- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07259187
Retrospective Analysis of Complications and Survival of Teeth Restored Following Crown Lengthening
A Retrospective Analysis of Complications and Survival of Teeth Restored With Single Crowns Following Crown Lengthening
The ultimate goal for every dental restoration is to restore and maintain the dentition's functionality along with preserving periodontal support. The long-term success of a restored tooth depends on the retention of a healthy periodontium. When restoring a short clinical crown, the clinician may contemplate placement of subgingival margin to gain additional length for retention purposes. Thus, crown lengthening procedure is performed to gain access to the natural tooth structure while maintaining the periodontal health and to increase the retention of the restoration. A full crown restoration is needed to protect the compromised tooth from fracture. The prognosis of these teeth depends on the long-term success rate of each component of the overall treatment and the follow up maintenance.
In order to assist dentists to make an evidence-based decision during treatment planning, this retrospective study aims to investigate the complications and survival rate of the teeth receiving crown following crown lengthening.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this retrospective study was to evaluate the survival rates and complications of structurally compromised teeth restored with full-coverage crowns following crown lengthening procedure (CLP), in a postgraduate dental setting.
In this retrospective study the records of patients who received surgical CLP prior to receiving full coverage crowns at X hospital between January 2011 to January 2021 were obtained and reviewed by A.AH and F.AR for possible inclusion in the study. Retrospective data were collected manually from digital records of registered patients (Dental4windows, Centaur Software Development Co Pty Ltd., Australia). All personal information is de-identified and securely stored with a study code number. The data were then organized into categories based on a pre-determined form for single crowns with CLP .
The calculation of sample size was based on a 10-year survival rate of 78.4% tooth preservation after crown lengthening procedure and restorative treatment in department of periodontics and oral medicine at the school of dentistry of the university of Michigan (where p is the prevalence of crown after crown lengthening, d is the precision of the estimate, and z_(α/2)^2 is the quartile of the 95% confidence interval).
Using the above equation and data from the aforementioned study, the sample size needed is determined to be 260 teeth.
Statistical Analysis The collected data will be transferred to Statistical Package for Social Sciences (SPSS) for Windows (IBM- SPSS) version 25.0 (SPSS Inc., Chicago, IL, USA) for statistical analysis.
Significance for statistical analysis will be set at P < 0.05. Chi-square analysis will be used to measure the association strength between the frequency of both the survival of crown after crown lengthening and the complications. Kaplan-Meier will be used for analysis of the survival and Logistic regression will be used for the potential risk factors. P values <0.05 will be considered as a statistically significant.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Dubai, United Arab Emirates
- Dubai Dental Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: Patients were included in the study if they met all the following conditions:
- Setting and Providers: The tooth received crown lengthening surgery (CLP) performed by postgraduate residents in Periodontology and subsequent definitive crown placement by postgraduate residents in Prosthodontics at X Hospital.
- Patient Characteristics:
Age between 18 and 70 years at the time of the CLP. Able and willing to participate, with written informed consent obtained.
- Follow-up and Documentation Requirements: A minimum of 12 months had elapsed since placement of the definitive crown at the time of data collection. Baseline intraoral radiographs available prior to CLP to document periodontal and structural condition.
- Tooth-Level Clinical Criteria: Tooth mobility not exceeding Miller Class I at baseline. A planned or anticipated crown-root ratio ≥1:1 following CLP based on clinical and radiographic evaluation.
Exclusion Criteria: Patients were excluded if any of the following conditions applied:
- Procedure Purpose or Type: CLP performed exclusively for aesthetic indications.
- Cases involving intentional endodontic treatment and CLP performed solely to correct supra-eruption for prosthetic clearance (i.e., without biological indication).
- Baseline Dental and Periodontal Condition:
Teeth exhibiting furcation involvement at baseline. Mobility greater than Miller Class I preoperatively.
- Teeth functioning as abutments for fixed dental prostheses, due to altered biomechanical loading.
