs as the treatment of choice for carious lesions involving more than one surface in high-risk children.

Recently, the Hall Technique (HT) has been used to seal caries in primary molars. This contemporary technique was first introduced in the literature in 2006 by Dr Norna Hall, while working in a high caries-risk area in rural Scotland. The technique is based on straightforward biological principles: the most important layer for caries progression- the superficial plaque layer- is left intact and sealed along with the carious lesion. This leads to the development of a less cariogenic flora within the plaque biofilm, thereby arresting or slowing the caries progression in primary teeth.

The Hall Technique involves cementing an SSC over a carious primary tooth without the use of rotary instruments or local anaesthesia, thus reducing discomfort and improving the child's behaviour during treatment.

Aim:

The study aims to compare the Hall Technique (HT) and Conventional Restoration (CR) using stainless steel crowns (SSCs) in terms of clinical effectiveness, changes in occlusal vertical dimension (OVD), procedural time, child pain perception and cooperation, as well as parental acceptability of both techniques.

Methods/Design:

Approximal dental caries (ICDAS 3-5) in primary molars of children aged 3 to 9 years will be managed using two treatment techniques: conventional restorations (CR) with stainless steel crowns (SSCs) and the Hall Technique (HT). The study will be a binary outcome, non-inferiority randomised trial conducted in a primary care dental clinic setting. The study protocol will follow the Consolidated Standards of Reporting Trials (CONSORT) guidelines for randomised trials of non-pharmacologic treatments. Participants will be randomly allocated to receive SSCs placed using either the conventional technique (CT, control group) or the Hall Technique (HT, experimental group), in order to compare different approaches for managing occluso-proximal caries lesions in primary molars.

Discussion:

This clinical trial aims to determine whether the Hall Technique (HT) provides clinical outcomes that are not inferior to those of conventional restorations (CR) using stainless steel crowns (SSCs) in the management of approximal caries in primary molars. The study will also assess child pain perception, cooperation, and parental acceptability, to support the use of minimally invasive techniques in paediatric dental care.

Conditions: Approximal Dental Caries (ICDAS 3-5) in Primary Molars of Children
Being tested: Hall Crown Technique, Conventional SSC Technique
Keywords: Hall Technique, Conventional Restoration, Stainless Steel Crowns, Approximal Caries, Paediatric Dentistry, Non-inferiority Trial, Minimally Invasive Dentistry, Pain Perception, Parental Acceptability, Occlusal Vertical Dimension, Restoration Survival, Tooth Survival, Randomised Controlled Trial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hall Crown TechniqueProcedure or surgery
The Hall technique (HT) involves cementing Stainless Steel Crowns SSC on carious primary teeth without using rotary instruments nor local anaesthesia, thus eliminating discomfort, and increasing child's behavior.
Conventional SSC TechniqueProcedure or surgery
The conventional technique involves complete removal of the carious lesion using rotary instruments and local anesthesia, then restoring the tooth with Stainless Steel Crown SSC.

Study groups in NCT06350578
Study group	Role	What they receive
Hall Crown Technique	Experimental	HT is a conservative restorative technique used for primary molars with single- or multi-surface carious lesions. This technique involves cementing a SSC directly over the affected primary molar without any caries removal or tooth reduction. Receives: Procedure: Hall Crown Technique
Conventional SSC Technique	Active comparator	CT is the traditional restorative technique often used for primary molars with multi-surface carious lesions. This technique involves caries removal and occlusal-proximal tooth surface reduction before crown cementation. Receives: Procedure: Conventional SSC Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

Restoration survival over 12 months
Success:
- Satisfactory restoration/crown, no intervention required
- No clinical or radiographic signs or symptoms of pulp pathology
- Tooth exfoliated
Minor Failures:
- Secondary caries or new lesions detected clinically
- Crown presents perforation
- Restoration fracture or wear - intervention required
- Loss of restoration - tooth that can be re-restored
- Crown loss - tooth able to be re-treated
- Reversible pulpitis, which could be treated without the need for extraction or pulpotomy
Major Failures:
- Irreversible pulpitis or dental fistula/abscess requiring pulpotomy or extraction
- Loss of restoration/crown - tooth not capable of being re-restored
- Periradicular and/or furcation radiolucency
Measured: At 1 month, 6 months, 9 months, and 12 months post-treatment
Occlusal Vertical Dimension (OVD) resolution
Will be assessed only in the HT group using a millimetre dental probe.
Measured: Assessments will be conducted at baseline (before treatment), immediately after crown placement, and at follow-up visits at 1, 6, 9, and 12 months post-treatment, with particular emphasis on the 1-month follow-up.

