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Gingival Recession, LocalizedNCT06000228

Effect of Vestibular Depth on Predictability of Miller Class III/ RT2 Gingival Recession Coverage

A study testing Recession coverage with CTG using minimally invasive access technique in shallow vestibule and Recession coverage with CTG using minimally invasive access technique in deep vestibule in people with Gingival Recession, Localized, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Aim of this study is to assess the influence of vestibular depth on root coverage in Miller class III/ Cairo RT2 gingival recession when treated with minimally invasive technique using connective tissue graft. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Gingival Recession, Localized
What is being tested?
Recession coverage with CTG using minimally invasive access technique in shallow vestibule and Recession coverage with CTG using minimally invasive access technique in deep vestibule
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteIndia
Study dates
15 Sep 2023to Jan 2025
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Adult patients (≥18 years) presenting with isolated Miller class III / Cairo RT2 labial gingival recession defect with deep and shallow vestibular defect.
  • Absence of clinical tooth mobility.
  • Age >18 years old.
  • A full mouth plaque index and full mouth bleeding index < 20%
  • Patient showing adequate compliance and willing to participate in the study.
  • CAL (clinical attachment level), RD (recession depth) and KTW (keratinized tissue depth) will be comparable and matched in both the groups.

Who cannot join

  • full-mouth plaque and bleeding score >20%; (2) non smoker; (3) systemic contraindications for periodontal surgery; (4) taking medications known to affect gingival homeostasis or interfere with wound healing; (5) pregnancy; (6) active orthodontic therapy; (7) previous periodontal surgery, caries, or restorations in the experimental site(s); and (8) malpositioned /crowded teeth.

Trial locations and contacts

1 site in 1 country.

Sanjay Tewari, MDS contact

01262213876

principalpgids@yahoo.in

Shikha Tewari, MDS contact

9416514600

drshikhatewari@yahoo.com

India1 site, 1 recruiting
  • Shikha Tewari

    Rohtak, Haryana, 124001

    SHIKHA TEWARI, 9416514600, drshikhatewari@yahoo.com

    Recruiting

Other trials in India

About this study

Official title: "Effect of Vestibular Depth on Root Coverage Predictability in Miller Class III/Recession Type 2 Labial Gingival Recession Treated With Minimally Invasive Technique Using Connective Tissue Graft: A Prospective Cohort Study

Aim of this study is to assess the influence of vestibular depth on root coverage in Miller class III/ Cairo RT2 gingival recession when treated with minimally invasive technique using connective tissue graft.

Read the detailed description

Gingival recession is defined as partial exposure of the root surface to the oral cavity because of apical migration of the gingival margin (GM) with respect to the cemento-enamel junction (CEJ). Miller class III/Cairo RT2 gingival recession most common gingival recession where patient complaint of root sensitivity, root caries and wedge shape defect. Several mucogingival approaches have been proposed such as tunnel techniques, coronally advanced flap(most common), connective tissue graft, rotated flap. Local factor that influences the surgical intervention and outcome therapy is interproximal bone and attachment level, marginal gingival thickness (MGT), width of attached gingiva, and recession defect depth (RD) clinical attachment level (CAL). In recent publication Aroca et al. studied influence of distance from tip of the papilla and the contact point (DCP) on recession coverage outcome and concluded that the probability to obtain a complete root coverage decreases when the DCP at baseline increases. Another finding of recent case series shown association of vestibular depth (VD) and outcome in terms of % root coverage (%RC) and complete complete coverage (CRC) and revealed that each additional 1mm VD increased 2.75 times the probability of achieving CRC but they have not compared the root coverage outcome in deep and shallow vestibular depth. Therefore, this study will be conducted in Miller class III/RT2 labial gingival recession to observed the impact of vestibular depth on root coverage when treating with minimally invasive technique using connective tissue graft.

AIM AND OBJECTIVE To assess the influence of vestibular depth on root coverage in Miller class III/ Cairo RT2 gingival recession when treated with minimally invasive technique using connective tissue graft.

Primary objective Comparative evaluation of percentage of recession coverage and complete root coverage in shallow and deep vestibular depth in Miller class III/ Cairo RT2 when treated with minimally invasive technique using connective tissue graft and also evaluated RD, RW, Gingiva phenotype, patient-based evaluation of pain and hypersensitivity by visual analogue scale(VAS)

Secondary objective To assess the improvement to other clinical parameter which will include clinical attachment level (CAL), Interdental clinical attachment, Mid buccal clinical attachment, Pocket probing depth (PPD), Bleeding on probing (BOP), Plaque index (PI), Gingival thickness (GT), Keratinized tissue width (KTW), Root aesthetic score (RES).

