Pediatric Dental General AnesthesiaNCT07827833
Clinical Performance and Failure Rates of Restorations Following Pediatric Dental Rehabilitation Under General Anesthesia
An observational study of Pediatric Dental General Anesthesia and Restoration, run by Tanta University at 1 site in Egypt.
Trial summary
Full-mouth dental rehabilitation under general anesthesia (GA) is frequently required for young children with extensive dental caries, behavioral challenges, or special healthcare needs. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Pediatric Dental General Anesthesia, Restoration, Clinical Performance
- What is being tested?
- Routine Restorative Materials and Treatment Methods
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Aug 2025to Sep 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population will consist of children aged 3-6 years who require comprehensive full-mouth dental rehabilitation under general anesthesia because of extensive dental caries and/or extensive restorative treatment needs. Participants will receive restorative and full-coverage dental treatments as part of routine clinical care, with the selection of restorative materials and treatment methods determined by the treating clinician according to the child's clinical needs. Participants will be prospectively followed for 24 months to evaluate the clinical performance, survival, and failure rates of the restorations placed during dental rehabilitation.
Who may be able to join
- Children requiring comprehensive/full-mouth dental rehabilitation under general anesthesia because of extensive dental treatment needs.
- Children receiving restorative and/or full-coverage dental treatments as part of routine clinical care.
- Children whose parents provide written informed consent for participation and follow-up.
- Children whose planned treatment allows clinical evaluation of the restorations for the intended 24-month follow-up period.
- Children whose parents or legal guardians are willing and able to attend the scheduled follow-up visits for up to 24 months.
Who cannot join
- Children for whom the planned dental rehabilitation cannot be completed because of medical or anesthetic considerations.
- Children with systemic or medical conditions that are expected to substantially affect oral healing, caries progression, or restoration survival.
- Children unlikely to attend or complete the scheduled 24-month follow-up.
- Children with inadequate clinical records or insufficient baseline information required for assessment of restoration outcomes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
faculty of dentistry, Tanta university
Tanta
shaimaa eldesouky, assistant professor, 01008994242, shaimaaeldesouky@dent.tanta.edu.eg
About this study
Official title: Clinical Outcomes and Failure Rates of Restorative Treatments Following Full-Mouth Dental Rehabilitation Under General Anesthesia in Children
Full-mouth dental rehabilitation under general anesthesia (GA) is frequently required for young children with extensive dental caries, behavioral challenges, or special healthcare needs. Although various restorative materials and treatment approaches are used during comprehensive dental rehabilitation, evidence regarding their long-term clinical performance and failure rates remains limited. Objective: This prospective cohort study aims to evaluate the clinical outcomes and failure rates of restorative materials and methods employed during full-mouth dental rehabilitation under general anesthesia in children over a two-year follow-up period. Methods: Children undergoing full-mouth dental rehabilitation under general anesthesia will be enrolled and followed prospectively for 24 months. Restorative procedures, including direct and indirect restorative treatments, pulp therapy-associated restorations, and full-coverage restorations, will be performed according to standardized clinical protocols. Clinical evaluations will be conducted at scheduled follow-up visits to assess restoration survival, integrity, recurrent caries, need for retreatment, and restoration failure. Failure rates and factors associated with restoration success or failure will be analyzed.
Read the detailed description
Early childhood caries and extensive dental disease remain significant oral health problems among children worldwide. In many cases, comprehensive dental treatment under general anesthesia (GA) is required to manage young children who exhibit extensive treatment needs, lack of cooperation, dental anxiety, behavioral limitations, or special healthcare needs. Full-mouth dental rehabilitation under GA enables the delivery of comprehensive restorative and preventive dental care in a single session, improving oral health and quality of life for affected children. A variety of restorative materials and treatment methods are routinely employed during pediatric dental rehabilitation under GA, including resin composite restorations, glass ionomer-based restorations, stainless steel crowns, esthetic full-coverage crowns, and restorations associated with pulp therapy procedures. Despite their widespread use, the long-term clinical performance and survival of these restorative approaches may vary according to material characteristics, tooth type, extent of carious destruction, patient-related factors, and oral hygiene practices. Restoration failure may result from recurrent caries, loss of restoration, marginal deterioration, fracture, wear, or the need for replacement or retreatment.
Although several studies have evaluated restorative outcomes in pediatric patients, evidence comparing the long-term success and failure rates of restorative materials and techniques used during full-mouth dental rehabilitation under GA remains limited. Furthermore, most available studies have reported variable follow-up periods and heterogeneous outcome measures, making it difficult to establish evidence-based recommendations for restorative treatment selection.
