Keratinized Tissue Augmentation Using Porcine Collagen Matrix (Mucoderm®) Around Dental Implant

NCT06753084 | Completed Phase 1 DMC

• 1 other identifier: KTW Managment
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

Aim of the Study To evaluate the using of porcine collagen matrix for keratinized tissue augmentation around delayed dental implant. Primary Outcome: Peri-implant keratinized mucosal width and thickness following the use of porcine collagen matrix using (Mucoderm®-Botiss gmbh) compared to the gold standard FGG augmentation. Secondary Outcome:

• Enhancing keratinized mucosal width and thickness
• Evaluating :
• Crestal bone change (CBC)
• perimplant Pocket depth (PD)
• Bleeding on probing (BOP)
• Plaque index (PI)
• Modified PES. T: Time A 6 months follow up .

Conditions

Keratinized Mucosa

Keywords

keratinized tissue width , porcine collagen matrix

Outcome Measures

Primary Outcomes (2)

• Keratinized mucosa width

  before the operation reading , immediately after operation , 1 month follow up , 3 months follow up and 6 months follow up the reading will done using periodontal probe

  1 month , 3 month , 6 months follow up

• keratinized tissue thickness

  measures the Keratinized tissue thickness using periodontal probe

  1 month , 3 month , 6 months follow up

Secondary Outcomes (3)

• probing depth for adjacent teeth

  6 months

• bleeding on probingn

  1 month , 3 month , 6 months follow up

• crestal bone loss around dental implant

  1 month , 3 month , 6 months follow up

Study Arms (2)

KTW augmentation using FGG

ACTIVE COMPARATOR

KTW augmentation using apically positioned flap combined with FGG from palatal mucosa

Procedure: Alloderm

KTW augmentation using porcine collagen matrix

EXPERIMENTAL

KTW augmentation using apically positioned flap combined with porcine collagen matrix

Procedure: Alloderm

Interventions

Alloderm PROCEDURE

the study is done to patient who lacks of keratinized mucosa width by apically positioned flap and using of FGG as gold standard and Mucoderm as compartive group

KTW augmentation using FGG; KTW augmentation using porcine collagen matrix

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Partially or fully edentulous sites with previous implant placed in posterior maxillary or mandibular areas.
• Inadequate keratinized tissue ≤2 3- Patient age ranged from 20 to 45 years old for both genders. 4- Submerged Osteointegrated implants with no sings of inflammation before implant insertion.
• Optimal compliance as evidenced by no missed treatment appointments and positive attitude toward oral hygiene.

You may not qualify if:

• Smokers 2- Pregnant or lactating female 3- Treatment with any systemic drug that could affect wound healing (ex- corticosteroids ) 4- History of systemic disease affect wound healing ex diabetes 5- Patient with bruxism and parafunctional habits. 6- Limited inter arch restoration space.

Sponsors & Collaborators

• ahmed amer: lead
• Misr University for Science and Technology: collaborator

Study Sites (2)

Misr university for science and technology

Giza, NJ, 08989, Egypt

Location

Misr university for science and technology

Giza, 00202, Egypt

Location

MeSH Terms

Interventions

Alloderm

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: teaching assistant periodontics department faculty of dentistry

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 31, 2024
• Study Start: November 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 25, 2024
• Last Updated: December 31, 2024

Record last verified: 2024-12

Locations

EG (2)