Keratinized Tissue Gain Following Apically Positioned Flap with and Without Free Gingival Graft Strip

NCT06694623 | Completed

• 2 other identifiers: 106/2-2023Faculty of Dentistry Pancevo
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

In non-implant edentulous patients reduction of height and width of residual alveolar ridge and reduced attached KT compromise the denture-bearing area unambiguously leading to decrease in full denture stability and retention. Furthermore, in implant edentulous patients insufficient KT is associated with increased plaque accumulation, tissue inflammation, soft tissue recession, marginal bone loss and increased prevalence of peri-implantitis. The present study aimed to evaluate keratinized tissue gain and the wound contraction rate between apically positioned flap without and with free gingival graft strip over a 6-month follow up period. This research was designed as split mouth controlled clinical study included 17 patients having edentulous upper jaw with reduced width of keratinized tissue ( ≤ 4mm measured from middle of the crest to the buccal mucogingival junction or ≤ 2mm from occluso-buccal edge of the alveolar ridge to the mucogingival junction). In each patient, both surgical techniques, apically positioned flap without and with free gingival graft strip, were applied simultaneously. The change of keratinized tissue width and wound contraction rate were measured 30, 60 , 90 and 180 days after surgery

Conditions

Keratinized Mucosa

Keywords

keratinized mucosa; free gingival graft strip; apically positioned flap; wound contraction

Outcome Measures

Primary Outcomes (1)

• Wound contraction rate

  Percentage of tissue tissue contraction during healing period

  From enrollment to the 180 day

Secondary Outcomes (3)

• Pain

  1, 2, 7 and 10 day postoperatively

• number of ibuprofen tablets

  1, 2, 7, 10 days postoperatively

• Surgery duration

  From start to the end of surgery

Study Arms (2)

apically positioned flap alone

ACTIVE COMPARATOR

apically positioned flap alone

Procedure: Apically positioned flap

apically positioned flap with FGG strip

ACTIVE COMPARATOR

apically positioned flap with FGG strip

Procedure: Apically positioned flap with FGG strip

Interventions

Apically positioned flap PROCEDURE

The split thickness flap was apically positioned as much as possible and sutured to the periosteum utilizing T-mattress sutures.

apically positioned flap alone

Apically positioned flap with FGG strip PROCEDURE

The split thickness flap was apically positioned as much as possible and sutured to the periosteum utilizing T-mattress sutures. FGG strip was sutured to the apical end of recipient bed.

apically positioned flap with FGG strip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with edentulous upper jaws which are not able to wear full upper denture owing to compromise retention and stability being 18 years old or older,
• patients with reduced width of keratinized tissue (≤ 4mm) measured from middle of the crest to the buccal mucogingival junction ( the distance from occluso-buccal edge of the alveolar ridge to the mucogingival junction ≤ 2mm), - patients who belong to ASA1 or ASA2, according to the American Academy to Anesthesiology
• patients who do not suffer from any systemic disease affecting wound healing,
• patients which are able to provide a signed informed consent and are able to comply with determined follow-up time points.

You may not qualify if:

• patient is a heavy smoker (more than 10 cigarettes per day),
• patients with history of malignancy, radiotherapy or chemotherapy within the 5 years,
• pregnant or nursing patients,
• patients who are taking medications which have an effect on mucosal healing in general (steroids, non-steroidal anti-inflammatory drugs taken in high doses and in long term, bisphosphonates).

Sponsors & Collaborators

• Adam Malesevic: lead
• University of Belgrade: collaborator

Study Sites (1)

Faculty of Dentistry Pancevo

Pančevo, Serbia, 26000, Serbia

Location

Related Publications (6)

• Urban IA, Lozada JL, Nagy K, Sanz M. Treatment of severe mucogingival defects with a combination of strip gingival grafts and a xenogeneic collagen matrix: a prospective case series study. Int J Periodontics Restorative Dent. 2015 May-Jun;35(3):345-53. doi: 10.11607/prd.2287.

  PMID: 25909521 BACKGROUND

• Arnoux JP, Papasotiriou A, Weisgold AS. A revised technique for stage-two surgery in the severely resorbed mandible: a technical note. Int J Oral Maxillofac Implants. 1998 Jul-Aug;13(4):565-8.

  PMID: 9714965 BACKGROUND

• Gamal N, Shemais N, Al-Nawawy M, Ghallab NA. Post-extraction volumetric analysis of alveolar ridge contour using subepithelial connective tissue graft in esthetic zone: a randomized controlled clinical trial. Clin Oral Investig. 2023 Nov;27(11):6503-6512. doi: 10.1007/s00784-023-05255-0. Epub 2023 Sep 19.

  PMID: 37726486 BACKGROUND

• Song YW, Yoon SW, Cha JK, Jung UW, Jung RE, Thoma DS. Soft Tissue Dimensions Following Tooth Extraction in the Posterior Maxilla: A Randomized Clinical Trial Comparing Alveolar Ridge Preservation to Spontaneous Healing. J Clin Med. 2020 Aug 10;9(8):2583. doi: 10.3390/jcm9082583.

  PMID: 32784997 BACKGROUND

• De Angelis P, De Rosa G, Manicone PF, De Giorgi A, Cavalcanti C, Speranza A, Grassi R, D'Addona A. Hard and soft tissue evaluation of alveolar ridge preservation compared to spontaneous healing: a retrospective clinical and volumetric analysis. Int J Implant Dent. 2022 Dec 8;8(1):62. doi: 10.1186/s40729-022-00456-w.

  PMID: 36480055 BACKGROUND

• Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.

  PMID: 12956475 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Model Details: Split mouth

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 19, 2024
• Study Start: March 1, 2023
• Primary Completion: December 15, 2023
• Study Completion: October 10, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)