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Gingival Recession, LocalizedNCT05682274

Effect of Restoration Margin Level in the Treatment of Gingival Recession Associated With Non-carious Cervical Lesion

A study testing Partial restoration approach combined with CAF+CTG in people with Gingival Recession, Localized, run by Gazi University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this randomized, parallel-group clinical trial was to compare the 1-year periodontal, root coverage, esthetic, and patient-centered outcomes of the partial restoration placement with different apical margin levels combined with coronally advanced flap (CAF) plus connective tissue graft (CTG) in the… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Gingival Recession, Localized
What is being tested?
Partial restoration approach combined with CAF+CTG
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Oct 2021to 1 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Gingival recession of at least 1 mm depth.
  • There is no loss of interdental support (RT-1)
  • Cervical step greater than 0.5 mm
  • Inability to detect CEJ (Class B+)
  • Maximum root closure level at the NCCL's deepest point (Type 3)
  • Individuals who do not have any systemic disease that would preclude surgery
Show all 13Show fewer
  • Who are not pregnant
  • Who are not smokers or who smoke less than 5 cigarettes per day
  • Who have a whole mouth plaque and bleeding score of 10%
  • Patients who do not require endodontic treatment in the surgical area and do not have tooth mobility;
  • Patients who do not require orthodontic treatment;
  • Patients who do not have periodontal disease; and
  • Patients who do not have restoration and/or filling in the recession area.

Who cannot join

  • Smokers
  • Pregnant
  • Having a systemic disease that may deteriorate wound healing
  • Poor oral hygiene
  • Patients with active periodontal disease
  • Tooth devitalization

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gazi University Faculty of Dentistry

    Ankara, 06490

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Placement of the Apical Margin of the Restoration in the Treatment of Gingival Recession Associated With Non-carious Cervical Lesion With Combined Restorative and Periodontal Therapy

The aim of this randomized, parallel-group clinical trial was to compare the 1-year periodontal, root coverage, esthetic, and patient-centered outcomes of the partial restoration placement with different apical margin levels combined with coronally advanced flap (CAF) plus connective tissue graft (CTG) in the treatment of isolated gingival recessions associated with non-carious cervical lesions (NCCL). Forty patients with single gingival recessions (RT1 gingival recessions and class B+ NCCL) were randomly allocated to either placement of restoration apical margin at the level of estimated cementoenamel junction (CEJ) or within 1 mm apical to the CEJ. Two weeks after the restorative treatment, all recession defects were treated with CAF combined with CTG. Periodontal measurements were taken at baseline, and 3, 6, and 12 months postoperatively. Patient-centered outcomes were evaluated at baseline, and 7, and 15 days, 6, and 12 months postoperative follow-ups. Modified root closure aesthetic score (mRES) was used to assess aesthetics at 6 and 12 months follow-ups.

Read the detailed description

Gingival recessions associated with non-carious cervical lesions (NCCL) involving the CEJ area, which form a combined defect (CD), can lead to complex soft tissue management during periodontal plastic surgeries and result in poor clinical/aesthetic outcomes. Since CD encompasses both hard and soft tissue loss, different periodontal/restorative multidisciplinary protocols have been suggested to treat this challenging situation. Reconstruction of the coronal portion of NCCL with a resin composite filling (partial restoration approach) before the surgical procedure has been suggested to present favorable and predictable outcomes in the treatment of gingival recessions associated with NCCL. For the partial restoration approach, two different protocols to restore the most coronal zone of the NCCL have been proposed according to the extension of the apical margin of the restoration, which are the placements at the level of CEJ or within 1 mm apical to the CEJ. Both approaches have some advantages and disadvantages. After root coverage procedures, if complete closure has been achieved, placing the apical restoration margin at the estimated CEJ level would allow the gingival margin to contact only the root surface and not cover the apical part of the restoration. However, in cases with incomplete root coverage, the placement of the restoration border 1 mm apically of the CEJ could prevent the formation of a gap between the gingival margin and the apical border of the restoration that results in esthetic compromises, and the persistence of dentin hypersensitivity. However, there is no study in the literature comparing these two different locations of the apical border of the restoration in periodontal/restorative combined therapy. Therefore, the aim of this study was to compare the 1-year periodontal, root coverage, esthetic, and patient-centered outcomes of the partial restoration placement with different apical margin levels combined with CAF plus CTG in the treatment of isolated gingival recessions associated with NCCL.

Material and Methods

This randomized, parallel-group clinical study recruited 40 systemically healthy patients, who were admitted to Gazi University Faculty of Dentistry, Department of Periodontology with complaints of sensitivity and aesthetic problems due to gingival recession. The patients were randomly assigned to the study groups: group I, partial restoration with the apical border at the level of CEJ in combination with CAF+CTG; group II, partial restoration with apical border within 1 mm apical to the CEJ.

