Comparison of Connective Tissue Graft Versus Titanium Papillary Inserts in the Surgical Reconstruction of Interdental Papilla.

NCT07401667 | Completed

• 1 other identifier: SVSIDS/PERIO/4/2022
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Aim and Objectives: The study aimed to evaluate the effectiveness of titanium inserts for interdental papilla reconstruction, comparing it with the Han and Takei technique using subepithelial connective tissue grafts. The objectives included assessing the black triangle height, papilla height and papilla presence index (PPI) at baseline, 1 month and 3 months post operatively along with the evaluation of Early Wound Healing Score (EHS) during the first week of post operative healing period. Patients and Methods: This single-blind randomized clinical trial included systemically healthy individuals aged 18-35 years with Nordland and Tarnow's Class I-III papillary loss. A total of 18 participants were randomly assigned to either test group or control group. Clinical parameters were measured pre- and post-operatively at specified intervals. Both groups received standard presurgical care and postoperative follow-up. The surgical protocol for the test group involved titanium insert placement in the interdental bone, while the control group received a connective tissue graft using the Han and Takei method.

Conditions

Papilla Reconstruction

Keywords

Connective tissue grafts; titanium inserts; black triangle; papilla height; papilla reconstruction

Outcome Measures

Primary Outcomes (3)

• Interdental papilla height

  To be measured from base of the papilla (a line joining the two adjacent teeth gingival zenith) to the tip of the papilla. Measured with UNC-15 probe.

  3 MONTHS

• Black triangle height

  Measurement from the tip of the interdental papilla to the apical-most point of the contact point. Measured using a digital vernier caliper.

  3 MONTHS

• Papilla presence index (PPI)

  given by Cardaropoli et al

  3 MONTHS

Secondary Outcomes (1)

• Early Wound Healing Score (EHS)

  1 WEEK

Study Arms (2)

TITANIUM INSERTS FOR PAPILLA RECONSTRUCTION

EXPERIMENTAL

Device: TITANIUM INSERTS

SUB-EPITHELIAL CONNECTIVE TISSUE GRAFT FOR PAPILLA RECONSTRUCTION USING HAN & TAKEI TECHNIQUE

ACTIVE COMPARATOR

Procedure: CONNECTIVE TISSUE GRAFT

Interventions

TITANIUM INSERTS DEVICE

The titanium papillary insert2 is composed of a pyramidal- shaped polished titanium core; it has a height of 2 to 3 mm and a base that is 3 mm bucco-lingually and 1 mm in the mesio-distal dimension. It also has mesial and distal concavities to allow for the emergence of the papilla. It is fitted into the bone between two adjacent teeth by means of a self-taping screw extension that is 0.8 mm in diameter and 5 mm in length.

TITANIUM INSERTS FOR PAPILLA RECONSTRUCTION

CONNECTIVE TISSUE GRAFT PROCEDURE

CTG is widely used across a broad range of clinical indications in periodontal and peri-implant therapy. It is primarily indicated for the treatment of gingival recession, reduction of dentinal hypersensitivity, and correction of mucogingival deformities.

SUB-EPITHELIAL CONNECTIVE TISSUE GRAFT FOR PAPILLA RECONSTRUCTION USING HAN & TAKEI TECHNIQUE

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically healthy male and female patients with a stable periodontal health of age 18-35 years.
• Patients with Nordland and Tarnow's1 Class I, II, III interdental papillary loss at a single site and Gingival recession \< 2 mm on the facial aspect.
• Patients presenting with adequate width of attached gingiva (2-3mm)
• Having a thick gingival biotype (2 mm)

You may not qualify if:

• Midline diastema patients
• Medically compromised patients
• Pregnant and lactating women
• Heavy smokers,
• Patient who underwent radiotherapy \& chemotherapy,
• Patients with any bleeding or clotting disorders
• Patients not willing to participate in the study.

Sponsors & Collaborators

• Dr R Viswa Chandra: lead
• SVS Institute of Dental Sciences: collaborator

Study Sites (1)

Svs Institute of Dental Sciences

Mahbūbnagar, Telangana, 509001, India

Location

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 INVESTIGATOR
• PI Title: PROFESSOR AND HEAD OF DEPARTMENT

Study Record Dates

• First Submitted: August 30, 2025
• First Posted: February 10, 2026
• Study Start: May 21, 2023
• Primary Completion: December 21, 2024
• Study Completion: May 21, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

IN (1)