The purpose of this prospective cohort study is to evaluate the clinical outcomes and failure rates of restorative materials and methods employed during children's full-mouth dental rehabilitation under general anesthesia over a two-year follow-up period. Children receiving comprehensive dental treatment under GA will be enrolled and monitored at predetermined follow-up intervals. Clinical assessments will evaluate restoration survival, retention, marginal integrity, recurrent caries, restoration fracture, need for repair or replacement, and overall treatment success. The cumulative survival and failure rates of different restorative materials and treatment methods will be determined, and factors associated with restoration longevity will be investigated.
- Conditions
- Pediatric Dental General Anesthesia, Restoration, Clinical Performance, Full Mouth Rehabilitation
- Being tested
- Routine Restorative Materials and Treatment Methods
- Keywords
- General Anesthesia, Full-Mouth Dental Rehabilitation, Restorative Materials, restoration Failure, Early Childhood Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Restorative Materials and Treatment MethodsOther
Restorative materials and treatment methods routinely employed during full-mouth dental rehabilitation under general anesthesia, including direct restorations and full-coverage restorations such as composite resin restorations, glass ionomer-based restorations, stainless steel crowns, and other clinically indicated restorative approaches. The selection of restorative material and treatment method will be determined by the treating clinician according to the child's clinical needs and standard clinical practice. The study investigators will not assign or randomize participants to any restorative material or treatment method. These restorative treatments will be observed prospectively to evaluate their clinical performance, survival, and failure rates over a 24-month follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| Children Undergoing Full-Mouth Dental Rehabilitation Under General Anesthesia | Children undergoing full-mouth dental rehabilitation under general anesthesia as part of routine clinical care will be prospectively enrolled and followed for 24 months. Restorative materials and treatment methods will be selected by the treating clinicians according to the child's clinical condition, tooth type, extent of caries, remaining tooth structure, pulp status, and standard clinical indications. No restorative material or treatment method will be assigned by the study investigators. The clinical performance, survival, and failure of restorations placed during routine treatment will be evaluated at scheduled follow-up visits over a two-year period. Receives: Other: Routine Restorative Materials and Treatment Methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration Failure Rate Over 24 Months
The proportion of restorations that experience failure during the 24-month follow-up period. Restoration failure will include recurrent caries, loss or debonding of the restoration, fracture, unacceptable marginal deterioration, or the need for restoration replacement, repair, or retreatment.
Measured: Baseline to 24 months
Secondary outcomes (4)
Cumulative Restoration Failure Rate According to Restorative Material
Comparison of cumulative failure rates among the restorative materials routinely used during rehabilitation, such as composite resin, glass ionomer-based restorations, stainless steel crowns, and other clinically indicated restorative materials.
Measured: 3, 6, 12, 18, and 24 months
Types of Restoration Failure Assessed Using Modified United States Public Health Service (USPHS/Ryge) Criteria
Frequency and distribution of restoration failure modes assessed according to the modified United States Public Health Service (USPHS/Ryge) criteria. Failure modes include recurrent caries, loss of restoration retention, restoration fracture, marginal deterioration, excessive wear, and the need for repair, replacement, or retreatment. Restorations will be evaluated using USPHS ratings (Alpha, Bravo, Charlie, and Delta), where Alpha represents ideal clinical performance and Charlie/Delta ratings indicate clinically unacceptable conditions requiring intervention or replacement.
Measured: 3, 6, 12, 18, and 24 months
Restoration Failure According to Tooth Type and Location
Evaluation of restoration failure according to tooth type, primary anterior versus posterior teeth, maxillary versus mandibular arch, and other relevant tooth-related characteristics.
Measured: 3, 6, 12, 18, and 24 months
Overall Treatment Success Following Full-Mouth Dental Rehabilitation
Proportion of children completing the 24-month follow-up without major treatment failure requiring additional operative dental treatment under general anesthesia.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start3 Aug 2025
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pediatric Dental General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Shaban Mohamed El-desouky, Tanta University
- Investigators
- shaimaa S eldesouky, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827833
- Sponsor's protocol ID
- #R-PED-7-25-3211
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alhissan AS, Pani SC. Factors Influencing the Survival of Preformed Zirconia Crowns in Children Treated under General Anesthesia. Int J Dent. 2021 Mar 17;2021:5515383. doi: 10.1155/2021/5515383. eCollection 2021.
