Deep Margin ElevationNCT07169305
Impact of DME on Pulpal and Periodontal Health at Varying Gingival Seat Level
A study testing Deep Margin Elevation in people with Deep Margin Elevation and Pulpal and Periodontal Health, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
The classical idea was to keep the biologic width untouched in order to maintain periodontal health but the newer case reports have given a new dimension to this concept, stating that a limited extension into STA can be used as an alternative for invasive procedures like SCL. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deep Margin Elevation, Pulpal and Periodontal Health
- What is being tested?
- Deep Margin Elevation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2025to 1 May 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients at least 18 years of age at the time of treatment.
- Permanent Posterior teeth exhibiting proximal caries lesion extending subgingivally below the cemento-enamel junction (CEJ). The axial extent of the caries should not be more than 75% of the dentin thickness.
- Sound tooth structure of atleast 1mm should be present from the alveolar crest to the base of the cavity/ gingival seat after cavity preparation.
- The tooth should either be asymptomatic or have reversible pulpitis as determined by history and pulp sensibility testing. There should be no history of spontaneous or lingering pain
- Periodontally sound tooth
- Full mouth plaque score (FMPS): ≤ 15% and Full mouth bleeding score (FMBS): ≤15%
Who cannot join
- Presence of bone disease (metabolic, endocrine, infectious, tumoral, developmental pathologies)
- Pregnant or lactating and history of smoking or alcohol abuse
- Anti inflammatory drug consumption within past 3 days
- Uncontrolled or poorly controlled diabetes
- Unstable Life threatening conditions or requiring antibiotic prophylaxis.
- Presence of detectable plaque and Bleeding on probing on the tooth to be treated
Show all 13Show fewer
- Thin gingival biotype, Periodontitis and Gingival recession
- Class II cavities with gingival margin above the CEJ
- Previously restored teeth
- Absence of adjacent tooth or antagonist or Crown in adjacent tooth.
- H/o Bruxism, Xerostomia
- Requiring gingivectomy
- Isolation with rubber dam not possible
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
PGIDS
Rohtak, Haryana, 124001
Dr. Mayank Arora, MDS, 8295964200, dr.arora002@gmail.com
Dr. Swathi C, Post Graduate student, 8618677427, swathic188@gmail.com
About this study
Official title: Impact of DME on Pulpal and Periodontal Health at Varying Gingival Seat Level in Class II Subgingival Composite Restorations
The classical idea was to keep the biologic width untouched in order to maintain periodontal health but the newer case reports have given a new dimension to this concept, stating that a limited extension into STA can be used as an alternative for invasive procedures like SCL. The periodontal tissues can still tolerate subgingival margin placement in biologic width when restorations are free of overhangs which are real culprit for providing room for plaque retention and further inflammation. There are no sufficient clinical studies with good sample size to prove the significance of this concept. Hence, we are performing a Non Randomized Controlled trial by placing gingival margins at various levels above the alveolar crest and restoring it with composite and further evaluate the periodontal tissue health, pulpal health, restoration quality and significance of DME.
Read the detailed description
Rationale: Deep margin Elevation is a technique used in restorative dentistry which helps in dealing with deep Subgingival margins. The placement of gingival seat in relation to crestal bone significantly influences pulpal and periodontal health. Biologic width is essential for maintaining healthy periodontal tissues, but the effect of limited violations needs to be evaluated. Less invasive procedures like DME are preferable alternative to surgical crown lengthening. Aims \& Objectives: 1.To evaluate and compare the effect of DME performed in Class II at ≥3mm, 2mm to <3mm, 1mm to <2mm above alveolar crest on pulpal health 2.To evaluate and compare the effect of DME performed in Class II at ≥3mm, 2mm to <3mm, 1mm to <2mm above alveolar crest on gingival health 3.To evaluate and compare the effect of DME performed in Class II at ≥3mm, 2mm to <3mm, 1mm to <2mm above alveolar crest on restoration quality.
Population - Adult patients with class II cavities at ≥3mm, 2mm to <3mm, 1mm to <2mm above the alveolar crest. Intervention - DME performed in Class II cavities at 2mm to <1mm and 1mm to <2mm above the alveolar crest with composite. Comparator- DME performed in Class II cavities at ≥3mm above the alveolar crest with Composite. Outcome- Clinical performance according to USPHS criteria, Periodontal parameters i.e. Probing depth and CAL, Gingival Index and Plaque Index.
- Being tested
- Deep Margin Elevation
- Keywords
- Deep margin elevation, Pulpal and Periodontal health, Class II Composite restorations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Margin ElevationProcedure or surgery
The tooth preparation is performed using conventional diamond burs. The extent of caries decides the group into which the participant falls. A precontoured sectional matrix (Palodent) with a properly sized plastic diamond wedge (Bioclear Matrix Systems) is applied and stabilized using a separating ring to ensure closure of deep cervical margins, adaptation of the matrix cervically and attain contact tightness. A 37% phosphoric acid etch gel is used for Selective Enamel Etching technique for 15-20 seconds. Two coats of adhesive are applied to both enamel and dentin using a microbrush and light cured. Flowable bulkfill composite (SDR plus, Dentsply, Sirona) restorative composite is placed using teflon coated hand instruments to perform DME till the level of CEJ and light cured for 20s. Further build up of proximal box is done using packable composite. The restoration is finished using fine grit yellow coded tapered diamond stones. Polishing done by using Composite Polishing kits.
