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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06753084
Enrollment
22
Registered
2024-12-31
Start date
2023-11-01
Completion date
2024-07-25
Last updated
2024-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratinized Mucosa

Keywords

keratinized tissue width , porcine collagen matrix

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: 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 .

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

Interventions

PROCEDUREAlloderm

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

Sponsors

Misr University for Science and Technology
CollaboratorOTHER
ahmed amer
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Keratinized mucosa width1 month , 3 month , 6 months follow upbefore 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
keratinized tissue thickness1 month , 3 month , 6 months follow upmeasures the Keratinized tissue thickness using periodontal probe

Secondary

MeasureTime frameDescription
probing depth for adjacent teeth6 monthsprobing depth for adjacent teeth
bleeding on probingn1 month , 3 month , 6 months follow upbleeding on probing for this patient is mesure using papillary bleeding index.
crestal bone loss around dental implant1 month , 3 month , 6 months follow upmeasuring crestal bone loss around implant using CBCT and periapical xray

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026