Retreat or Replace: Retrospective Investigation on a Cohort of Local Patients

NCT06250114 | Completed

• 1 other identifier: ENDOIMPLUNIBO
• Study Type: observational
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: To evaluate the survival and success rate of premolars with a previous root canal treatment which underwent to non-surgical retreatment or to extraction and implant replacement. Materials and methods: Patients visiting in the Clinical Endodontic Section of the School of Dentistry (University of Bologna) were eligible for the study. Out of these patients, those with previously root canal treated premolars fulfilled the inclusion criteria. Teeth were considered retreatable and restorable (Endo group) or not retreatable and not restorable (Implant group) on the basis of clinical and radiographical examination. Each patient was included in an annual recall programme and final evaluation was performed after 8 years. Clinical parameters were recorded. Differences in baseline characteristics between the two treatment groups were assessed using logistic regression analysis with clustered standard errors. Results were expressed for each variable as odds ratios (ORs) of implant rehabilitation to root canal retreatment with 95% confidence intervals (CIs). Survival and treatment success for the two study groups were estimated using the Kaplan-Meier method. The association of treatment group with time to event was assessed using Cox proportional hazard regression analysis with clustered standard errors to allow for intragroup correlation within teeth belonging to the same patient. Results were expressed as hazard ratios (HRs) of experiencing the study event among implants as compared to root canal retreatments with 95% CIs.

Conditions

Endodontic Disease; Dental Implant Failed; Periapical Diseases

Outcome Measures

Primary Outcomes (2)

• Periapical index (PAI) for retreatment

  PAI 1-2 = no lesions PAI 3-5= periapical lesions

  preoperative, 4 year, 8 years

• Marginal bone levels (MBL) for implant insertion

  MBL measured on periapical radiographs

  during insertion for the implant placement procedure, at 4 years, at 8 years

Secondary Outcomes (1)

• Survival

  4 years 8 years

Study Arms (2)

retreatment

Voluntary patients with at least one previously treated tooth needing a retreatment

Other: Retreatment

dental implant

Voluntary patients with at least one previously treated tooth needing an extraction and implant placement

Other: extraction implant

Interventions

Retreatment OTHER

manual k file, carrier based technique, Xrays, tooth build up, provisional and definitive crowns. Post if necessary will be placed

retreatment

extraction implant OTHER

Flapless or flapped techniques, early, delayed and immediate implant insertions. Cement retrained restorations

dental implant

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Voluntary healthy patients needing a root canal retreatment or an extraction and implant placement

You may qualify if:

• Voluntary healthy patients;
• Age 18-75 years;
• Local geographic provenience;
• Similar socio-economic condition;
• Presence of at least one premolar with a previous root canal treatment requiring a nonsurgical retreatment or extraction and implant rehabilitation;
• Possibility to attend to an annual hygienic recall.

You may not qualify if:

• General contraindication to implant surgeries;
• Absence of implant restoration or endodontic treatment;
• ASA score \>2;
• Diabetes or any condition that could compromise bone healing or immune response;
• Corticosteroid treatment, pregnancy or breast feeding;
• Heavy smoking (\>10 cigarettes/day);
• Exposure to radiation therapy focused on the head and neck region;
• Malignant disease directly involving the jaws.

Sponsors & Collaborators

• University of Bologna: lead

MeSH Terms

Conditions

Dental Pulp Diseases; Periapical Diseases

Interventions

Retreatment; Device Removal

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University of Bologna

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: February 8, 2024
• Study Start: January 12, 2008
• Primary Completion: January 12, 2023
• Study Completion: July 12, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-01