Edentulous Sites Augmented With Collagen Matrix or CTG

Edentulous Alveolar Ridge Clinical Trial

Official title:

Volumetric Changes at Edentulous Sites Augmented With Collagen Matrix or Connective Tissue Graft: a Randomized Clinical Trial With 6 Months Follow up

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04915677
• Other study ID #: GFGTurin1
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: March 10, 2024

Study information

• Verified date: February 2023
• Source: University of Turin, Italy
• Contact: Mario Aimetti
• Phone: 00390116331546
• Email: mario.aimetti[@]unito.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ridge deformities can complicate prosthetic rehabilitation, especially in situations where optimal esthetic outcomes are desired. Simpler, less invasive and predictable treatments are needed in order to obtain soft tissue augmentation at edentulous ridges. Autogenous subepithelial connective tissue graft (SCTG) has always been regarded as the treatment of choice, but heterologous volume stable collagen matrix (VCMX) is emerging as a reliable alternative. The principal aim of the present RCT will be to compare the volumetric buccal soft tissue changes at edentulous areas after augmentation procedure using VCMX or SCTG. Parameters related to periodontal health at adjacent teeth and patient reported outcomes (PROMs) will be also assessed as secondary outcomes. Proving the non- inferiority of VCMX compared to SCTG would provide the specialists and general clinicians with an easier, less invasive and better tolerated technique for soft tissue augmentation at edentulous ridges and for improving aesthetic and cleansability of the prosthetic rehabilitation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: March 10, 2024
• Est. primary completion date: June 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Intercalated mono-edentulous area ridge defects to be rehabilitated with fixed partial bridge
• At least 18 years old
• At least 6 months from tooth extraction at the study area.

Exclusion Criteria:

• Systemic diseases which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus);
• Smoking = 10 cigarettes a day;
• Pregnant or nursing women;
• Chronic use of corticosteroids or other anti-inflammatory or immune-modulator drugs;
• Patients who need use of medications affecting bone metabolism or oral mucosa;
• Presence of a congruous FDP at the edentulous area;
• History of soft tissue augmentation surgery in the study area;
• Active periodontitis
• Uncompliant patients

Related Conditions & MeSH terms

• Edentulous Alveolar Ridge
• Mouth, Edentulous

Intervention

Procedure:
• Soft tissue augmentation with subepithelial connective tissue graft (SCTG)
After local anesthesia a mesio-distal crestal incision will be performed reaching the alveolar bone. Split thickness dissection performed both buccal and palatal. Subepithelial connective tissue graft will be harvested and inserted beneath the mucoperiosteal flap and stretched buccally and lingually using a modified horizontal mattress suture. The flap margins at the crest will be adapted using single interrupted sutures in order to achieve a primary closure of the flap.
• Soft tissue augmentation with xenogenic volume stable collagen matrix
After local anesthesia a mesio-distal crestal incision will be performed reaching the alveolar bone. Split thickness dissection performed both buccal and palatal. Xenogenic volume stable collagen matrix will be inserted beneath the mucoperiosteal flap and stretched buccally and lingually using a modified horizontal mattress suture. The flap margins at the crest will be adapted using single interrupted sutures in order to achieve a primary closure of the flap.

Locations

Country	Name	City	State
Italy	University of Turin	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volumetric buccal soft tissue changes (-5 to +5 mm with positive values representing an increase in volume)	Mean linear change in mm from baseline to 6 months follow-up	6 months
Secondary	Change in Probing Pocket Depth (PD) at adjacent teeth (0-15 mm with higher values representing worse outcomes)	The distance between cementoenamel junction (CEJ) and the base of the pocket	6 months
Secondary	Mucosal recession at adjacent sites (0-15 mm with higher values indicating worse outcomes)	The distance between the cementoenamel junction (CEJ) and the mucosal margin	6 months
Secondary	Pain (VAS scale)(0-10 with higher values indicating worse outcomes)	Subjective pain experienced by the patient expressed in a VAS scale	2 weeks