STUDY DESIGN Prospective cohort study

STUDY SETTING Hospital based study, and will be conducted in department of Periodontics, Post graduate institute of dental science, Rohtak.

STUDY PERIOD 12 to 14 months follow up

STUDY SUBJECT Systemically healthy individuals with Miller class III/Cairo RT2 labial gingival recession will be recruited from the outpatient department of periodontology.

Patients fulfilling the eligibility criteria will be enrolled in the study after obtaining an informed written consent.

MATERIAL AND METHOD

Patient will be educated about the procedure and its implication. Scaling and root planing is performed and then participants will be instructed about oral hygiene and undergo intervention therapy.

After administration of local anesthesia, exposed root surface will be planed using curettes or by using bur to reduce the prominent root. With a minimally invasive access technique a full thickness tunnel will be prepared with specific tunneling instruments, extending it sufficiently beyond the mucogingival line into alveolar mucosa, this will be done to completely releasing the tunnel-papillae complex, thus facilitating its passive coronal replacement. connective tissue graft will be procured from the palate or tuberosity area for root coverage procedure by single incision technique. The palatal wound will be sutured (5-0) to obtain primary wound closure Then after surgery patient will be recalled after 10 -12 days and then again at 1, 3, 6 months.

STUDY GROUPS

Experimental group- Miller class III/RT2 labial gingival recession associated with shallow vestibule.

Active comparator- Miller class III/RT2 labial gingival recession associated with deep vestibule.

STATISTICAL ANALYSIS Data recorded will be processed by standard statistical analysis. The normality of distribution of data will be examined by Shapiro Wilk test. Statistical analysis will be performed according to distribution of data. If it is in normal distribution inter group comparison will be done by using Independent T test and paired t test will be used for intragroup comparison and if non-normal distribution of data, inter group comparison will be done by Mann-Whitney U test and intragroup by signed rank test. The Chi square test will be applied to analysed categoric data. Correlation and association between predictors and dependent variables will be analysed by correlation analysis and regression analysis.

Being tested
Recession coverage with CTG using minimally invasive access technique in shallow vestibule, Recession coverage with CTG using minimally invasive access technique in deep vestibule
Medical subject headings
Gingival Recession

What participants receive

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

  • Recession coverage with CTG using minimally invasive access technique in shallow vestibuleProcedure or surgery

    After enrolment, participants will be instructed about oral hygiene and undergo nonsurgical periodontal treatment in the form of scaling and root planing using ultrasonic and hand instruments as needed. After resolution of inflammation, a full thickness tunnel will be preapred using minimally invasive access technique under local anesthesia with the aid of specific tunnelling instruments and connective tissue graft will be procured from the palate or tuberosity area for root coverage procedure by single incision technique.

  • Recession coverage with CTG using minimally invasive access technique in deep vestibuleProcedure or surgery

    After enrolment, participants will be instructed about oral hygiene and undergo nonsurgical periodontal treatment in the form of scaling and root planing using ultrasonic and hand instruments as needed. After resolution of inflammation, a full thickness tunnel will be preapred using minimally invasive access technique under local anesthesia with the aid of specific tunnelling instruments and connective tissue graft will be procured from the palate or tuberosity area for root coverage procedure by single incision technique.

Study groups in NCT06000228
Study groupRoleWhat they receive
Shallow vestibuleExperimentalMiller class III/ RT2 labial gingival recession associated with vestibular depth less than 6mm
Receives: Procedure: Recession coverage with CTG using minimally invasive access technique in shallow vestibule
Deep vestibuleActive comparatorMiller class III/ RT2 labial gingival recession associated with vestibular depth more than 6mm
Receives: Procedure: Recession coverage with CTG using minimally invasive access technique in deep vestibule

What is being measured

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

  1. percentage root coverage

    percentage of root coverage is calculated using formula: Preoperative recession depth-postoperative recession depth/ preoperative recession depth × 100

    Measured: 12-14 months

Timeline

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

  1. First posted21 Aug 2023
  2. Study start15 Sep 2023
  3. Primary completionJan 2025 (estimated)
  4. Study completionJan 2025 (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
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06000228
Sponsor's protocol ID
Sushma Periodontics 2022
Status last verified
Jan 2024
First submitted
12 Aug 2023
Last updated
12 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Recession coverage with CTG using minimally invasive access technique in shallow vestibule and Recession coverage with CTG using minimally invasive access technique in deep vestibule in people with Gingival Recession, Localized, 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 1 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 2024. 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?

Results are not available in the source record.

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

Contact Sanjay Tewari, MDS (01262213876, principalpgids@yahoo.in), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

percentage root coverage (time frame: 12-14 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 12 Jan 2024.

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