| Study group | Role | What they receive |
|---|---|---|
| Class II cavities 2mm to <3mm above the alveolar crest | Experimental | DME is performed in Class II cavities 2mm to <3mm above the alveolar crest and restored with composite. Receives: Procedure: Deep Margin Elevation |
| Class II cavities 1mm to <2mm above the alveolar crest | Experimental | DME is performed in Class II cavities 1mm to <2mm above the alveolar crest and restored with composite. Receives: Procedure: Deep Margin Elevation |
| Class II cavities ≥3mm above the alveolar crest | Active comparator | DME is performed in Class II cavities ≥3mm above the alveolar crest and restored with composite. Receives: Procedure: Deep Margin Elevation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal Parameters
Probing Depth
Measured: Baseline to 12 months
Secondary outcomes (1)
Periodontal parameters and restoration quality
CAL, Plaque Index, Gingival Index. United States Public Health Service (USPHS) criteria for restoration quality
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 May 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Margin ElevationStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Mayank Arora, MDS, Principal investigator, PGIDS, Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169305
- Sponsor's protocol ID
- Swathi C
- Status last verified
- Apr 2025
- First submitted
- 15 May 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of DME on Pulpal and Periodontal Health at Varying Gingival Seat Level in Class II Subgingival Composite Restorations
- ClinicalTrials.gov ID
- NCT07169305
- Acronym / sponsor ID
- Swathi C
- Keywords
- Deep margin elevation, Pulpal and Periodontal health, Class II Composite restorations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 11 Sep 2025 (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 classical idea was to keep the biologic width untouched in order to maintain periodontal health but the newer case reports have given a new dimension to this concept, stating that a limited extension into STA can be used as an alternative for invasive procedures like SCL. The periodontal tissues can still tolerate subgingival margin placement in biologic width when restorations are free of overhangs which are real culprit for providing room for plaque retention and further inflammation. There are no sufficient clinical studies with good sample size to prove the significance of this concept. Hence, we are performing a Non Randomized Controlled trial by placing gingival margins at various levels above the alveolar crest and restoring it with composite and further evaluate the periodontal tissue health, pulpal health, restoration quality and significance of DME.
Detailed description
Rationale: Deep margin Elevation is a technique used in restorative dentistry which helps in dealing with deep Subgingival margins. The placement of gingival seat in relation to crestal bone significantly influences pulpal and periodontal health. Biologic width is essential for maintaining healthy periodontal tissues, but the effect of limited violations needs to be evaluated. Less invasive procedures like DME are preferable alternative to surgical crown lengthening. Aims \& Objectives: 1.To evaluate and compare the effect of DME performed in Class II at ≥3mm, 2mm to <3mm, 1mm to <2mm above alveolar crest on pulpal health 2.To evaluate and compare the effect of DME performed in Class II at ≥3mm, 2mm to <3mm, 1mm to <2mm above alveolar crest on gingival health 3.To evaluate and compare the effect of DME performed in Class II at ≥3mm, 2mm to <3mm, 1mm to <2mm above alveolar crest on restoration quality.
Population - Adult patients with class II cavities at ≥3mm, 2mm to <3mm, 1mm to <2mm above the alveolar crest. Intervention - DME performed in Class II cavities at 2mm to <1mm and 1mm to <2mm above the alveolar crest with composite. Comparator- DME performed in Class II cavities at ≥3mm above the alveolar crest with Composite. Outcome- Clinical performance according to USPHS criteria, Periodontal parameters i.e. Probing depth and CAL, Gingival Index and Plaque Index.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Class II cavities 2mm to <3mm above the alveolar crest | Experimental | Procedure: Deep Margin ElevationDME is performed in Class II cavities 2mm to <3mm above the alveolar crest and restored with composite. |
| Class II cavities 1mm to <2mm above the alveolar crest | Experimental | Procedure: Deep Margin ElevationDME is performed in Class II cavities 1mm to <2mm above the alveolar crest and restored with composite. |
| Class II cavities ≥3mm above the alveolar crest | Active comparator | Procedure: Deep Margin ElevationDME is performed in Class II cavities ≥3mm above the alveolar crest and restored with composite. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients at least 18 years of age at the time of treatment.
Key exclusion criteria (13 listed)
- Presence of bone disease (metabolic, endocrine, infectious, tumoral, developmental pathologies)
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 |
|---|---|---|
| Deep Margin ElevationThe tooth preparation is performed using conventional diamond burs. The extent of caries decides the group into which the participant falls. A precontoured sectional matrix (Palodent) with a properly sized plastic diamond wedge (Bioclear Matrix Systems) is applied and stabilized using a separating ring to ensure closure of deep cervical margins, adaptation of the matrix cervically and attain contact tightness. A 37% phosphoric acid etch gel is used for Selective Enamel Etching technique for 15-20 seconds. Two coats of adhesive are applied to both enamel and dentin using a microbrush and light cured. Flowable bulkfill composite (SDR plus, Dentsply, Sirona) restorative composite is placed using teflon coated hand instruments to perform DME till the level of CEJ and light cured for 20s. Further build up of proximal box is done using packable composite. The restoration is finished using fine grit yellow coded tapered diamond stones. Polishing done by using Composite Polishing kits. | Procedure or surgery | Class II cavities 1mm to <2mm above the alveolar crest, Class II cavities 2mm to <3mm above the alveolar crest, Class II cavities ≥3mm above the alveolar crest |
Primary outcome
Periodontal Parameters
Time frame: Baseline to 12 months
Probing Depth
1 secondary outcome
Periodontal parameters and restoration quality
Time frame: Baseline to 12 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 11 Sep 2025.
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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.
Dr. Mayank Arora, MDS principal investigator
PGIDS, Rohtak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Margin Elevation in people with Deep Margin Elevation and Pulpal and Periodontal Health, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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 6 inclusion and 13 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 11 Sep 2025. 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 India. 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 Dr. Mayank Arora (8295964200, drarora002@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal Parameters (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2025.