The location of the CEJ prior to the restorative treatment was identified using the method developed by Zuchelli et al. 2006.

The gingival margin to the most coronal of the NCCL, as well as the width and depth of the NCCL, were measured before and after the restorative treatment. Periodontal parameters were measured with a periodontal probe (UNC 15) at baseline, and 3, 6, and 12 months postoperatively. Plaque index (PI), gingival index (GI), probing depth (PD), bleeding on probing (BOP), clinical attachment level (CAL), recession depth (RD), recession width (RW), keratinized tissue width (KTW), and gingival thickness (GT) were all measured and recorded.

The flap thickness, graft width, height, and thickness were measured during the procedures. On the 7th and 14th days, postoperative pain, sensitivity, and aesthetic scores were determined using a 0-10 visual analog scale in the patient-based evaluation (VAS). Furthermore, the modified root closure aesthetic score (mRES) was used to assess aesthetics objectively at the 6 and 12-month follow-ups.

Restorative procedure

The defect surface was roughened with 37% orthophosphoric acid before being washed and dried while still moist. The adhesive resin was then applied to the surface as directed by the manufacturer. 3M ESPE, Deutchland GmbH, Neuss, GERMANY (Single Bond Universal). Finally, a 2 mm thick restorative material (Tetric Evo Ceram, Ivoclar Vivadent, Schaan, Liechtenstein) was applied to the restoration area and polymerized by applying light for 20 seconds. Finally, the restoration surfaces were polished, and the restoration margins were checked with a blunt-tipped probe. Two weeks later, the patients underwent periodontal surgery.

Surgical Technique

Following the CEJ, a sulcular incision was made in the gingival margin of the tooth using a microblade, and a horizontal incision was made from the tooth with recession to the adjacent teeth. The vertical incision towards the apex and the horizontal incision was then intersected. The muscle attachments were cut after gentle elevation. A split-full-split thickness flap was raised up beyond the MGJ. A gentle root debridement was performed using a sharp curette up to 1 mm from the bone crest. CPF technique designed by Zuchelli and De Sanctis (2000) was performed. Then the flap was elevated and CTG, which was fixed with the coronal border at the level of restored CEJ, was sutured. The flap was stabilized and sutured 1-2 mm above the restored CEJ with a 6/0 Teflon suture.

Obtaining CTG from Palatinal Mucosa

The graft margins were determined with a 15C scalpel by making two horizontal incisions parallel to the palatal midline of the preferred donor area and two vertical incisions perpendicular to them, 2 mm away from the apical of the gingival margin of the teeth so that the distal extension of the incision ends at the mesial border of the first molar. The graft's epithelial surface was removed extra orally (0.3-0.5 mm) with the reflection of the scalpel tip visible. The graft was de-epithelialized and placed in a petri dish with physiological saline.

Care was taken to ensure that the was de-epithelialized approximately 1 mm thick, similar to conventional free gingival grafts. By controlling the bleeding in the donor area, a hemostatic sponge was sutured using the vertical cross-suture technique.

Post-operative Care

The patients were recommended not to brush the operation area for 2 weeks and were instructed to use 0.12% CHX (Kloroben, Drogsan Istanbul, Turkey) mouthwash twice a day. For post-operative pain, patients were advised to take 400 mg of the non-steroidal anti-inflammatory drug (ibuprofen) twice a day for 14 days. Sutures were removed 14 days after the operation.

Being tested
Partial restoration approach combined with CAF+CTG
Keywords
Gingival recession, Tooth abrasion, Composite resin, Connective tissue graft, Dental sensitivity
Medical subject headings
Gingival Recession, Tooth Abrasion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Partial restoration approach combined with CAF+CTGProcedure or surgery

    The location of the CEJ prior to the restorative treatment was identified using the method developed by Zuchelli et al. 2006. The placement of the apical margin of the restoration was performed either at the level of estimated cementoenamel junction (CEJ) or within 1 mm apical to the CEJ. Two weeks after the restorative treatment, all recession defects were treated with CAF combined with CTG.

Study groups in NCT05682274
Study groupRoleWhat they receive
Group IActive comparatorPartial restoration with the apical border at the level of CEJ in combination with CAF+CTG
Receives: Procedure: Partial restoration approach combined with CAF+CTG
Group IIActive comparatorPartial restoration with the apical border within 1 mm apical to the CEJ.
Receives: Procedure: Partial restoration approach combined with CAF+CTG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in gingival recession height

    Immediately after reconstruction of CEJ, gingival recession height was measured and accepted as baseline value. This value was obtained by the difference between 12th month gingival recession height and baseline recession height

    Measured: 12 months after the surgery

Secondary outcomes (8)
  1. Mean root coverage

    Measured: 12 months after the surgery

  2. Complete root coverage

    Measured: 12 months after the surgery

  3. Modified root closure aesthetic score

    Modified root closure aesthetic score was evaluated six variables. Gingival margin: 0 or 3 points; marginal tissue contour: 0 or 1 point; soft tissue texture: 0 or 1 point; mucogingival junction alignment: 0 or 1 point; gingival colour: 0 or 1 point; restoration/cervical lesion colour: 0 points = colour of restoration or uncovered cervical lesion does not match tooth colour; 3 points = good colour integration. The total higher score means more favorable outcomes.