Secondary outcomes (5)

Tooth survival over 12 months
Teeth with treatments scored as satisfactory or with minor failures will be classified as "successful," while teeth presenting major failures will be considered as "failure for tooth." Data related to the treated tooth will be collected for both groups.
Measured: At 1 month, 6 months, 9 months, and 12 months post-treatment
Procedural Time
Will be recorded during the treatment visit using a stopwatch for both the Hall Technique and the Conventional Technique.
Measured: At the time of treatment visit
Participant's cooperation
Participant cooperation will be assessed and compared between the two intervention groups using the Frankl Behaviour Rating Scale.
Measured: At the time of treatment visit
Participant's pain perception
Pain perception will be assessed and compared between the two intervention groups using the Wong-Baker Faces Pain Scale (WBFPS).
Measured: At the time of treatment visit
Parents' perceptions and opinions regarding treatment
A five-point Likert scale will be used to assess the following:
- Child's behaviour during treatment
- Comfort during treatment
- Satisfaction with treatment undertaken
- Dentist's ease of treatment provision
- Perceived duration of the procedure
- Willingness to choose the same treatment option again
Measured: At the time of treatment visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Dec 20231 Aug 2025

First posted5 Apr 2024
Study start6 Dec 2023
Primary completion27 Jul 2025
Study completion1 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (38)Papers the sponsor has linked to this study.
Other trials for Approximal Dental Caries (ICDAS 3-5) in Primary Molars of 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: Parallel groups
Model description: A binary outcome non-inferiority randomised trial.
Masking: Single blind
Who is masked: Care provider
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06350578
Sponsor's protocol ID: BUHOOTH-D-23-00073
Status last verified: Mar 2025
First submitted: 24 Mar 2024
Last updated: 25 Sep 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Alshoraim MA, El-Housseiny AA, Farsi NM, Felemban OM, Alamoudi NM, Alandejani AA. Effects of child characteristics and dental history on dental fear: cross-sectional study. BMC Oral Health. 2018 Mar 7;18(1):33. doi: 10.1186/s12903-018-0496-4.
PubMed 29514657
Araujo MP, Innes NP, Bonifacio CC, Hesse D, Olegario IC, Mendes FM, Raggio DP. Atraumatic restorative treatment compared to the Hall Technique for occluso-proximal carious lesions in primary molars; 36-month follow-up of a randomised control trial in a school setting. BMC Oral Health. 2020 Nov 11;20(1):318. doi: 10.1186/s12903-020-01298-x.
PubMed 33176756
Ayedun OS, Oredugba FA, Sote EO. Comparison of the treatment outcomes of the conventional stainless steel crown restorations and the hall technique in the treatment of carious primary molars. Niger J Clin Pract. 2021 Apr;24(4):584-594. doi: 10.4103/njcp.njcp_460_20.
PubMed 33851682
Badar SB, Tabassum S, Khan FR, Ghafoor R. Effectiveness of Hall Technique for Primary Carious Molars: A Systematic Review and Meta-analysis. Int J Clin Pediatr Dent. 2019 Sep-Oct;12(5):445-452. doi: 10.5005/jp-journals-10005-1666.
PubMed 32440052
Barretto Ede P, Ferreira e Ferreira E, Pordeus IA. Evaluation of toothache severity in children using a visual analogue scale of faces. Pediatr Dent. 2004 Nov-Dec;26(6):485-91.
PubMed 15646909
Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P; CONSORT Group. Methods and processes of the CONSORT Group: example of an extension for trials assessing nonpharmacologic treatments. Ann Intern Med. 2008 Feb 19;148(4):W60-6. doi: 10.7326/0003-4819-148-4-200802190-00008-w1.
PubMed 18283201
Boyd DH, Page LF, Thomson WM. The Hall Technique and conventional restorative treatment in New Zealand children's primary oral health care - clinical outcomes at two years. Int J Paediatr Dent. 2018 Mar;28(2):180-188. doi: 10.1111/ipd.12324. Epub 2017 Aug 8.
PubMed 28787534
Boyd DH, Thomson WM, Leon de la Barra S, Fuge KN, van den Heever R, Butler BM, Leov F, Foster Page LA. A Primary Care Randomized Controlled Trial of Hall and Conventional Restorative Techniques. JDR Clin Trans Res. 2021 Apr;6(2):205-212. doi: 10.1177/2380084420933154. Epub 2020 Jun 19.
PubMed 32559403
Chua DR, Tan BL, Nazzal H, Srinivasan N, Duggal MS, Tong HJ. Outcomes of preformed metal crowns placed with the conventional and Hall techniques: A systematic review and meta-analysis. Int J Paediatr Dent. 2023 Mar;33(2):141-157. doi: 10.1111/ipd.13029. Epub 2022 Oct 17.
PubMed 36151937
Ebrahimi M, Shirazi AS, Afshari E. Success and Behavior During Atraumatic Restorative Treatment, the Hall Technique, and the Stainless Steel Crown Technique for Primary Molar Teeth. Pediatr Dent. 2020 May 15;42(3):187-192.
PubMed 32522320
Elamin F, Abdelazeem N, Salah I, Mirghani Y, Wong F. A randomized clinical trial comparing Hall vs conventional technique in placing preformed metal crowns from Sudan. PLoS One. 2019 Jun 3;14(6):e0217740. doi: 10.1371/journal.pone.0217740. eCollection 2019.
PubMed 31158253
Erdemci ZY, Cehreli SB, Tirali RE. Hall versus conventional stainless steel crown techniques: in vitro investigation of marginal fit and microleakage using three different luting agents. Pediatr Dent. 2014 Jul-Aug;36(4):286-90.
PubMed 25197992
Eriksson AL, Paunio P, Isotupa K. Restoration of deciduous molars with ion-crowns: retention and subsequent treatment. Proc Finn Dent Soc. 1988;84(2):95-9. No abstract available.
PubMed 3134654
Fayle SA. UK National Clinical Guidelines in Paediatric Dentistry. Stainless steel preformed crowns for primary molars. Faculty of Dental Surgery, Royal College of Surgeons. Int J Paediatr Dent. 1999 Dec;9(4):311-4. doi: 10.1046/j.1365-263x.1999.00153.x. No abstract available.
PubMed 10815591
Frencken JE. Atraumatic restorative treatment and minimal intervention dentistry. Br Dent J. 2017 Aug 11;223(3):183-189. doi: 10.1038/sj.bdj.2017.664.
PubMed 28798450

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Analysis of Hall Technique and Conventional Method for Stainless Steel Crown Placement in Primary Molars With Approximal Caries: A Randomized Controlled Trial at Primary Healthcare Corporation, Qatar
ClinicalTrials.gov ID: NCT06350578
Acronym / sponsor ID: BUHOOTH-D-23-00073
Conditions: Approximal Dental Caries (ICDAS 3-5) in Primary Molars of Children
Keywords: Hall Technique, Conventional Restoration, Stainless Steel Crowns, Approximal Caries, Paediatric Dentistry, Non-inferiority Trial, Minimally Invasive Dentistry, Pain Perception
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Primary Health Care Corporation, QatarOther government
Study start: 6 Dec 2023 (actual)
Primary completion: 27 Jul 2025 (actual)
Study completion: 1 Aug 2025 (actual)
First posted: 5 Apr 2024 (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.

Detailed description

Background:

Aim:

Methods/Design:

Discussion:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (care provider)
Number of arms: 2
Model description: A binary outcome non-inferiority randomised trial.

