Autogenous vs. Xenogeneic Peri-implant Soft Tissue Grafts Placed in Full vs. Split Thickness Flaps

NCT05211115 | Completed

• 1 other identifier: 19-102
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, outcome assessor and data analyst blinded, single center trial with four parallel arms and a 1:1:1:1 allocation ratio, with the aim of comparing which combination of bilaminar technique (split vs. full thickness flap) and graft type (autogenous or xenogeneic) provides better clinical, aesthetic, morphological, vascular and patients related outcomes, when augmenting the buccal peri-implant mucosa at the reopening of submerged implant fixtures

Conditions

Thin Gingiva

Keywords

Soft tissue management; Dental implant; Collagen matrix; Connective tissue graft; Split thickness flap; Full thickness flap

Outcome Measures

Primary Outcomes (1)

• Buccal soft tissue thickness

  Changes in the thickness of the buccal peri-implant mucosa, measured with trans-gingival probing.

  before surgery, after surgery, 1 month after surgery, 6 months after surgery

Secondary Outcomes (12)

• Volume changes

  before surgery, after surgery, 14 days after surgery, 1 month after surgery, 6 months after surgery

• Attachment level

  baseline, after surgery, 1 month after surgery, 6 months after surgery

• Colorimetric integration

  1 month after surgery, 6 months after surgery

• Patients related outcome measures

  7 days after surgery, 14 days after surgery, 1 month after surgery, 6 months after surgery

• Microcirculation of the grafted area

  before surgery, after surgery, 7 days after surgery, 14 days after surgery, 1 month after surgery, 6 months after surgery

Study Arms (4)

Split thickness flap + Volume stable collagen matrix

EXPERIMENTAL

A split thickness flap will be raised with a micro-blade, keeping a flap thickness \>0,5mm. The healing abutment will be connected to the implant, and a 10mm wide, 6-8mm high, 6mm thick volume stable collagen matrix will be stabilised at the inner aspect of the flap.

Procedure: Split thickness flap; Procedure: Volume stable collagen matrix

Full thickness flap + Volume stable collagen matrix

ACTIVE COMPARATOR

A full thickness flap will be raised with a periosteal elevator. The healing abutment will be connected to the implant, and a 10mm wide by 6-8mm high volume stable collagen matrix will be stabilised at the inner aspect of the flap.

Procedure: Full thickness flap; Procedure: Volume stable collagen matrix

Split thickness flap + Autogenous connective tissue

ACTIVE COMPARATOR

A split thickness flap will be raised with a micro-blade, keeping a flap thickness \>0,5mm. The healing abutment will be connected to the implant, and a 10mm wide, 6-8mm high, 1,5mm thick autogenous sub epithelial connective tissue graft will be stabilised at the inner aspect of the flap.

Procedure: Split thickness flap; Procedure: Autogenous sub epithelial connective tissue graft

Full thickness flap + Autogenous connective tissue

ACTIVE COMPARATOR

A full thickness flap will be raised with a periosteal elevator. The healing abutment will be connected to the implant, and a 10mm wide, 6-8mm high, 1,5mm thick autogenous sub epithelial connective tissue graft will be stabilised at the inner aspect of the flap.

Procedure: Full thickness flap; Procedure: Autogenous sub epithelial connective tissue graft

Interventions

Split thickness flap PROCEDURE

Palatally displaced crestal incision at the edentulous site, combined with the split thickness elevation of a buccal flap, extended to the sulcus of the adjacent mesial and distal tooth. Flap elevation performed with a micro-blade, in a buccal and apical direction, for approximately 15mm apical to the crestal incision.

Split thickness flap + Autogenous connective tissue; Split thickness flap + Volume stable collagen matrix

Full thickness flap PROCEDURE

Palatally displaced crestal incision at the edentulous site, combined with the full thickness elevation of a buccal flap, extended to the sulcus of the adjacent mesial and distal tooth. Flap elevation performed with a fine periosteal elevator, in a buccal and apical direction, for approximately 15mm apical to the crestal incision.

Full thickness flap + Autogenous connective tissue; Full thickness flap + Volume stable collagen matrix

Autogenous sub epithelial connective tissue graft PROCEDURE

Harvest of a sub epithelial connective tissue graft using a double incision technique, approximately 2-3 mm apical to the palatal gingival margins of the first and second premolars. Graft dimension standardised as 10mm (mesio-distally) by 6-8mm (apico-coronally) by 1,5mm (thickness). Graft stabilised at the inner aspect of the buccal flap, 1mm apical to the flap margin, using one mesial and one distal horizontal mattress sutures.

Full thickness flap + Autogenous connective tissue; Split thickness flap + Autogenous connective tissue

Volume stable collagen matrix PROCEDURE

Geistlich Fibro-Gide® matrix shaped at a standardised dimension of 10mm (mesio-distally) by 6-8mm (apico-coronally) by 6mm (thickness). Matrix stabilised at the inner aspect of the buccal flap, 1mm apical to the flap margin, using one mesial and one distal horizontal mattress sutures.

