Comparison Between Free Gingival Graft and Palatal Pedicle Flap

NCT06816680 | Completed DMC

• 1 other identifier: 202100738A3D001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Patients requiring KMW gain(mm) during uncovering surgery were included. Two surgical methods were compared: apically position flap with free gingival graft (FGG group) and the palatal pedicle flap with collagen matrix (PPF group). The primary outcomes were KMW amount(mm) and shrinkage rate(%) at 2 weeks (2W) and 2 months (2M), 3 months (3ML), and 6 months after loading (6ML). Secondary outcomes included the intra- and inter- group comparison in mucosal recession (REC, mm), probing pocket depth (PPD, mm), marginal bone level (MBL, mm) and restoration designs.

Conditions

Peri-Implant Health; Peri-Implant Tissues; Peri-implant Bone Level

Keywords

Mucogingival Surgery; Dental Implants; Keratinized Tissue; Soft Tissue Augmentation; Free Gingival Graft; Pedicle Graft

Outcome Measures

Primary Outcomes (1)

• Keratinized mucosal width amount(mm)

  Keratinized mucosal width amount(mm) was measured with periodontal probe from mucosal margin to mucosogingival junction

  at 2 weeks (2W) and 2 months (2M), 3 months (3ML), and 6 months after loading (6ML)

Secondary Outcomes (1)

• Mucosal recession (REC, mm)

  at 2 months (2M), 3 months (3ML), and 6 months after loading (6ML)

Other Outcomes (4)

• Probing pocket depth (PPD, mm)

  2 months(2M), 3- and 6- month loading(3ML, 6ML)

• Marginal bone level (MBL, mm)

  3-month and 6 month loading(3ML, 6ML)

• Emergence profile

  3- month loading

Study Arms (2)

FGG group

ACTIVE COMPARATOR

In APF + FGG technique, a split- thickness flap was prepared and apically positioned using 5-0 (PDS\*II, Polydioxanone, ETHICON) or 6-0 (PROLENE, ETHICON) sutures for flap stabilization.

Procedure: APF + FGG

Palatal pedicle flap with collagen matrix

ACTIVE COMPARATOR

For thepalatal pedicle flap with collagen matrix (PPF) group, the palatal sliding flap was a modified version of modified roll technique, the crestal incision was placed 5 mm palatally from the border of keratinized tissue to allow for KMW redistribution, and a partially split-thickness flap was harvested from palatal connective tissue graft (CTG).

Procedure: PPF group

Interventions

APF + FGG PROCEDURE

In APF + FGG technique, a split- thickness flap was prepared and apically positioned using 5-0 (PDS\*II, Polydioxanone, ETHICON) or 6-0 (PROLENE, ETHICON) sutures for flap stabilization. To eliminate muscle and frenum attachment at recipient site, vestibuloplasty and a periosteal incision were performed. A 4 mm or 6 mm healing abutment was then screwed onto the implants. FGG was harvested from palate in a 7-8 mm width and trimmed to an even thickness of 1 to 1.5 mm. A resorbable hemostatic sponge (Spongostan, Ethicon, Johnson \& Johnson) was placed at donor site for wound coverage. For graft fixation, a loop suture with 6-0 (PROLENE, ETHICON) was first placed at the center of recipient site, additional sutures were added to enhance stabilization.

Also known as: free gingival graft

FGG group

PPF group PROCEDURE

For the PPF group, the palatal sliding flap was a modified version of modified roll technique, as described in previous cohort study. Unlike the original technique, the crestal incision was placed 5 mm palatally from the border of keratinized tissue to allow for KMW redistribution, and a partially split-thickness flap was harvested from palatal connective tissue graft (CTG). Following buccal pouch flap preparation, a slight APF was required in cases with limited vestibular depth. When the palatal pedicle CTG was rolled in buccal pouch flap, a loop suture with 6-0 (PROLENE, ETHICON) was used for flap stabilization.

Also known as: palatal pedical flap

Palatal pedicle flap with collagen matrix

Eligibility Criteria

• Age: 47 Years - 71 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient had at least one bone-level 3i implant\*: 3.25, 4, and 5 mm in diameter, 8.5, 10, and 11.5 mm in length, and primary stability with an insertion torque ≥ 20Ncm. All implants needed to be free of peri-implant disease.
• Informed consent had been obtained prior to implant uncovering.
• Insufficient keratinized mucosal width (KMW\< 2mm) was observed
• Complete data, including both clinical and radiographic outcomes, was available
• The patient followed the supportive postimplant regimen for a 12-month loading period, indicating good compliance.

You may not qualify if:

• Untreated periodontitis.
• Uncontrolled systemic disease, such as hypertension, diabetes, and heavy smokers (more than 10 pieces per day).
• History of radiation therapy on head and neck regions.
• Patient with pregnancy
• Patient had pathologic lesions around peri-implant mucosa
• Guided bone regeneration was needed concomitantly with soft tissue phenotype modification during uncovering surgery.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Taipei Chang Gung Memorial hospital

Taipei, 105, Taiwan

Location

MeSH Terms

Interventions

fibrinopeptides gamma

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patient did not know which intervention was performed, and the independent assessor of radiographic films was blinded to which intervention was done either.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients requiring KMW gain during uncovering surgery were included. Two surgical methods were compared: apically position flap with free gingival graft (FGG group) and the palatal pedicle flap with collagen matrix (PPF group). The primary outcomes were KMW amount and shrinkage rate at 2 weeks (2W) and 2 months (2M), 3 months (3ML), and 6 months after loading (6ML). Secondary outcomes included the intra- and inter- group comparison in mucosal recession (REC), probing pocket depth (PPD), marginal bone level (MBL) and restoration designs.

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: February 10, 2025
• Study Start: June 27, 2021
• Primary Completion: June 23, 2022
• Study Completion: March 7, 2023
• Last Updated: February 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)