Arm	Type	Receives
Hall Crown Technique	Experimental	Procedure: Hall Crown TechniqueHT is a conservative restorative technique used for primary molars with single- or multi-surface carious lesions. This technique involves cementing a SSC directly over the affected primary molar without any caries removal or tooth reduction.
Conventional SSC Technique	Active comparator	Procedure: Conventional SSC TechniqueCT is the traditional restorative technique often used for primary molars with multi-surface carious lesions. This technique involves caries removal and occlusal-proximal tooth surface reduction before crown cementation.

Who may qualify

Ages: 3 to 9 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (10 listed)

Participant inclusion criteria:
Whose parents or legal guardians accept and sign the consent form
Who assent to participation.
Who aged 3-9 years old.
Who exhibit generally cooperative behavior.

Key exclusion criteria (8 listed)

Uncooperative children who do not understand the procedure or tolerate biting the crown into its position without local anesthesia.
Children with special health care needs (SHCN) will be excluded.
Children with nickel allergies and sensitivity.
Tooth with signs or symptoms of dental infection or irreversible pulpitis such as:
A history of spontaneous unprovoked pain, a sinus tract, soft tissue inflammation not resulting from gingivitis or periodontitis, excessive mobility not associated with trauma or exfoliation, furcation/ apical radiolucency, or radiographic evidence of internal/ external resorption (Camp JH 2011).

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
Hall Crown TechniqueThe Hall technique (HT) involves cementing Stainless Steel Crowns SSC on carious primary teeth without using rotary instruments nor local anaesthesia, thus eliminating discomfort, and increasing child's behavior.	Procedure or surgery	Hall Crown Technique
Conventional SSC TechniqueThe conventional technique involves complete removal of the carious lesion using rotary instruments and local anesthesia, then restoring the tooth with Stainless Steel Crown SSC.	Procedure or surgery	Conventional SSC Technique

Primary outcome

Restoration survival over 12 months
Time frame: At 1 month, 6 months, 9 months, and 12 months post-treatment
Success: * Satisfactory restoration/crown, no intervention required * No clinical or radiographic signs or symptoms of pulp pathology * Tooth exfoliated Minor Failures: * Secondary caries or new lesions detected clinically * Crown presents perforation * Restoration fracture or wear - intervention required * Loss of restoration - tooth that can be re-restored * Crown loss - tooth able to be re-treated * Reversible pulpitis, which could be treated without the need for extraction or pulpotomy Major Failures: * Irreversible pulpitis or dental fistula/abscess requiring pulpotomy or extraction * Loss of restoration/crown - tooth not capable of being re-restored * Periradicular and/or furcation radiolucency
Occlusal Vertical Dimension (OVD) resolution
Time frame: Assessments will be conducted at baseline (before treatment), immediately after crown placement, and at follow-up visits at 1, 6, 9, and 12 months post-treatment, with particular emphasis on the 1-month follow-up.
Will be assessed only in the HT group using a millimetre dental probe.

5 secondary outcomes

Tooth survival over 12 months
Time frame: At 1 month, 6 months, 9 months, and 12 months post-treatment
Procedural Time
Time frame: At the time of treatment visit
Participant's cooperation
Time frame: At the time of treatment visit
Participant's pain perception
Time frame: At the time of treatment visit
Parents' perceptions and opinions regarding treatment
Time frame: At the time of treatment visit