Full thickness flap + Volume stable collagen matrix; Split thickness flap + Volume stable collagen matrix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any male or female adult (≥ 18 year old) patient from the University Complutense of Madrid, being able to sign an informed consent form, presenting a submerged dental implant scheduled to undergo a second stage surgery, which is bounded mesially or distally by a remaining natural tooth, and exhibits a lack of buccal soft tissue volume, will be potentially eligible for this trial.
• The case definition for a lack of buccal soft tissue volume will be the presence of a thin buccal mucosa (\< 2mm) or a minor volumetric contraction of the alveolar process (flat or concave buccal mucosal profile at the edentulous area).

You may not qualify if:

• Compromised general health status contraindicating the study procedures (≥ASA IV);
• Drug abuse, alcohol abuse, or smoking \> 10 cigarettes a day;
• Chronic use of corticosteroids, NSAIDs, or immune-modulators (any type, any dose);
• Assumption of bisphosphonates (any type, any dose, past or present);
• Pregnant or nursing women;
• Hypersensitivity to paracetamol;
• History of previous mucogingival surgeries in the area of interest;
• Lack of adequate vestibule depth to perform a bilaminar procedure;
• Lack of osseointegration at the time of implant reopening;
• Need for additional bone grafting at the time of implant reopening;
• Intraoperative evidence of a flap thickness \< 0,5mm or \> 2mm.
• \- Non compliant patients: poor oral hygiene at 2 consecutive visits.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Osteology Foundation: collaborator

Study Sites (1)

Department of Periodontology, University Complutense Madrid, Spain

Madrid, 28040, Spain

Location

Related Publications (10)

• Chappuis V, Araujo MG, Buser D. Clinical relevance of dimensional bone and soft tissue alterations post-extraction in esthetic sites. Periodontol 2000. 2017 Feb;73(1):73-83. doi: 10.1111/prd.12167.

  PMID: 28000281 RESULT

• Johnston WM, Kao EC. Assessment of appearance match by visual observation and clinical colorimetry. J Dent Res. 1989 May;68(5):819-22. doi: 10.1177/00220345890680051301.

  PMID: 2715476 RESULT

• McLean TN, Smith BA, Morrison EC, Nasjleti CE, Caffesse RG. Vascular changes following mucoperiosteal flap surgery: a fluorescein angiography study in dogs. J Periodontol. 1995 Mar;66(3):205-10. doi: 10.1902/jop.1995.66.3.205.

  PMID: 7776165 RESULT

• Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.

  PMID: 3670870 RESULT

• Perotto S, Romano F, Cricenti L, Gotti S, Aimetti M. Vascularization and Innervation of Connective Tissue Grafts in the Treatment of Gingival Recessions: A Histologic and Immunohistochemical Study. Int J Periodontics Restorative Dent. 2017 Jul/Aug;37(4):551-558. doi: 10.11607/prd.3020.

  PMID: 28609502 RESULT

• Rojo E, Stroppa G, Sanz-Martin I, Gonzalez-Martin O, Alemany AS, Nart J. Soft tissue volume gain around dental implants using autogenous subepithelial connective tissue grafts harvested from the lateral palate or tuberosity area. A randomized controlled clinical study. J Clin Periodontol. 2018 Apr;45(4):495-503. doi: 10.1111/jcpe.12869. Epub 2018 Feb 23.

  PMID: 29334403 RESULT

• Sanz-Martin I, Encalada C, Sanz-Sanchez I, Aracil J, Sanz M. Soft tissue augmentation at immediate implants using a novel xenogeneic collagen matrix in conjunction with immediate provisional restorations: A prospective case series. Clin Implant Dent Relat Res. 2019 Feb;21(1):145-153. doi: 10.1111/cid.12696. Epub 2018 Dec 3.

  PMID: 30508313 RESULT

• Tatarakis N, Gkranias N, Darbar U, Donos N. Blood flow changes using a 3D xenogeneic collagen matrix or a subepithelial connective tissue graft for root coverage procedures: a pilot study. Clin Oral Investig. 2018 May;22(4):1697-1705. doi: 10.1007/s00784-017-2261-5. Epub 2017 Oct 27.

  PMID: 29080078 RESULT

• Thoma DS, Zeltner M, Hilbe M, Hammerle CH, Husler J, Jung RE. Randomized controlled clinical study evaluating effectiveness and safety of a volume-stable collagen matrix compared to autogenous connective tissue grafts for soft tissue augmentation at implant sites. J Clin Periodontol. 2016 Oct;43(10):874-85. doi: 10.1111/jcpe.12588. Epub 2016 Aug 12.

  PMID: 27310522 RESULT

• Thoma DS, Naenni N, Figuero E, Hammerle CHF, Schwarz F, Jung RE, Sanz-Sanchez I. Effects of soft tissue augmentation procedures on peri-implant health or disease: A systematic review and meta-analysis. Clin Oral Implants Res. 2018 Mar;29 Suppl 15:32-49. doi: 10.1111/clr.13114.

  PMID: 29498129 RESULT

Study Officials

• Mariano Sanz Alonso

  Faculty of Odontology, University Complutense, Madrid, Spain

  STUDY CHAIR

• David Palombo

  Faculty of Odontology, University Complutense, Madrid, Spain

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 27, 2022
• Study Start: January 24, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 1, 2024
• Last Updated: December 19, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)