Connective Tissue Graft Versus a Porcine-derived Membrane (Mucoderm) After Immediate Placement

Immediate Implants Clinical Trial

Official title:

The Influence of a Connective Tissue Graft Versus a Porcine-derived Membrane (Mucoderm) on the Aesthetic Outcome After Immediate Placement and Loading of a Tapered Dental Implant in the Anterior Maxilla. A Randomized Controlled Clinical Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04737525
• Other study ID #: IIS1418
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: February 10, 2031

Study information

• Verified date: January 2021
• Source: Vilniaus Implantologijos Centro (VIC) Klinika
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Esthetic outcome of immediate implant placement in fresh extraction sockets remains one of the biggest challenges in implant dentistry. Recently a method to preserve the peri-implant tissues was introduced using provisional restoration, allogenic bone and soft tissue thickening. However, the evidence that this immediate provisialisation with soft tissue grafting using different grafting materials results in constantly high Pink Esthetic scores, especially compared to the delayed loading approach is still lacking. The aim of this clinical trial is to assess the esthetic outcome of immediate temporization of immediately placed and loaded tapered implants in fresh extraction sockets with bone and soft tissue augmentation, using either a connective tissue graft (CTG) or a porcine-derived membrane (Mucoderm) in maxillary anterior sites. The secondary objectives are to investigate the influence of immediate loading on the success rate of tapered implants and crestal bone levels.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: February 10, 2031
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Males and females of at least 18 years of age

2. 1 implant per patient

3. Subject must have voluntarily signed the informed consent before any study related action, are willing and able to attend scheduled follow-up visits, and agree that the pseudonymized data will be collected and analyzed

4. Anterior single teeth (canines and incisors) in both jaws

5. Class I extraction socket (intact buccal wall) or Class II (1/3 of buccal wall)

6. No recession of gingival contour of tooth to be extracted

7. No periodontal bone loss of neighboring anterior teeth

8. No implants in neighboring teeth

9. Atraumatic extraction of the tooth with intact socket walls remaining

Exclusion Criteria:

1. Deep bite (severe II class)

2. Heavy smokers (more than 10 cigarettes/day)

3. Systemic disease (diabetes, osteoporosis)

4. Primary stability after implant placement not achieved

5. Pregnancy

Related Conditions & MeSH terms

• Immediate Implants

Intervention

Device:
• Dental implant placement, bone and soft tissue augmentation on buccal site
Atraumatic extraction Palatinal positioning of tapered implant (BLX) 3.75mm diameter 3-4 mm below vestibular gingival line or 1 mm below bone crest Implant placement Allogenic bone packing of the "jumping distance" and soft tissue grafting Connective tissue graft (CTG) or porcine-derived membrane Provisional restoration out of occlusion and mandibular movements X-ray

Locations

Country	Name	City	State
Lithuania	VIC clinic	Vilnius

Sponsors (2)

Lead Sponsor	Collaborator
Vilniaus Implantologijos Centro (VIC) Klinika	Straumann Group

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aesthetic evaluation	Pink esthetic score (PES) according to Fürhauser et al. 2005 Seven variables will be evaluated: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES is 14. For the PES assessment, frontal photographs will be taken using a digital camera with a flash strobe mounted on a tripod (Canon 350d, 3456×2304 pixel resolution). PES will be assessed at baseline (Final Prosthesis), 3- and 12-month visit.	Change from baseline, 1 year, 5 and 10 years after prosthetic delivery
Secondary	Recession of gingiva (REC)	Position of the gingival/mucosal margin - recorded with a periodontal probe from the incisal edge to the margin at the zenith.	Change from baseline, 1 year, 5 and 10 years after prosthetic delivery