PubMed 33833801Tate AR, Ng MW, Needleman HL, Acs G. Failure rates of restorative procedures following dental rehabilitation under general anesthesia. Pediatr Dent. 2002 Jan-Feb;24(1):69-71.
PubMed 11874065Mathew MG, Jeevanandan G. Evaluation of Factors Affecting Clinical Outcomes of Full Mouth Rehabilitation Under General Anaesthesia for Children With Early Childhood Caries: A Prospective Cohort Study. Cureus. 2023 Oct 10;15(10):e46778. doi: 10.7759/cureus.46778. eCollection 2023 Oct.
PubMed 37954807
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes and Failure Rates of Restorative Treatments Following Full-Mouth Dental Rehabilitation Under General Anesthesia in Children
- ClinicalTrials.gov ID
- NCT07827833
- Acronym / sponsor ID
- #R-PED-7-25-3211
- Conditions
- Pediatric Dental General Anesthesia, Restoration, Clinical Performance, Full Mouth Rehabilitation
- Keywords
- General Anesthesia, Full-Mouth Dental Rehabilitation, Restorative Materials, restoration Failure, Early Childhood Caries
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 3 Aug 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 18 Sep 2026 (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.
Full-mouth dental rehabilitation under general anesthesia (GA) is frequently required for young children with extensive dental caries, behavioral challenges, or special healthcare needs. Although various restorative materials and treatment approaches are used during comprehensive dental rehabilitation, evidence regarding their long-term clinical performance and failure rates remains limited. Objective: This prospective cohort study aims to evaluate the clinical outcomes and failure rates of restorative materials and methods employed during full-mouth dental rehabilitation under general anesthesia in children over a two-year follow-up period. Methods: Children undergoing full-mouth dental rehabilitation under general anesthesia will be enrolled and followed prospectively for 24 months. Restorative procedures, including direct and indirect restorative treatments, pulp therapy-associated restorations, and full-coverage restorations, will be performed according to standardized clinical protocols. Clinical evaluations will be conducted at scheduled follow-up visits to assess restoration survival, integrity, recurrent caries, need for retreatment, and restoration failure. Failure rates and factors associated with restoration success or failure will be analyzed.
Detailed description
Early childhood caries and extensive dental disease remain significant oral health problems among children worldwide. In many cases, comprehensive dental treatment under general anesthesia (GA) is required to manage young children who exhibit extensive treatment needs, lack of cooperation, dental anxiety, behavioral limitations, or special healthcare needs. Full-mouth dental rehabilitation under GA enables the delivery of comprehensive restorative and preventive dental care in a single session, improving oral health and quality of life for affected children. A variety of restorative materials and treatment methods are routinely employed during pediatric dental rehabilitation under GA, including resin composite restorations, glass ionomer-based restorations, stainless steel crowns, esthetic full-coverage crowns, and restorations associated with pulp therapy procedures. Despite their widespread use, the long-term clinical performance and survival of these restorative approaches may vary according to material characteristics, tooth type, extent of carious destruction, patient-related factors, and oral hygiene practices. Restoration failure may result from recurrent caries, loss of restoration, marginal deterioration, fracture, wear, or the need for replacement or retreatment.
Although several studies have evaluated restorative outcomes in pediatric patients, evidence comparing the long-term success and failure rates of restorative materials and techniques used during full-mouth dental rehabilitation under GA remains limited. Furthermore, most available studies have reported variable follow-up periods and heterogeneous outcome measures, making it difficult to establish evidence-based recommendations for restorative treatment selection.
The purpose of this prospective cohort study is to evaluate the clinical outcomes and failure rates of restorative materials and methods employed during children's full-mouth dental rehabilitation under general anesthesia over a two-year follow-up period. Children receiving comprehensive dental treatment under GA will be enrolled and monitored at predetermined follow-up intervals. Clinical assessments will evaluate restoration survival, retention, marginal integrity, recurrent caries, restoration fracture, need for repair or replacement, and overall treatment success. The cumulative survival and failure rates of different restorative materials and treatment methods will be determined, and factors associated with restoration longevity will be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children Undergoing Full-Mouth Dental Rehabilitation Under General Anesthesia | – | Other: Routine Restorative Materials and Treatment MethodsChildren undergoing full-mouth dental rehabilitation under general anesthesia as part of routine clinical care will be prospectively enrolled and followed for 24 months. Restorative materials and treatment methods will be selected by the treating clinicians according to the child's clinical condition, tooth type, extent of caries, remaining tooth structure, pulp status, and standard clinical indications. No restorative material or treatment method will be assigned by the study investigators. The clinical performance, survival, and failure of restorations placed during routine treatment will be evaluated at scheduled follow-up visits over a two-year period. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population will consist of children aged 3-6 years who require comprehensive full-mouth dental rehabilitation under general anesthesia because of extensive dental caries and/or extensive restorative treatment needs. Participants will receive restorative and full-coverage dental treatments as part of routine clinical care, with the selection of restorative materials and treatment methods determined by the treating clinician according to the child's clinical needs. Participants will be prospectively followed for 24 months to evaluate the clinical performance, survival, and failure rates of the restorations placed during dental rehabilitation.
