- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07380126
The Effect of Functional Crown Lengthening Versus Deep Margin Elevation on Periodontal Tissues
The Effect of Functional Crown Lengthening Versus Deep Margin Elevation on Periodontal Tissues (A Randomized Clinical Trial With Biochemical Analysis)
The present study will evaluate and compare the effect of functional CL and DME in the treatment of posterior teeth with class II caries clinically and on the level of TNF-α in the GCF of treated teeth.
Clinical evaluation of periodontal tissue in the form of probing depth as a primary outcome, clinical attachment level, plaque index, bleeding index, gingival index, pink aesthetic score, Radiographic evaluation of biological width and the level of TNF-α in the GCF as a secondary outcome.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In dental practice, restoring cavitated proximal caries lesions is a common routine procedure in dental clinics. However, subgingival margins reaching below the cementoenamel junction are known to have a common clinical concern, especially when restoring severely destructed Class II caries. Ideally, the correct choice of treatment plan is critical to ensure successful outcomes (Padbury et al., 2003).
The use of direct adhesive restoration to restore large interproximal defects is not an ideal treatment option. Due to their size, such defects usually require indirect adhesive restorations. However, this appears to be challenging since cavity preparation, impression taking, the adhesive-bonding procedure, and proper moisture control may be impeded. These challenges are usually overcomed by functional crown lengthening (Mangani et al.,2015; Juloski et al.,2018).
Functional Crown lengthening is a surgical procedure to expose the gingival margins by apical displacement of the supporting periodontal structures, thus can facilitate an access and adequate isolation to achieve the optimum position of deep restorations and avoid violating the biological width (Magne & Spreafico, 2012; Sarfati & Tirlet, 2018).
The biological width is defined as the gingival attachment along the root surface, from the most coronal portion of the epithelium attachment to the most apical portion of the connective tissue attachment (Gargiulo et al.,1961). Therefore, a recommended distance of 3 mm or more between the restorative margins and the alveolar crest is considered necessary to avoid detrimental effects on neighbouring soft and hard periodontal tissues (Ingber et al.,1977; Lanning et al., 2003). The violation of the biological width results in severe gingival inflammation and consequently deep pocket formation or gingival recession, in addition to bone level reduction (Nugala et al., 2012).
Recurrence usually occurs particularly in patients with thick biotypes or when surgery comprises only gingivectomy. Moreover, recurrence leads to restoration limits being replaced sub-gingivally, whereas surgery aims to place them sub-gingivally (Ganji et al.,2012)..
A more conservative approach is the deep marginal elevation (DME), which is considered an atraumatic procedure advocated in the presence of deep cervical margins (Dietschi & Spreafico,1998; Veneziani,2010).
The concept of "deep margin relocation" was introduced in 1998 by Dietschi and Spreaficoas a new approach to deep caries. It was later renamed "deep margin elevation" by Magne and Spreafico in 2012. It is a procedure done to raise the margins of the tooth to either an equi-gingival or supra-gingival position using restorative materials. This technique is referred to by different names, including the "open sandwich technique," "proximal box elevation," and the "margin elevation technique" (Dietschi & Spreafico,1998; Dietschi et al.,2003).
A dry working field is crucial to the success of restoration, especially in deep cavities reaching the Cemento-enamel junction. The presence of saliva and blood causes contamination and deterioration to the restoration and affects the bonding to the tooth structure (Keys & Carson,2017).
DME allows appropriate placement of a rubber dam to a perfectly placed margin, adequate light-curing depth to the margin of restoration, accessibility to proper oral hygiene, and an ultraconservative approach to evaluate bone and soft tissue (Frankenberger et al.,2013; Zaruba et al.,2013). Studies have shown promising results using DME and high survival rates of up to 90% over a 12-year clinical evaluation (Bresser et al.,2019).
A randomized clinical trial compared the clinical results of crown lengthening and DME in posterior teeth. At 180 days, clinical attachment loss was higher in the surgical group (Bresser et al., 2019). Many studies have reported that DME procedures do not negatively affect periodontal health status and suggest they are well tolerated by the periodontium when proper isolation is achieved (Frese et al.,2014; Sarfati & Tirlet, 2018).
However, the gingival phenotype must be analysed as among teeth treated with subgingival restorations, those presenting <2 mm of keratinized tissue showed higher gingival index (Stetler & Bissada,1987).
Debate continues as to whether a non-invasive elevated margin technique or surgical CL is the better strategy for facilitating the placement of large direct composite resin restorations. Though a conservative approach is often advocated, it fails in situations that demand change in the shape of tissues around the tooth for restoration (Sarfati & Tirlet, 2018).