    Measured: 12 months after the surgery

  4. Dental sensitivity by visual analogue scale

    This scale is a 10-centimeter horizontal line with scores of 0 and 10 at their ends, where 0 = no sensitivity and 10 = severe sensitivity.

    Measured: 12 months after the surgery

  5. Self-perceived aesthetic satisfaction by visual analogue scale

    This scale is a 10-centimeter horizontal line with scores of 0 and 10 at their ends, where 0 = no satisfaction and 10 = fully satisfied

    Measured: 12 months after the surgery

  6. Clinical attachment level

    Measured: 12 months after the surgery

  7. Probing depth

    Measured: 12 months after the surgery

  8. Soft tissue thickness phenotype

    Measured: 12 months after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2023
  2. Study start1 Oct 2021
  3. Primary completion20 Jan 2023 (estimated)
  4. Study completion1 Feb 2023 (estimated)

Resources

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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05682274
Sponsor's protocol ID
E-21071282-050.99-108427
Status last verified
Jan 2023
First submitted
25 Dec 2022
Last updated
12 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zucchelli G, Gori G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M. Non-carious cervical lesions associated with gingival recessions: a decision-making process. J Periodontol. 2011 Dec;82(12):1713-24. doi: 10.1902/jop.2011.110080. Epub 2011 May 4.

    PubMed 21542735
  • Yang S, Lee H, Jin SH. A combined approach to non-carious cervical lesions associated with gingival recession. Restor Dent Endod. 2016 Aug;41(3):218-24. doi: 10.5395/rde.2016.41.3.218. Epub 2016 May 2.

    PubMed 27508164
  • Cairo F, Cortellini P, Nieri M, Pilloni A, Barbato L, Pagavino G, Tonetti M. Coronally advanced flap and composite restoration of the enamel with or without connective tissue graft for the treatment of single maxillary gingival recession with non-carious cervical lesion. A randomized controlled clinical trial. J Clin Periodontol. 2020 Mar;47(3):362-371. doi: 10.1111/jcpe.13229. Epub 2020 Jan 7.

    PubMed 31811742
  • de Sanctis M, Di Domenico GL, Bandel A, Pedercini C, Guglielmi D. The Influence of Cementoenamel Restorations in the Treatment of Multiple Gingival Recession Defects Associated with Noncarious Cervical Lesions: A Prospective Study. Int J Periodontics Restorative Dent. 2020 May/Jun;40(3):333-342. doi: 10.11607/prd.4639.

    PubMed 32233184
  • Pini-Prato G, Franceschi D, Cairo F, Nieri M, Rotundo R. Classification of dental surface defects in areas of gingival recession. J Periodontol. 2010 Jun;81(6):885-90. doi: 10.1902/jop.2010.090631.

    PubMed 20450362
  • Cairo F, Rotundo R, Miller PD, Pini Prato GP. Root coverage esthetic score: a system to evaluate the esthetic outcome of the treatment of gingival recession through evaluation of clinical cases. J Periodontol. 2009 Apr;80(4):705-10. doi: 10.1902/jop.2009.080565.

    PubMed 19335093
  • Cairo F, Pini-Prato GP. A technique to identify and reconstruct the cementoenamel junction level using combined periodontal and restorative treatment of gingival recession. A prospective clinical study. Int J Periodontics Restorative Dent. 2010 Dec;30(6):573-81.

    PubMed 20967303
  • Zucchelli G, Testori T, De Sanctis M. Clinical and anatomical factors limiting treatment outcomes of gingival recession: a new method to predetermine the line of root coverage. J Periodontol. 2006 Apr;77(4):714-21. doi: 10.1902/jop.2006.050038.

    PubMed 16584355
  • Santamaria MP, Queiroz LA, Mathias IF, Neves FL, Silveira CA, Bresciani E, Jardini MA, Sallum EA. Resin composite plus connective tissue graft to treat single maxillary gingival recession associated with non-carious cervical lesion: randomized clinical trial. J Clin Periodontol. 2016 May;43(5):461-8. doi: 10.1111/jcpe.12524. Epub 2016 Apr 13.

    PubMed 26847486

Questions about this trial

What is this clinical trial studying?

A study testing Partial restoration approach combined with CAF+CTG in people with Gingival Recession, Localized, run by Gazi University at 1 site in Turkey (Türkiye).

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 13 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Jan 2023. 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 Turkey (Türkiye). 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in gingival recession height (time frame: 12 months after the surgery). 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 NCT05682274, which also lists 9 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 12 Jan 2023.

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