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

Keratinized Tissue Augmentation Using Porcine Collagen Matrix (Mucoderm®) Around Dental Implant: A Randomized Clinical Study

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:

1. Crestal bone change (CBC)
2. Pocket depth (PD)
3. Bleeding on probing (BOP)
4. Plaque index (PI) PICOT

P: Population:

Patient with suitable ridge dimension for delayed implant placement.

I: Intervention:

Implant insertion followed by porcine collagen matrix soft tissue augmentation

C: Control:

Autogenous FGG

O: Outcomes

• Enhancing keratinized mucosal width and thickness

• Evaluating :

  1. Crestal bone change (CBC)
  2. perimplant Pocket depth (PD)
  3. Bleeding on probing (BOP)
  4. Plaque index (PI)
  5. Modified PES. T: Time A 6 months follow up .

Study Overview

• Status: Completed
• Conditions: Keratinized Mucosa
• Intervention / Treatment: Procedure: Alloderm

Detailed Description

this study aiming to augment KMW with FGG and MUCODERM following apically positioned flap the primary outcomes to measure is KMW and MT

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 00202
    • Misr University for Science and Technology
  • NJ
    • Giza, NJ, Egypt, 08989
      • Misr University for Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1- Partially or fully edentulous sites with previous implant placed in posterior maxillary or mandibular areas.

  2- 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.

  5- Optimal compliance as evidenced by no missed treatment appointments and positive attitude toward oral hygiene.

Exclusion Criteria:

• 1- 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: KTW augmentation using FGG; KTW augmentation using apically positioned flap combined with FGG from palatal mucosa	Procedure: Alloderm; 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
Experimental: KTW augmentation using porcine collagen matrix; KTW augmentation using apically positioned flap combined with porcine collagen matrix	Procedure: Alloderm; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
probing depth for adjacent teeth	probing depth for adjacent teeth	6 months
bleeding on probingn	bleeding on probing for this patient is mesure using papillary bleeding index.	1 month , 3 month , 6 months follow up
crestal bone loss around dental implant	measuring crestal bone loss around implant using CBCT and periapical xray	1 month , 3 month , 6 months follow up

Collaborators and Investigators

• Sponsor: ahmed amer
• Collaborators: Misr University for Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): July 25, 2024

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 21, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 21, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: keratinized tissue width , porcine collagen matrix
• Other Study ID Numbers: KTW Managment

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: after thesis discussion we will decide

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No