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Comparison Between Free Gingival Graft and Palatal Pedicle Flap

NCT06816680 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-02-10

No results posted yet for this study

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

Interventions

PROCEDURE

APF + FGG

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.

PROCEDURE

PPF group

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.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
47 Years
Max Age
71 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-27
Primary Completion
2022-06-23
Completion
2023-03-07

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06816680 on ClinicalTrials.gov