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 25 Sep 2025.
Background: PubMed 29514657Alshoraim MA, El-Housseiny AA, Farsi NM, Felemban OM, Alamoudi NM, Alandejani AA. Effects of child characteristics and dental history on dental fear: cross-sectional study. BMC Oral Health. 2018 Mar 7;18(1):33. doi: 10.1186/s12903-018-0496-4.
Background: PubMed 33176756Araujo MP, Innes NP, Bonifacio CC, Hesse D, Olegario IC, Mendes FM, Raggio DP. Atraumatic restorative treatment compared to the Hall Technique for occluso-proximal carious lesions in primary molars; 36-month follow-up of a randomised control trial in a school setting. BMC Oral Health. 2020 Nov 11;20(1):318. doi: 10.1186/s12903-020-01298-x.
Background: PubMed 33851682Ayedun OS, Oredugba FA, Sote EO. Comparison of the treatment outcomes of the conventional stainless steel crown restorations and the hall technique in the treatment of carious primary molars. Niger J Clin Pract. 2021 Apr;24(4):584-594. doi: 10.4103/njcp.njcp_460_20.
Background: PubMed 32440052Badar SB, Tabassum S, Khan FR, Ghafoor R. Effectiveness of Hall Technique for Primary Carious Molars: A Systematic Review and Meta-analysis. Int J Clin Pediatr Dent. 2019 Sep-Oct;12(5):445-452. doi: 10.5005/jp-journals-10005-1666.
Background: PubMed 15646909Barretto Ede P, Ferreira e Ferreira E, Pordeus IA. Evaluation of toothache severity in children using a visual analogue scale of faces. Pediatr Dent. 2004 Nov-Dec;26(6):485-91.
Background: PubMed 18283201Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P; CONSORT Group. Methods and processes of the CONSORT Group: example of an extension for trials assessing nonpharmacologic treatments. Ann Intern Med. 2008 Feb 19;148(4):W60-6. doi: 10.7326/0003-4819-148-4-200802190-00008-w1.
Background: PubMed 28787534Boyd DH, Page LF, Thomson WM. The Hall Technique and conventional restorative treatment in New Zealand children's primary oral health care - clinical outcomes at two years. Int J Paediatr Dent. 2018 Mar;28(2):180-188. doi: 10.1111/ipd.12324. Epub 2017 Aug 8.
Background: PubMed 32559403Boyd DH, Thomson WM, Leon de la Barra S, Fuge KN, van den Heever R, Butler BM, Leov F, Foster Page LA. A Primary Care Randomized Controlled Trial of Hall and Conventional Restorative Techniques. JDR Clin Trans Res. 2021 Apr;6(2):205-212. doi: 10.1177/2380084420933154. Epub 2020 Jun 19.
Background: PubMed 36151937Chua DR, Tan BL, Nazzal H, Srinivasan N, Duggal MS, Tong HJ. Outcomes of preformed metal crowns placed with the conventional and Hall techniques: A systematic review and meta-analysis. Int J Paediatr Dent. 2023 Mar;33(2):141-157. doi: 10.1111/ipd.13029. Epub 2022 Oct 17.
Background: PubMed 32522320Ebrahimi M, Shirazi AS, Afshari E. Success and Behavior During Atraumatic Restorative Treatment, the Hall Technique, and the Stainless Steel Crown Technique for Primary Molar Teeth. Pediatr Dent. 2020 May 15;42(3):187-192.
Background: PubMed 31158253Elamin F, Abdelazeem N, Salah I, Mirghani Y, Wong F. A randomized clinical trial comparing Hall vs conventional technique in placing preformed metal crowns from Sudan. PLoS One. 2019 Jun 3;14(6):e0217740. doi: 10.1371/journal.pone.0217740. eCollection 2019.
Background: PubMed 25197992Erdemci ZY, Cehreli SB, Tirali RE. Hall versus conventional stainless steel crown techniques: in vitro investigation of marginal fit and microleakage using three different luting agents. Pediatr Dent. 2014 Jul-Aug;36(4):286-90.
Behavior Guidance for the Pediatric Dental PatientLink provided by the sponsor.
Paediatric Restorative DentistryLink provided by the sponsor.
HALL TECHNIQUE VERSUS THE CONVENTIONAL STAINLESS STEEL CROWNS RESTORING CARIOUS PRIMARY MOLAR TEETH: A RANDOMIZED CONTROLLED CLINICAL TRIALLink provided by the sponsor.
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.

Hanan A Mohamed principal investigator

Primary Health Care Corporation (PHCC) of Qatar

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 8 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 25 Sep 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 Qatar. 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?

Restoration survival over 12 months (time frame: At 1 month, 6 months, 9 months, and 12 months post-treatment). The study lists 2 primary outcomes in all. 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 NCT06350578, which also lists 38 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 25 Sep 2025; AzTrials last refreshed its copy on 30 Oct 2026.