TNF AlphaNCT07380126
The Effect of Functional Crown Lengthening Versus Deep Margin Elevation on Periodontal Tissues
A study testing Functional Crown lengthening and Deep Margin Elevation in people with TNF Alpha, run by Ain Shams University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- TNF Alpha
- What is being tested?
- Functional Crown lengthening and Deep Margin Elevation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Oct 2026
- Phase
- Interventional
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Hadeel G. Al Malahy, Associate Professor contact
About this study
Official title: 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.
Read the 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.
- Conditions
- TNF Alpha
- Being tested
- Functional Crown lengthening, Deep Margin Elevation
- Keywords
- Functional Crown lengthening, Deep Margin Elevation, TNF-α
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Crown lengtheningProcedure or surgery
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
Deep Margin ElevationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Functional crown lengthening | Experimental | 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 Receives: Procedure: Functional Crown lengthening |
| Deep Margin Elevation | Active comparator | 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. Receives: Procedure: Deep Margin Elevation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth
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.
Measured: Clinical measurements preoperative and will be repeated at 1, 3, and 6 months
Secondary outcomes (1)
Biochemical evaluation
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
Measured: Biochemical measurements preoperative and will be repeated at 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TNF AlphaStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Doaa A. Khattab, Associate Professor, Study director, Faculty of Dentistry - Ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380126
- Sponsor's protocol ID
- FDASU-Rec IM022410
- Status last verified
- Jan 2026
- First submitted
- 24 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 12716328Aimetti 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.
PubMed 19216284
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Functional Crown Lengthening Versus Deep Margin Elevation on Periodontal Tissues (A Randomized Clinical Trial With Biochemical Analysis)
- ClinicalTrials.gov ID
- NCT07380126
- Acronym / sponsor ID
- FDASU-Rec IM022410
- Conditions
- TNF Alpha
- Keywords
- Functional Crown lengthening, Deep Margin Elevation, TNF-α
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 2 Feb 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional crown lengthening | Experimental | Procedure: Functional Crown lengtheningpatients 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 |
| Deep Margin Elevation | Active comparator | Procedure: Deep Margin Elevationpatients 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- Pregnant and lactating females
- Smokers
- Drug abusers.
- Patients with persistent poor oral hygiene
- Patients with proximal margins beyond the bone level
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 |
|---|---|---|
| Functional Crown lengtheningpatients 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 | Procedure or surgery | Functional crown lengthening |
| Deep Margin Elevationpatients 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. | Procedure or surgery | Deep Margin Elevation |
Primary outcome
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.
1 secondary outcome
Biochemical evaluation
Time frame: Biochemical measurements preoperative and will be repeated at 1, 3 and 6 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 2 Feb 2026.
- Background: PubMed 12716328Padbury 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.
- Background: PubMed 19216284Aimetti 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.
- Individual participant dataSharing planned: Undecided
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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.
Hadeel G. Al Malahy, Associate Professor contact
Doaa A. Khattab, Associate Professor study director
Faculty of Dentistry - Ain shams university
Questions about this trial
What is this clinical trial studying?
A study testing Functional Crown lengthening and Deep Margin Elevation in people with TNF Alpha, run by Ain Shams University.
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 8 inclusion and 7 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: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Mahmoud A. Ezz, Bachelor (+201092921800 ext. +201091702356, mahmoudezz210000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depth (time frame: Clinical measurements preoperative and will be repeated at 1, 3, and 6 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 NCT07380126, which also lists 2 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 2 Feb 2026.