NCT04692558

Brief Summary

Gingival marginal tissue recession is the displacement of the soft tissue margin apical to the cementoenamel junction (CEJ) with exposure of the root surface. It is a common clinical finding in patients with high standards of oral hygiene and can be found in more than 90% of patients. Buccal exposure of roots leading to esthetic concerns and dentinal hypersensitivity are the most frequent reasons for patients to seek treatment for the same. Gingival recession therapy is still challenging for clinicians. The ultimate goal of root coverage procedures is the complete coverage of the recession defect with an esthetic appearance comparable to adjacent healthy soft tissues in combination with physiological probing pocket depths. Various treatment modalities have been put forth for the correction of gingival recession. These include free gingival autograft, subepithelial connective tissue graft (SCTG), coronally advanced flap (CAF) and various combinations. Coronally advanced flap (CAF) in conjunction with the connective tissue graft (CTG) is considered the gold standard of treatment of gingival recession due to its high predictability of the treatment results. Several authors have explored the use of biological agents or like enamel matrix derivative (EMD), platelet-derived growth factor-BB (PDGF), fibroblast growth factor-2 (FGF-2), which are a group of proteins capable of inducing gene or cell activation for cell recruitment, matrix biosynthesis, and cellular differentiation, in an attempt to regenerate the lost periodontium to enhance its long term stability Hyaluronic acid (HA) is one such biologic agent that demonstrates future for periodontal regeneration. It is a major component of the extracellular matrix in almost all tissues. The primary role of HA is to bind water and to allow the transportation of key metabolites and therefore to maintain the structural and homeostatic integrity of these tissues. HA suppresses tissue breakdown activating metalloproteinase inhibitors. It represents one of the most hygroscopic molecules known in nature. As a physical background material, it functions as space filler, lubricant and a protein excluder as well. In vitro studies and animal studies have demonstrated that HA significantly increases the tensile strength of granulation tissue, stimulates clot formation, induces angiogenesis, increases osteogenesis, and does not interfere in the calcification nodules during bone formation. Furthermore, HA facilitates cell migration and differentiation during tissue formation and repair of both soft and hard tissues. It improves ligament cell viability and early osteogenic differentiation. Considering the fact that HA has positive effects on wound healing, we hypothesized that it may also improve the results of root coverage by CAF+CTG. Therefore, the aim of this randomized controlled clinical trial (RCT) will be to evaluate the potential benefit of the adjunctive use of HA in combination with CAF+CTG and to compare the outcomes with CAF+CTG alone, when treating single Miller class I and class II/RT1gingival recessions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

January 2, 2020

Completed
1 year until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

1.8 years

First QC Date

December 13, 2019

Last Update Submit

December 30, 2020

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (6)

  • The difference in recession depth (RD)

    \- measured as the distance from CEJ to the gingival margin.

    6 MOonths

  • complete root coverage (CRC)

    PERCENTAGE OF 100% ROOT COVERAGE

    6 Months

  • mean root coverage (MRC)

    MEASUREMENT OF AMOUNT OF COVERAGE OBTAINED OVER ALL

    6 Months

  • • Gingival recession width (GRW)

    measured as the distance between the mesial gingival margin (measurement will be recorded on a horizontal line tangential to the cementoenamel junction)

    6 Months

  • gingival thickness

    In the direct method, the tissue thickness is measured using a periodontal probe.

    6 Months

  • root coverage esthetic scores (RES).

    Root coverage esthetic score: a system to evaluate the esthetic outcome of the treatment of gingival recession through evaluation of clinical cases. ... This score evaluates five variables: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color.

    6 Months

Secondary Outcomes (8)

  • Pocket probing depth

    6 Months

  • clinical attachment level (CAL)

    6 Months

  • width of keratinized tissue (KTW)

    6 Months

  • plaque index (PI)

    6 Months

  • gingival index (GI)

    6 Months

  • +3 more secondary outcomes

Study Arms (2)

HYALURONIC ACID

EXPERIMENTAL

CAF+CTG+HA

Biological: HYALURONIC ACIDProcedure: coronally advanved flap with connective tissue harvesting

WITHOUT HYALURONIC ACID

ACTIVE COMPARATOR

CAF+CTG

Procedure: coronally advanved flap with connective tissue harvesting

Interventions

HYALURONIC ACIDBIOLOGICAL

Hyaluronic acid will be applied on denuded root surface after reflection of isolated gingival recession.

Also known as: HA
HYALURONIC ACID
coronally advanved flap with connective tissue harvestingPROCEDURE

Coronally advanced flap surgery with connective tissue harvesting from palate

Also known as: CAF+CTG
HYALURONIC ACIDWITHOUT HYALURONIC ACID

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients willing to participate in the study.
  • Age ≥ 18 to 55 years of age.
  • Patients with healthy or treated periodontal condition.
  • Full-mouth plaque score (FMPS) \< 15%.
  • Presence of at least one buccal recession (depth ≥ 2 mm) with no loss of interproximal attachment classified as Miller class I,II RT/1 in the anterior maxillary or mandibular area (central and lateral incisors, canine, and first and second premolars).
  • Associated with esthetic problems and/or dental hypersensitivity.
  • Gingival recession with at least 1 mm of keratinized tissue (KT) apical to the recession and thick gingival biotype (\>0.8mm gingival thickness)

You may not qualify if:

  • Active periodontal disease at sites (probing pocket depth \< 4 mm and no bleeding on probing).
  • Pregnant or lactating females.
  • Tobacco smoking.
  • Uncontrolled medical conditions.
  • Untreated periodontal conditions.
  • Use of systemic antibiotics in the past 3 months.
  • Patients treated with any medication known to cause gingival hyperplasia.
  • Drug and alcohol abuse.
  • Occlusal interferences.
  • History of mucogingival or periodontal surgery at the experimental site.
  • Patients with a known hypersensitivity or allergy to hyaluronic acid.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Krishnadevaray College of Dental Science and Hospital

Bangalore, Karnataka, 562157, India

RECRUITING

Related Publications (2)

  • Pilloni A, Schmidlin PR, Sahrmann P, Sculean A, Rojas MA. Effectiveness of adjunctive hyaluronic acid application in coronally advanced flap in Miller class I single gingival recession sites: a randomized controlled clinical trial. Clin Oral Investig. 2019 Mar;23(3):1133-1141. doi: 10.1007/s00784-018-2537-4. Epub 2018 Jun 30.

    PMID: 29961138BACKGROUND

  • Kumar R, Srinivas M, Pai J, Suragimath G, Prasad K, Polepalle T. Efficacy of hyaluronic acid (hyaluronan) in root coverage procedures as an adjunct to coronally advanced flap in Millers Class I recession: A clinical study. J Indian Soc Periodontol. 2014 Nov-Dec;18(6):746-50. doi: 10.4103/0972-124X.147411.

    PMID: 25624632BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • PRABHUJI MLV, MDS

    Krishnadevaraya College of Dental Sciences & Hospital

    STUDY DIRECTOR

Central Study Contacts

JOANN PAULINE GEORGE, MDS

CONTACT

9448541637drpaulinegeorge@gmail.com

SUSAN S, MDS

CONTACT

7619297823suziejazz.23@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2019

First Posted

January 5, 2021

Study Start

January 2, 2020

Primary Completion

October 30, 2021

Study Completion

October 30, 2021

Last Updated

January 5, 2021

Record last verified: 2020-12

Locations

IN(1)