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Peri-Implant HealthPedicleNCT06816680

Comparison Between Free Gingival Graft and Palatal Pedicle Flap

A study testing APF + FGG and PPF group in people with Peri-Implant Health and Peri-Implant Tissues, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 47 to 71 yearsHealthy volunteers can take part
What is being tested?
APF + FGG and PPF group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTaiwan
Study dates
27 Jun 2021to 7 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 47 to 71 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Taipei Chang Gung Memorial hospital

    Taipei, 105

Other trials in Taiwan

About this study

Official title: Comparison of Keratinized Mucosa Width Increase Around Implants Between Palatal Pedicle Flap and Free Gingival Graft: a Clinical Controlled Trial

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.

Read the detailed description

The present prospective clinical controlled trial included patients with at least one implant requiring stage 2 surgery. All implant surgeries were performed by the same surgeon (CYL) from 2021 July to 2023 January. All included patients had to meet the following inclusion criteria:

  1. 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.
  2. Informed consent had been obtained prior to implant uncovering.
  3. Insufficient keratinized mucosal width (KMW< 2mm) was observed
  4. Complete data, including both clinical and radiographic outcomes, was available
  5. The patient followed the supportive postimplant regimen for a 12-month loading period, indicating good compliance.

Patients were excluded from this project if they have one of the following conditions:

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

Following the revised version of Helsinki Declaration in 2013, the protocol of current trial was conducted and approved by institutional review board of Chang Gung memorial hospital (IRB: 202100738A3). The cohort study was performed in accordance with STROBE statement.

2.2 Clinical Procedures Under local anesthesia, either APF combined with FGG or PPF with xenogenic matrix was performed around implants for KMW enhancement, which was concomitant with uncovering surgery.

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.

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. The exposed connective tissue bed or bone around the implants was covered with a dual- layered collagen matrix (Lyoplant®Onlay, Aesculap), and additional sutures were used for graft and flap fixation. The specific indications for the PPF technique were shown as below: (1) the total keratinized mucosa width should be more than 3 mm; (2) the vertical soft tissue height should be more than 2 mm at the time of the uncovering surgery.

Post-operative instructions were instructed individually, and the medications were prescribed (acetaminophen 500 mg, tid for 5 days; amoxicillin 375 mg, tid for 5 days) for pain and infection control during post-operative phase. Two weeks after surgery, sutures were removed, and surgical wounds were followed at recall visit 2 months later. The implant prosthesis was then restored by prosthodontic specialists. The clinical and radiographic data were collected at 3, 6, and 12 months after loading during a strict maintenance period, which involved a 3-month interval over the course of 12 months. According to the supportive strategy, routine coronal prophylaxis with ultrasonic device and titanium curettes was applied, and oral hygiene reinforcement with adequately interdental brush and superfloss was instructed at every visit.

Being tested
APF + FGG, PPF group
Keywords
Mucogingival Surgery, Dental Implants, Keratinized Tissue, Soft Tissue Augmentation, Free Gingival Graft, Pedicle Graft

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APF + FGGProcedure or surgery

    Also called free gingival graft

    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.

  • PPF groupProcedure or surgery

    Also called palatal pedical flap

    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.

Study groups in NCT06816680
Study groupRoleWhat they receive
FGG groupActive comparatorIn 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.
Receives: Procedure: APF + FGG
Palatal pedicle flap with collagen matrixActive comparatorFor 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).
Receives: Procedure: PPF group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Keratinized mucosal width amount(mm)

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

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

Secondary outcomes (1)
  1. Mucosal recession (REC, mm)

    The distance from abutment top to mucosal margin

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2025
  2. Study start27 Jun 2021
  3. Primary completion23 Jun 2022
  4. Study completion7 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06816680
Sponsor's protocol ID
202100738A3D001
Acronym
Pedicle
Status last verified
Jan 2025
First submitted
19 Jan 2025
Last updated
10 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data that support the findings of this study are available from the corresponding author upon request.

Questions about this trial

What is this clinical trial studying?

A study testing APF + FGG and PPF group in people with Peri-Implant Health and Peri-Implant Tissues, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Keratinized mucosal width amount(mm) (time frame: at 2 weeks (2W) and 2 months (2M), 3 months (3ML), and 6 months after loading (6ML)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.

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