Key inclusion criteria (5 listed)
- Children requiring comprehensive/full-mouth dental rehabilitation under general anesthesia because of extensive dental treatment needs.
- Children receiving restorative and/or full-coverage dental treatments as part of routine clinical care.
- Children whose parents provide written informed consent for participation and follow-up.
- Children whose planned treatment allows clinical evaluation of the restorations for the intended 24-month follow-up period.
- Children whose parents or legal guardians are willing and able to attend the scheduled follow-up visits for up to 24 months.
Key exclusion criteria (4 listed)
- Children for whom the planned dental rehabilitation cannot be completed because of medical or anesthetic considerations.
- Children with systemic or medical conditions that are expected to substantially affect oral healing, caries progression, or restoration survival.
- Children unlikely to attend or complete the scheduled 24-month follow-up.
- Children with inadequate clinical records or insufficient baseline information required for assessment of restoration outcomes.
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 |
|---|---|---|
| Routine Restorative Materials and Treatment MethodsRestorative materials and treatment methods routinely employed during full-mouth dental rehabilitation under general anesthesia, including direct restorations and full-coverage restorations such as composite resin restorations, glass ionomer-based restorations, stainless steel crowns, and other clinically indicated restorative approaches. The selection of restorative material and treatment method will be determined by the treating clinician according to the child's clinical needs and standard clinical practice. The study investigators will not assign or randomize participants to any restorative material or treatment method. These restorative treatments will be observed prospectively to evaluate their clinical performance, survival, and failure rates over a 24-month follow-up period. | Other | Children Undergoing Full-Mouth Dental Rehabilitation Under General Anesthesia |
Primary outcome
Restoration Failure Rate Over 24 Months
Time frame: Baseline to 24 months
The proportion of restorations that experience failure during the 24-month follow-up period. Restoration failure will include recurrent caries, loss or debonding of the restoration, fracture, unacceptable marginal deterioration, or the need for restoration replacement, repair, or retreatment.
4 secondary outcomes
Cumulative Restoration Failure Rate According to Restorative Material
Time frame: 3, 6, 12, 18, and 24 months
Types of Restoration Failure Assessed Using Modified United States Public Health Service (USPHS/Ryge) Criteria
Time frame: 3, 6, 12, 18, and 24 months
Restoration Failure According to Tooth Type and Location
Time frame: 3, 6, 12, 18, and 24 months
Overall Treatment Success Following Full-Mouth Dental Rehabilitation
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Results publication: PubMed 33833801Alhissan AS, Pani SC. Factors Influencing the Survival of Preformed Zirconia Crowns in Children Treated under General Anesthesia. Int J Dent. 2021 Mar 17;2021:5515383. doi: 10.1155/2021/5515383. eCollection 2021.
- Results publication: PubMed 11874065Tate AR, Ng MW, Needleman HL, Acs G. Failure rates of restorative procedures following dental rehabilitation under general anesthesia. Pediatr Dent. 2002 Jan-Feb;24(1):69-71.
- Results publication: PubMed 37954807Mathew MG, Jeevanandan G. Evaluation of Factors Affecting Clinical Outcomes of Full Mouth Rehabilitation Under General Anaesthesia for Children With Early Childhood Caries: A Prospective Cohort Study. Cureus. 2023 Oct 10;15(10):e46778. doi: 10.7759/cureus.46778. eCollection 2023 Oct.
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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.
shaimaa S eldesouky principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Dental General Anesthesia and Restoration, run by Tanta University at 1 site in Egypt.
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 4 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: looking for participants now, as of the sponsor's last update on 22 Sep 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shaimaa eldesouky (01008994242, shaimaaeldesouky@dent.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoration Failure Rate Over 24 Months (time frame: Baseline to 24 months). 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 NCT07827833, which also lists 3 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 22 Sep 2026.