To the best of our knowledge, no previous study measured the effect of crown lengthening on inflammatory biomarkers in the gingival crevicular fluid in comparison to deep margin elevation in posterior teeth with deeply located proximal margins.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mahmoud A. Ezz, Bachelor
- Phone Number: +201091702356 +201092921800
- Email: mahmoudezz210000@gmail.com
Study Contact Backup
- Name: Hadeel G. Al Malahy, Associate Professor
- Phone Number: +201017767662
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria :
- Patients aged 20-50 years
- Both genders
- Patients free from any systemic disease that may affect the treatment (Greenberg & Glick, 2012)
- Patients with intact periodontium
- Patients are ready to comply with oral hygiene measures.
- Patients having Posterior teeth with carious cavities and/ or restorations in need of replacement on proximal surfaces, where the cervical margin of the cavity is at a distance less than 3 mm to the bone crest (Cyana et al.,2013).
- Patients with thick phenotype having gingival thickness > 1mm (Aimetti et al,2008).
- Patients with keratinized tissue width ≥ 2mm
Exclusion criteria:
- Pregnant and lactating females
- Smokers
- Drug abusers.
- Patients with persistent poor oral hygiene
- Patients with proximal margins beyond the bone level
- Patients with developmental dental anomalies
- Patients undergoing or will start orthodontic treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Functional crown lengthening
patients will undergo functional crown lengthening by raising a full thickness flap with osseous resection to establish a distance of 3 mm between the cervical margin of the cavity and the bone crest.
Osteoplasty was performed in the adjacent and neighboring tooth surfaces to accomplish a smooth bone contour.
The flaps will then be sutured in their new position
|
patients will undergo functional crown lengthening by raising a full thickness flap with osseous resection to establish a distance of 3 mm between the cervical margin of the cavity and the bone crest.
Osteoplasty was performed in the adjacent and neighboring tooth surfaces to accomplish a smooth bone contour.
The flaps will then be sutured in their new position
|
|
Active Comparator: Deep Margin Elevation
patients will undergo deep margin elevation through a two-step direct restoration performed using the concepts of Progressive Matrixing and Wedging where the Deep subgingival cavity margin will be acquired.
Then isolation by rubber dam.
A curved matrix will seal the margin without any gingival or rubber dam entrapped in between.
One step adhesive system will be performed under rubber dam isolation.
Composite resin base is applied to raise the margin by about 2 mm.
A bulk fill packable or flowable composite can be used.
Finishing will be done using polishing strips and disks.
Finally a bitewing radiograph will be taken to check the presence of overhangs or gaps before the final restoration.
|
patients will undergo deep margin elevation through a two-step direct restoration performed using the concepts of Progressive Matrixing and Wedging where the Deep subgingival cavity margin will be acquired.
Then isolation by rubber dam.
A curved matrix will seal the margin without any gingival or rubber dam entrapped in between.
One step adhesive system will be performed under rubber dam isolation.
Composite resin base is applied to raise the margin by about 2 mm.
A bulk fill packable or flowable composite can be used.
Finishing will be done using polishing strips and disks.
Finally a bitewing radiograph will be taken to check the presence of overhangs or gaps before the final restoration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Probing depth
Time Frame: Clinical measurements preoperative and will be repeated at 1, 3, and 6 months
|
Will be measured from the gingival margin to the depth of the pocket at four points (mesio-facial, mid-facial, disto-facial and mid-lingual) to the nearest millimeter using UNC-15 periodontal probe.
The average of the three facial points will be recorded as the facial probing depth (FPD), while the mid-lingual point will be recorded as the lingual probing depth.
|
Clinical measurements preoperative and will be repeated at 1, 3, and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biochemical evaluation
Time Frame: Biochemical measurements preoperative and will be repeated at 1, 3 and 6 months
|
GCF samples will be collected to measure the level of TNF-α in treated teeth.
Before sampling, the adjacent teeth will be isolated with cotton rolls.
Crevicular fluid will be collected on perio paper strips placed parallel to the long axis of the tooth of concern in the gingival sulcus until mild resistance is felt and kept for 30 seconds and pooled in reduced transport fluid (RTF) medium for biochemical analysis.
GCF collected samples contaminated with blood and saliva will be discarded
|
Biochemical measurements preoperative and will be repeated at 1, 3 and 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Doaa A. Khattab, Associate Professor, Faculty of Dentistry - Ain Shams University
Publications and helpful links
General Publications
- Padbury A Jr, Eber R, Wang HL. Interactions between the gingiva and the margin of restorations. J Clin Periodontol. 2003 May;30(5):379-85. doi: 10.1034/j.1600-051x.2003.01277.x.
- Aimetti M, Massei G, Morra M, Cardesi E, Romano F. Correlation between gingival phenotype and Schneiderian membrane thickness. Int J Oral Maxillofac Implants. 2008 Nov-Dec;23(6):1128-32.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- FDASU-Rec IM022410
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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