- Treatment Completion and Record Accuracy:
Absence or incompleteness of clinical or radiographic documentation prior to CLP. Incomplete endodontic, periodontal, or definitive restorative treatment at the time of review.
- The final restoration was not a full-coverage definitive crown.
- Follow-up and Participant Availability:
Follow-up duration less than 12 months after crown placement. Patients who declined participation or could not be contacted for consent.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
single crowns post surgical crown lenghtening
Patients who underwent surgical crown lengthening prior to receiving single-crown restorations were contacted to participate in the study.
The restored teeth were clinically and radiographically examined.
Demographic data, patient- and tooth- related details, prevalence of prosthodontic, periodontal, and/or endodontic complications, as well as failure rate with underlying reason were documented and analyzed.
|
Clinical and radiographic examinations were completed for the treated teeth.
For participants who had radiographs within past one year of examination no further radiographs were obtained.
Demographic parameters, systemic and patient-related factors such as smoking, diabetes mellitus, parafunctional habits (self-reported or diagnosed bruxism and clenching), location of tooth (maxilla or mandible, anterior or posterior), history of treated periodontitis, history of endodontic treatment, and history of regular dental attendance were documented.
Furthermore, periodontal status was evaluated by assessing mobility, probing pocket depth, bleeding index, plaque index, restorative margin position in relation to the gingival margin, and crown to root ratio based on periapical radiographs taken using long-cone parallel technique.
In addition, prosthetic factors including crown material and opposing dentition, namely tooth, crown, or removable partial denture were recorded.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Teeth survival
Time Frame: 1 year or more postintervention
|
tooth survival was defined as tooth remaining in situ with or without complications
|
1 year or more postintervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Maanas Shah, BDS MSD CAGS MRACDS, Mohammed Bin Rashid University of Medicine and Health Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MBRU-IRB-2022-97
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Crown Lengthening
-
Aristotle University Of ThessalonikiCompletedCrown Lengthening
-
Ain Shams UniversityNot yet recruiting
-
Tatyasaheb Kore Dental CollegeCompletedCrown Lengthening Procedure With OstectomyIndia
-
Cairo UniversityRecruitingCrown Lengthening | Circumferential Supracrestal Fiberotomy | Orthodontic ExtrusionEgypt
-
Amir AzarpazhoohInstitut Straumann AGCompletedPeriodontal Inflammation | Crown LengtheningCanada
-
University of Campinas, BrazilCompletedSelf Concept | Pain Postoperative | Crown LengtheningBrazil
-
University Hospital, Basel, SwitzerlandCompletedOsteotomy | Lengthening; LegSwitzerland
-
Universidad Complutense de MadridRecruitingInsufficient Clinical Crown LengthSpain
-
DMG Dental Material Gesellschaft mbHRecruiting
-
University of TennesseeActive, not recruitingProximal Muscle Strength | Proximal Muscle LengtheningUnited States
Clinical Trials on Periapical radiograph
-
T.C. Dumlupınar ÜniversitesiCompletedDental Implant Failed | Complication,Postoperative | Alveolar Bone LossTurkey
-
Qassim UniversityCompletedAnxiety | Satisfaction, Patient | Endodontic Disease | Gagging | Xray ComplicationSaudi Arabia
-
The University of Texas Health Science Center at...CompletedDental ImplantUnited States
-
Postgraduate Institute of Dental Sciences RohtakCompleted
-
University Tunis El ManarRecruitingJuvenile Idiopathic Arthritis HipTunisia
-
Postgraduate Institute of Dental Sciences RohtakUnknownChronic Apical PeriodontitisIndia
-
Saint-Joseph UniversityRecruitingPeriimplantitis | Marginal Bone LossLebanon
-
Cairo UniversityCompleted
-
Oxford University Hospitals NHS TrustUniversity of OxfordTerminatedOsteoarthritis, Knee
-
Universitaire Ziekenhuizen KU LeuvenKU LeuvenCompletedMalocclusion | Orthodontics | Cone-Beam Computed Tomography | Panoramic Radiography | Impacted Tooth | CephalometryBelgium