Clinical trial NCT04195737: Comparison of Coronally Advanced Root Coverage Procedure With Collagen Matrix and Connective Tissue Graft
Official title: Comparative Evaluation of Coronally Advanced Root Coverage Procedure With Ossix Volumax™ Collagen Matrix and Connective Tissue Graft-Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: Gingival Recession Coverage
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups were made one test and control. The test group will be treated with coronally advanced flap with ossix volumax™ collagen matrix and control group will be treated with coronally advanced flap with Sub epitheial Connective Tissue Graft.
Primary purpose: TREATMENT

Brief summary: The present study is a human, prospective, randomised controlled clinical trial conducted to explore the outcome of a coronally advanced flap with ossix volumaxTM collagen matrix and connective tissue graft in the treatment of multiple adjacent gingival recession defects.

The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

Detailed description: Periodontal plastic surgery are surgical procedures performed to prevent or correct anatomic, developmental, traumatic or disease-induced defects of the gingiva, alveolar mucosa or bone. It includes various soft and hard tissue procedures aimed at gingival augmentation, root coverage, correction of mucosal defects at implants, crown lengthening, gingival preservation at ectopic tooth eruption, removal of aberrant frena, prevention of ridge collapse associated with tooth extraction and augmentation of the edentulous ridge.1

Different predisposing anatomic features can result in recession such as position and anatomy of teeth in the dental arch, bony dehiscence, thickness of the alveolar mucosa, muscle pull, orthodontic treatment, thin gingival biotype, buccal prominence of teeth, lack of keratinized tissue, abnormal frenum attachment, or patient related factors such as vigorous brushing or chronic gingival inflammation.2 The migration of the marginal tissue to an apical position may lead to esthetic concern, dentin hypersensitivity, root caries, and cervical wear. Treatment modalities for gingival recession have many influencing factors such as defect dimensions (depth, width), site (maxilla, mandible), defect number (single, multiple), soft tissue anatomy (keratinized tissue quality/quantity; papilla height/width; frenum/ muscle pull; vestibular depth) tooth position etc.

Various surgical techniques for the treatment of recessions includes the use of full or partial thickness flap with various soft tissue grafts such as epithelized free gingival grafts (FGG) or sub-epithelial connective tissue graft (SCTG) in conjunction with various types of flaps eg: (envelope, coronally or laterally positioned flap, double pedicle flap (DPF) or tunnelling (TUN) alone or combined with laterally positioned pedicle flaps (LPPF).3 Coronally advanced flap (CAF) with connective tissue graft (CTG) is considered as the gold standard treatment for gingival recession. Commercially available materials for root coverage are expanded Poly Tetra Fluoro Ethylene (Gore-Tex), polglactin, Collagen membranes like biogide, biomend, resolute, alloderm, collatape etc, collagen matrix such as mucograft, human amniotic membrane, dermagraft, ossix.4

Recently in a case report using platelet concentrate carried on collagen sponge (ossix) showed favourable results.4 Ossix volumax™ has shown De novo bone formation when used in alveolar ridge augmentation procedure.5

Ossix volumax™ (Datum dental) is one such recently identified sugar cross-linked bio programmed collagen matrix. Ossix volumax™ is a volumizing, thick collagen scaffold, featuring glymatrix technology. The properties are thick and expand when wet, excellent handling, easy to use, adapts and adheres to the bone.5 It undergoes rapid ossification (in CT scans and histology after one month).6

Literature search till date has shown no studies regarding the use of type 1 sugar cross-linked collagen membrane for treatment of gingival recession. So, the present study is undertaken with the aim to comparatively evaluate the advantages of ossix volumax collagen membrane with subepithelial connective tissue graft for the treatment of multiple adjacent gingival recession defects.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to18 years.
* Multiple adjacent Miller's class I and class II gingival recession sites.
* Patients with healthy or treated periodontal conditions.
* Patients with esthetic concerns.
* Absence of uncontrolled medical conditions.
* Full mouth plaque score \</= 10% (O'Leary 1972)
* Full mouth bleeding score \<10% (Ainamo and Bay 1975)

Exclusion Criteria:

* Gingival biotype less than 0.8 mm.
* Pregnant or lactating females.
* Tobacco smoking.
* Untreated periodontal conditions.
* Use of systemic antibiotics in the past 3 months.
* Patients treated with any medication known to cause gingival hyperplasia

Primary outcomes:
measure: gingival recession depth
timeFrame: 6 months
measure: Complete root coverage
timeFrame: 6 months
measure: Mean root coverage
timeFrame: 6 months
Secondary outcomes:
measure: pocket Probing depth
timeFrame: 6 months
measure: Gingival Recession width
timeFrame: 6 months
measure: Clinical attachment level
timeFrame: 6 months
measure: Gingival biotype thickness
timeFrame: 6 months
measure: Apico-coronal width of keratinized tissue
timeFrame: 6 months
measure: Root coverage esthetic score
timeFrame: 6 months
measure: Plaque index
timeFrame: 6 months
measure: Gingival index
timeFrame: 6 months
measure: Gingival Bleeding index
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Krishnadevaraya college of dental sciences
state: Karnataka
Study officials:
affiliation: Krishnadevarya Dental College
name: Prabhuji MLV
role: STUDY_DIRECTOR
References: